Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO) (COMRADE-B)

August 4, 2014 updated by: Novartis Pharmaceuticals

A 6-month Multicenter, Randomized, Double-masked Phase IIIb-study Comparing the Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Branch Retinal Vein Occlusion (BRVO)

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Praha 10, Czech Republic, 100 34
        • Novartis Investigative Site
  • Germany
      • Augsburg, Germany, 85155
        • Novartis Investigative Site
      • Bad Rothenfelde, Germany, 49215
        • Novartis Investigative Site
      • Berlin, Germany, 10713
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Bochum, Germany, 44791
        • Novartis Investigative Site
      • Bonn, Germany, 53127
        • Novartis Investigative Site
      • Bremen, Germany, 28209
        • Novartis Investigative Site
      • Chemnitz, Germany, 09116
        • Novartis Investigative Site
      • Darmstadt, Germany, 64298
        • Novartis Investigative Site
      • Dresden, Germany, 01257
        • Novartis Investigative Site
      • Duesseldorf, Germany, 40225
        • Novartis Investigative Site
      • Düsseldorf, Germany, 40212
        • Novartis Investigative Site
      • Frankfurt, Germany, 60318
        • Novartis Investigative Site
      • Freiburg i. Br, Germany, 79106
        • Novartis Investigative Site
      • Glauchau, Germany, 08371
        • Novartis Investigative Site
      • Göttingen, Germany, 37075
        • Novartis Investigative Site
      • Hagen, Germany, 58097
        • Novartis Investigative Site
      • Halle, Germany, 06114
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Hamburg, Germany, 22417
        • Novartis Investigative Site
      • Homburg, Germany, 66421
        • Novartis Investigative Site
      • Ingolstadt, Germany, 85049
        • Novartis Investigative Site
      • Karlsruhe, Germany, 76133
        • Novartis Investigative Site
      • Karlsruhe, Germany, 76199
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Novartis Investigative Site
      • Koeln, Germany, 50935
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Ludwigshafen, Germany, 67063
        • Novartis Investigative Site
      • Marburg, Germany, 35039
        • Novartis Investigative Site
      • Minden, Germany, 32427
        • Novartis Investigative Site
      • Muelheim, Germany, 45468
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
      • Muenster, Germany, 48145
        • Novartis Investigative Site
      • Munich, Germany, 80336
        • Novartis Investigative Site
      • München, Germany, 81675
        • Novartis Investigative Site
      • Recklinghausen, Germany, 45657
        • Novartis Investigative Site
      • Regensburg, Germany, 93042
        • Novartis Investigative Site
      • Sulzbach, Germany, 66280
        • Novartis Investigative Site
      • Tübingen, Germany, 72076
        • Novartis Investigative Site
      • Ulm, Germany, 89075
        • Novartis Investigative Site
      • Wolfsburg, Germany, 38442
        • Novartis Investigative Site
      • Würzburg, Germany, 97080
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1083
        • Novartis Investigative Site
      • Debrecen, Hungary, 4004
        • Novartis Investigative Site
      • Szeged, Hungary, H-6720
        • Novartis Investigative Site
  • Poland
      • Bydgoszcz, Poland
        • Novartis Investigative Site
      • Bytom, Poland, 41-902
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B152WB
        • Novartis Investigative Site
      • Birmingham, United Kingdom, B18 7QU
        • Novartis Investigative Site
      • Bradford, United Kingdom, BD9 6RJ
        • Novartis Investigative Site
      • Cheshire, United Kingdom, CW14QJ
        • Novartis Investigative Site
      • Colchester, United Kingdom, CO3 3NB
        • Novartis Investigative Site
      • Derby, United Kingdom, DE22 3NE
        • Novartis Investigative Site
      • Gloucester, United Kingdom, GL1 3NN
        • Novartis Investigative Site
      • Guildford, Surrey, United Kingdom, GU2 5XX
        • Novartis Investigative Site
      • Kent, United Kingdom, CT1 3NG
        • Novartis Investigative Site
      • Leeds, United Kingdom, LS9 7TF
        • Novartis Investigative Site
      • London, United Kingdom, SE1 7EH
        • Novartis Investigative Site
      • Manchester, United Kingdom, M13 9WH
        • Novartis Investigative Site
      • Middlesborough, United Kingdom, TS4 3BW
        • Novartis Investigative Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novartis Investigative Site
      • Portsmouth, United Kingdom, PO6 3LY
        • Novartis Investigative Site
      • Rugby, United Kingdom, CV22 5PX
        • Novartis Investigative Site
      • Westcliff-on-Sea, United Kingdom, SS0 0RY
        • Novartis Investigative Site
      • York, United Kingdom, YO31 8HE
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with visual impairment due to macular edema following BRVO
  • Diagnosis of BRVO 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Drug: Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split
Sham Comparator: Dexamethasone
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Other: Dexamethasone Implant
Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.
Other: Sham injection
Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline
Time Frame: Baseline, month 6
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
Baseline, month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6
Time Frame: Baseline, 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
Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment
Time Frame: Baseline, 6 month
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 percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline
Baseline, 6 month
Time to Achieve a Significant Improvement ≥ 15 Letters
Time Frame: Baseline, month 6
The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts
Baseline, month 6
Change Over Time in BCVA
Time Frame: baseline, 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
Change Over Time of the Central Retinal Thickness (CRT)
Time Frame: Baseline, month 6
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
Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires
Time Frame: Baseline, month 6
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
Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires
Time Frame: Baseline, month 6
SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health
Baseline, month 6
Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires
Time Frame: Baseline, month 6
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
Rate of the Internal Ocular Pressure (IOP)
Time Frame: Baseline, month 6
The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.
Baseline, month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 15, 2011

First Posted (Estimate)

July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002EDE17
  • 2011-001019-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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