Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Macular Degeneration Clinical Trial

Official title:

An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of 2 mg Aflibercept Administered by Intravitreal Injections Using Two Different Treatment Regimens to Subjects With Neovascular Age-related Macular Degeneration (nAMD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540954
• Other study ID #: 16598
• Secondary ID: 2013-000120-33
• Status: Completed
• Phase: Phase 3
• Start date: September 29, 2015
• Est. completion date: June 4, 2020

Study information

• Verified date: June 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

Description:

330 Patients who have completed at least one year of treatment with aflibercept will be randomized to two different aflibercept regimens and followed for 76 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: June 4, 2020
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years and older

Eligibility

Inclusion Criteria:

• The following criteria must have been met at the initial start of aflibercept

treatment (i.e. start of aflibercept treatment at least 1 year before this study):

• Subject had primary subfoveal choroidal neovascularization (CNV) lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea, as evidenced by fluorescein angiography/photography (FA/FP) of the study eye within 3 weeks before the initiation of aflibercept treatment.
• The area of CNV occupied at least 50% of the total lesion within 3 weeks before the initiation of aflibercept treatment.
• Documented best-corrected visual acuity (BCVA) was 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment.
• Men and women >= 51 years of age
• The subject's history of aflibercept treatment meets ALL of the following:
• Treatment in the study eye was initiated with three monthly (-1 week/+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed
• Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks

Exclusion Criteria:

• Any prior or concomitant therapy with an investigational or approved agent to treat neovascular AMD in the study eye other than aflibercept.
• Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by fluorescein angiography (FA) in the study eye
• Subretinal hemorrhage that was:

1. 50% or more of the total lesion area, or

2. if the blood was under the fovea, and

3. the blood under the fovea was 1 or more disc areas in size in the study eye.

• Scar or fibrosis making up more than 50% of the total lesion in the study eye.
• Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
• Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
• Causes of CNV other than AMD in the study eye.

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
A dose of 2 mg aflibercept injected intravitreally

Locations

Country	Name	City	State
Canada	Clinique medicale de l'oeil de l'Estrie	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Lithuania,  Poland,  Portugal,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye	Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.	From baseline to Week 52
Secondary	Percentage of Participants Maintaining Vision in the Study Eye	A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.	At week 52
Secondary	Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye		At week 52
Secondary	Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	Retinal characteristic was evaluated using Optical coherence tomography (OCT).	From baseline to week 52
Secondary	Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye	Choroidal neovascularization measured by optical coherence tomography (OCT).	From baseline to week 52
Secondary	Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye		At week 52
Secondary	Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire	National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) total score ranges from 0 to 100, where 100 represents the best possible score and 0 represents the worst.	From baseline to week 52
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAE)		Started after the first application of aflibercept in the study and less than or equal to 30 days after the last dose of study drug over approximately 1.5 years

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