Phase 3
Completed N=252
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)
Source: ClinicalTrials.gov NCT01976312 ↗Enrolled (actual)
252
Serious AEs
6.8%
Results posted
Apr 2017
Primary outcomePrimary: Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 — 11.3; -2.7 Letters — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
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 | — |
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. Informational only — not medical advice.