Phase 3
N=252
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)
Central Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01976312 ↗Enrolled (actual)
252
Serious AEs
6.8%
Results posted
Apr 2017
Primary outcome: Primary: Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 — 11.3; -2.7 Letters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sham injection (Other); Ranibizumab 0.5 mg (Drug)
- 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 Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 |
11.3; -2.7 | <0.001 sig |
| SECONDARY Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 |
12.4; 3.2 | — |
| SECONDARY Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time |
9.6; -0.9; 11.6; -3.4; 12.6; -3.8 | — |
| SECONDARY Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time |
-393.7; -13.3; -412.6; -7.9; -433.3; -84.4 | — |
| SECONDARY Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time |
141; 17; 94; 6; 56; 2 | — |
| SECONDARY Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time |
185; 57; 182; 53; 182; 51 | — |
| SECONDARY The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline |
4.4; 0.1; 6.7; 2.9; 8.2; 3.2 | — |
Summary
Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO
Eligibility Criteria
Inclusion Criteria for study and fellow eye:
- Patients with visual impairment secondary to central retinal vein occlusion (CRVO) with a BCVA between 24 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 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 3 and 4 months respectively
Data sourced from ClinicalTrials.gov (NCT01976312). 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.