Phase 3
N=244
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)
Visual Impairment · Macular Edema · Branch Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01396057 ↗Enrolled (actual)
244
Serious AEs
6.6%
Results posted
Jul 2014
Primary outcome: Primary: Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline — 14.9; 10.1 Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranibizumab (Drug); Dexamethasone Implant (Other); Sham injection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline |
14.9; 10.1 | — |
| SECONDARY Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6 |
16.18; 8.10 | — |
| SECONDARY Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment |
77; 44; 0; 6; 97; 63 | — |
| SECONDARY Time to Achieve a Significant Improvement ≥ 15 Letters |
63; 64 | — |
| SECONDARY Change Over Time in BCVA |
10.35; 10.44; 13.84; 12.62; 15.52; 9.16 | — |
| SECONDARY Change Over Time of the Central Retinal Thickness (CRT) |
-230.6; -112.3 | — |
| SECONDARY Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires |
7.2; 2.8 | — |
| SECONDARY Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires |
-1.1; -0.4; 3.3; 0.2 | — |
| SECONDARY Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires |
0.7; -2.4 | — |
| SECONDARY Rate of the Internal Ocular Pressure (IOP) |
79; 106 | — |
Summary
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.
Eligibility Criteria
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) 10 letters on BCVA between Screening and Baseline
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01396057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.