A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Central Retinal Vein Occlusion (CRVO) [Camellia]

Novartis Pharmaceuticals1 site in 1 country252 target enrollmentNovember 12, 2013

ConditionsCentral Retinal Vein Occlusion

InterventionsRanibizumab 0.5 mg Sham injection

DrugsRanibizumab 0.5 mg

Overview

Phase: Phase 3
Intervention: Ranibizumab 0.5 mg
Conditions: Central Retinal Vein Occlusion
Sponsor: Novartis Pharmaceuticals
Enrollment: 252
Locations: 1
Primary Endpoint: Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

November 12, 2013

End Date

March 14, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

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

Arms & Interventions

Ranibizumab 0.5 mg

PRN intravitreal injection

Intervention: Ranibizumab 0.5 mg

Sham injection

As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections

Intervention: Sham injection

Outcomes

Primary Outcomes

Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3

Time Frame: Baseline, 3 Months

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline.

Secondary Outcomes

Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time(Month 1 to month 12)
Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time(Month 1 to 12 months)
The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline(Month 3,6 and 12)
Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12(Baseline, 12 months)
Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time(Month 1 to 12 months)
Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time(Month 1 to month 12)