Phase 3
N=283
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)
Macular Edema Secondary to Branch Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01976338 ↗Enrolled (actual)
283
Serious AEs
6.7%
Results posted
May 2017
Primary outcome: Primary: Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6 — 12.5; 5.0 Letters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranibizumab 0.5 mg (Drug); Sham injection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2016
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 | — |
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
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). 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.