Phase 3
Completed N=283
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)
Macular Edema Secondary to Branch Retinal Vein Occlusion
Source: ClinicalTrials.gov NCT01976338 ↗
Enrolled (actual)
283
Serious AEs
6.7%
Results posted
May 2017
Primary outcomePrimary: Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6 — 12.5; 5.0 Letters — p=<0.001
◆ Published Evidence
Established
23citations · ~4 / year
Efficacy and Safety of Ranibizumab in Asian Patients with Branch Retinal Vein Occlusion: Results from the Randomized BLOSSOM Study.
Summary
Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO
Linked Publications
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Efficacy and Safety of Ranibizumab in Asian Patients with Branch Retinal Vein Occlusion: Results from the Randomized BLOSSOM Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6 |
12.5; 5.0 | <0.001 sig |
| SECONDARY Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12 |
14.0; 7.7 | — |
| SECONDARY Best Corrected Visual Acuity (BCVA) Change Over Time |
9.5; 1.7; 11.7; 3.7; 12.9; 5.1 | — |
| SECONDARY Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time |
139; 33; 86; 12; 43; 3 | — |
| SECONDARY Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye |
188; 89; 189; 90; 189; 88 | — |
| SECONDARY Change in Central-Sub-Field- Thickness (CSFT) Over Time |
-261.1; -42.4; -274.8; -93.1; -282.2; -155.3 | — |
| SECONDARY Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time |
-0.400; -0.026; -0.356; -0.055; -0.391; -.0208 | — |
| SECONDARY Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time |
-1.869; 0.111; -1.642; -0.078; -1.732; -0.823 | — |
| SECONDARY Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time |
-4.994; -0.600; -4.654; -0.836; -5.078; -2.797 | — |
| SECONDARY Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12 |
5.8; -1.1; 7.7; 0.1; 9.6; 3.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a BCVA between 19 and 73 letters in one eye and at least 35 letters in the other eye.
Exclusion Criteria
- Pregnant or nursing women or women of child bearing potential without unless using an effective contraception
- Stroke or myocard infarction within 3 months prior to study
- History of malignancy within the past 5 years
- Uncontrolled hypertension
- Active infection or inflammation in any eye
- use of corticosteroids for at least 30 days in the last 6 months
- treatment with anti-angiogenic drugs in any eye within last 3 months
- Panretinal or focal/drid laser photocoagulation within the last few months
Data sourced from ClinicalTrials.gov (NCT01976338) and the linked publication. 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. Informational only — not medical advice.