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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01396083
Other study ID # CRFB002EDE18
Secondary ID 2011-001020-38
Status Completed
Phase Phase 3
First received July 14, 2011
Last updated September 21, 2016
Start date August 2011
Est. completion date January 2014

Study information

Verified date September 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.


Recruitment information / eligibility

Status Completed
Enrollment 243
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients diagnosed with visual impairment due to macular edema following CRVO

- Diagnosis of CRVO at maximum 6 months prior to Screening

- BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Exclusion Criteria:

- Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs

- Central retinal thickness (CRT) < 250 µm in the study eye

- Prior episode of RVO in the study eye

- Active formation of new vessels in the study eye

- Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline

- IOP = 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment

- Improvement of > 10 letters on BCVA between Screening and Baseline

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Ranibizumab

Dexamethasone implant and sham injections


Locations

Country Name City State
Germany Novartis Investigative Site Augsburg
Germany Novartis Investigative Site Bad Rothenfelde
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Bonn
Germany Novartis Investigative Site Bremen
Germany Novartis Investigative Site Chemnitz
Germany Novartis Investigative Site Darmstadt
Germany Novartis Investigative Site Dortmund
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Duesseldorf
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Freiburg i. Br
Germany Novartis Investigative Site Glauchau
Germany Novartis Investigative Site Göttingen
Germany Novartis Investigative Site Hagen
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Homburg
Germany Novartis Investigative Site Ingolstadt
Germany Novartis Investigative Site Karlsruhe
Germany Novartis Investigative Site Karlsruhe
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Koeln
Germany Novartis Investigative Site Lauterbach
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Ludwigshafen
Germany Novartis Investigative Site Minden
Germany Novartis Investigative Site Muelheim
Germany Novartis Investigative Site Muenster
Germany Novartis Investigative Site Muenster
Germany Novartis Investigative Site München
Germany Novartis Investigative Site München
Germany Novartis Investigative Site Nuernberg
Germany Novartis Investigative Site Recklinghausen
Germany Novartis Investigative Site Regensburg
Germany Novartis Investigative Site Sulzbach
Germany Novartis Investigative Site Tübingen
Germany Novartis Investigative Site Ulm
Germany Novartis Investigative Site Wolfsburg
Germany Novartis Investigative Site Würzburg
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Szeged
Poland Novartis Investigative Site Bydgoszcz
Poland Novartis Investigative Site Bytom
United Kingdom Novartis Investigative Site Birmingham
United Kingdom Novartis Investigative Site Birmingham
United Kingdom Novartis Investigative Site Bradford
United Kingdom Novartis Investigative Site Cheshire
United Kingdom Novartis Investigative Site Colchester
United Kingdom Novartis Investigative Site Derby
United Kingdom Novartis Investigative Site Gloucester
United Kingdom Novartis Investigative Site Guildford, Surrey
United Kingdom Novartis Investigative Site Kent
United Kingdom Novartis Investigative Site Leeds
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Manchester
United Kingdom Novartis Investigative Site Middlesborough
United Kingdom Novartis Investigative Site Nottingham
United Kingdom Novartis Investigative Site Portsmouth
United Kingdom Novartis Investigative Site Rugby
United Kingdom Novartis Investigative Site Westcliff-on-Sea
United Kingdom Novartis Investigative Site York

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Hungary,  Poland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Average BCVA Change From Month 1 Through Month 6 to Baseline the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity Baseline, month 6 No
Secondary Mean BCVA Change at Month 6 The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors Baseline, month 6 No
Secondary Number of Patients Gaining / Losing = 15 / 10 / 5 Letters BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline Baseline, 6 month No
Secondary Time to Achieve a Significant Improvement = 15 Letters The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts Baseline, month 6 No
Secondary Change Over Time in BCVA The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors Baseline, month 6 No
Secondary Change Over Time of the Central Retinal Thickness (CRT) Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation Baseline, month 6 No
Secondary Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function Baseline, month 6 No
Secondary Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health Baseline, month 6 No
Secondary Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state. Baseline, month 6 No
Secondary Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With =10% Increase in IOP Compared to Baseline The proportion of patients with = 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit. Baseline, month 6 No
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