Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03481634
Other study ID # CRTH258B2301
Secondary ID 2017-004742-23
Status Completed
Phase Phase 3
First received
Last updated
Start date July 23, 2018
Est. completion date October 18, 2021

Study information

Verified date January 2023
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).


Description:

This was a Phase III, randomized, double-masked, multi-center, active-controlled, three-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg and 3 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with diabetic macular edema (DME). The study included a screening period of up to 2 weeks to assess eligibility, followed by a doublemasked treatment period (Day 1 to Week 96). The baseline visit was defined as Day 1/Visit 1, and end of treatment visit as Visit 27 (Week 96). After the last treatment visit, a post-treatment follow-up period was planned from Week 96 to Week 100. Subjects were assigned to one of three treatment arms in a 1:1:1 ratio: brolucizumab 6 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/every 8 weeks (q8w) during maintenance phase, brolucizumab 3 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/q8w during maintenance phase or aflibercept 2 mg/0.05 mL administered 5 x every 4 weeks (q4w) during loading phase then q8w during maintenance phase. Disease Activity Assessments (DAAs) were conducted by the masked investigator for each treatment arm at Week 32 and Week 36, i.e. 8 and 12 weeks after the end of the loading phase for subjects receiving brolucizumab. Assessments were also performed at Week 48, and will then continue to be performed from Week 60 up to Week 96, every 12 weeks. Subjects in the brolucizumab arms who qualified for q12w during the initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at any of the subsequent DAA visits, in which case subjects were switched to a q8w treatment interval until the end of the study. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP). The unmasked site personnel and unmasked injecting investigator did not perform Best-corrected visual acuity (BCVA), complete ophthalmic examination (with the exception of post-injection safety assessment), DAAs or administer the Visual Functioning Questionnaire-25 (VFQ-25). Also, the unmasked site personnel and unmasked injecting physician did not perform assessment of any ocular or non-ocular safety parameters, or assess causality of Adverse event (AEs) for subjects during the course of the study except an event reported immediately following Intravitreal treatment (IVT). Once the designated roles were determined, the unmasked investigator/site personnel roles were not switched at any time after randomization to masked role. Every effort was made to limit the number of unmasked study personnel to ensure the integrity of this masked study.


Recruitment information / eligibility

Status Completed
Enrollment 566
Est. completion date October 18, 2021
Est. primary completion date November 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Written informed consent before any assessment - Patients with type 1 or type 2 diabetes mellitus and HbA1c of =10% at screening - Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study Exclusion Criteria: - Active proliferative diabetic retinopathy in the study eye - Active intraocular or periocular infection or active intraocular inflammation in study eye - Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg) - Previous treatment with anti-VEGF drugs or investigational drugs in the study eye - Stroke or myocardial infarction during the 6-month period prior to baseline - Uncontrolled blood pressure defined as a systolic value =160 mmHg or diastolic value =100 mmHg Other protocol-specified inclusion/exclusion criteria may apply

Study Design


Intervention

Drug:
Brolucizumab
Intravitreal injection
Aflibercept
Intravitreal injection

Locations

Country Name City State
Argentina Novartis Investigative Site Caba
Argentina Novartis Investigative Site Caba
Argentina Novartis Investigative Site Ciudad Autonoma de Bs As Buenos Aires
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Rosario Provincia De Santa Fe
Australia Novartis Investigative Site Adelaide South Australia
Australia Novartis Investigative Site Clayton Victoria
Australia Novartis Investigative Site Liverpool New South Wales
Australia Novartis Investigative Site Melbourne Victoria
Australia Novartis Investigative Site Nedlands Western Australia
Australia Novartis Investigative Site Parramatta New South Wales
Australia Novartis Investigative Site Sydney New South Wales
Australia Novartis Investigative Site Westmead New South Wales
Austria Novartis Investigative Site Graz
Austria Novartis Investigative Site Innsbruck
Austria Novartis Investigative Site Vienna
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Toronto Ontario
Canada Novartis Investigative Site Toronto Ontario
Colombia Novartis Investigative Site Bogota
Colombia Novartis Investigative Site Medellin Antioquia
Colombia Novartis Investigative Site Medellin Antioquia
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Jerusalem
Israel Novartis Investigative Site Kfar Saba
Israel Novartis Investigative Site Petach Tikva
Israel Novartis Investigative Site Rehovot
Israel Novartis Investigative Site Tel Aviv
Italy Novartis Investigative Site Catania CT
Italy Novartis Investigative Site Chieti CH
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Padova PD
Italy Novartis Investigative Site Roma RM
Japan Novartis Investigative Site Amagasaki city Hyogo
Japan Novartis Investigative Site Chiyoda-ku Tokyo
Japan Novartis Investigative Site Hachioji-city Tokyo
Japan Novartis Investigative Site Ishioka Ibaraki
Japan Novartis Investigative Site Kagoshima city Kagoshima
Japan Novartis Investigative Site Kumamoto
Japan Novartis Investigative Site Kurume-city Fukuoka
Japan Novartis Investigative Site Matsumoto-city Nagano
Japan Novartis Investigative Site Nagoya Aichi
Japan Novartis Investigative Site Nagoya Aichi
Japan Novartis Investigative Site Nagoya Aichi
Japan Novartis Investigative Site Nagoya-city Aichi
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Saitama-shi Saitama
Japan Novartis Investigative Site Shimotsuke Tochigi
Japan Novartis Investigative Site Shinjuku ku Tokyo
Japan Novartis Investigative Site Taito-ku Tokyo
Japan Novartis Investigative Site Tsuchiura Ibaragi
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Rotterdam
Netherlands Novartis Investigative Site Tilburg
Portugal Novartis Investigative Site Coimbra
Portugal Novartis Investigative Site Coimbra
Portugal Novartis Investigative Site Leiria
Portugal Novartis Investigative Site Porto
Portugal Novartis Investigative Site Porto
Portugal Novartis Investigative Site Santa Maria da Feira
Portugal Novartis Investigative Site Vila Franca de Xira
Puerto Rico Novartis Investigative Site Arecibo
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Sant Cugat Catalunya
Spain Novartis Investigative Site Valencia Comunidad Valenciana
Spain Novartis Investigative Site Valladolid Castilla Y Leon
Spain Novartis Investigative Site Zaragoza
United Kingdom Novartis Investigative Site Birmingham
United Kingdom Novartis Investigative Site Frimley Surrey
United Kingdom Novartis Investigative Site Hull
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Nottingham
United States Novartis Investigative Site 'Aiea Hawaii
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Bellaire Texas
United States Novartis Investigative Site Beverly Hills California
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Cleveland Ohio
United States Novartis Investigative Site Cleveland Ohio
United States Novartis Investigative Site Colorado Springs Colorado
United States Novartis Investigative Site Danbury Connecticut
United States Novartis Investigative Site Harlingen Texas
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Indianapolis Indiana
United States Novartis Investigative Site Kingston Pennsylvania
United States Novartis Investigative Site La Jolla California
United States Novartis Investigative Site Leawood Kansas
United States Novartis Investigative Site Lenexa Kansas
United States Novartis Investigative Site Madison Wisconsin
United States Novartis Investigative Site Memphis Tennessee
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site Mountain View California
United States Novartis Investigative Site Nashville Tennessee
United States Novartis Investigative Site New Albany Indiana
United States Novartis Investigative Site Paducah Kentucky
United States Novartis Investigative Site Pensacola Florida
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Phoenix Arizona
United States Novartis Investigative Site Reno Nevada
United States Novartis Investigative Site San Antonio Texas
United States Novartis Investigative Site Santa Barbara California
United States Novartis Investigative Site Silverdale Washington
United States Novartis Investigative Site Spokane Washington
United States Novartis Investigative Site Springfield Massachusetts
United States Novartis Investigative Site Stoneham Massachusetts
United States Novartis Investigative Site Stuart Florida
United States Novartis Investigative Site Tyler Texas
United States Novartis Investigative Site Urbana Illinois
United States Novartis Investigative Site Wheaton Illinois

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Canada,  Colombia,  Israel,  Italy,  Japan,  Netherlands,  Portugal,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included.
Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Baseline, Week 52
Secondary Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52 BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included.
Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Baseline and Week 40 through Week 52 (average)
Secondary Patients Maintained at q12w - Probability of Maintaining on q12w Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen [every 12 weeks (q12w)]. This outcome measure is pre-specified for brolucizumab treatment arms only. Baseline (Week 0), Weeks 32, 36 and 48
Secondary Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen [every 8 weeks (q8w)]. This outcome measure is pre-specified for brolucizumab treatment arms only. Weeks 36 and 48
Secondary Change From Baseline in BCVA at Each Visit up to Week 52 BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included.
Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Secondary BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF) Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts.
LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Baseline, and Week 88 through Week 100 (average)
Secondary Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w This outcome measure is pre-specified for brolucizumab treatment arms only Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96
Secondary Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w This outcome measure is pre-specified for brolucizumab treatment arms only Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96
Secondary Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Baseline up to week 52
Secondary Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF) Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Baseline, and Week 88 through Week 100 (average)
Secondary Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit Baseline up to Week 52 and Week 100
Secondary Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit Baseline, up to Week 52 and Week 100
Secondary Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit Baseline, up to Week 52 and Week 100
Secondary Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52 Assessed by angiography. Week 52
Secondary Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100 Assessed by angiography. Week 100
Secondary Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. Baseline, Weeks 28, 52, 76, 100
Secondary Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
estimates represent the % of participants who were estimated to have a ">=2-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (<=4, =5), age categories (<65, =65 years) and treatment as fixed effect factors.
Abbreviation: Proportion Estimates = P.E.
Baseline, Weeks 28, 52, 76, 100
Secondary Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. Baseline, Weeks 28, 52, 76, 100
Secondary Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
estimates represent the % of participants who were estimated to have a ">=3-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (<=4, =5), age categories (<65, =65 years) and treatment as fixed effect factors.
Abbreviation: Proportion Estimates = P.E.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Baseline, Weeks 28, 52, 76, 100
Secondary Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
Secondary Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
See also
  Status Clinical Trial Phase
Completed NCT03953807 - A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated Phase 4
Completed NCT03622580 - A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE) Phase 3
Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Active, not recruiting NCT04108156 - This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Withdrawn NCT03629210 - Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema Phase 2
Withdrawn NCT02842541 - Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema Phase 1
Completed NCT02221453 - Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide Phase 2
Completed NCT02556723 - Intravitreal Injections of Ziv-aflibercept for Macular Diseases N/A
Completed NCT02979665 - Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
Completed NCT02000102 - Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab N/A
Completed NCT02088229 - Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema N/A
Terminated NCT00779142 - Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies N/A
Completed NCT01171976 - Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus Phase 3
Completed NCT00989989 - Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema Phase 3
Completed NCT00683176 - Effect of Choline Fenofibrate (SLV348) on Macular Edema Phase 2
Terminated NCT00768040 - Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema Phase 2
Completed NCT01259609 - Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy N/A