Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)

Phase 3

Completed

• Conditions: Central Retinal Vein Occlusion
• Interventions: Drug: Ranibizumab 0.5 mg; Other: Sham injection

• Registration Number: NCT01976312
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-05
• Study Start: 2013-11-12
• Primary Completion: 2016-03-14
• Study Completion: 2016-03-14
• Results First Submitted: 2017-03-13
• Results First Submitted QC: 2017-03-13
• Status Verified: 2017-04
• Results First Posted: 2017-04-24
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab 0.5 mg	Ranibizumab 0.5 mg	PRN intravitreal injection
Sham injection	Sham injection	As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections

Primary Outcome Measures

Name	Time	Method
Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3	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 Outcome Measures

Name	Time	Method
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	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.
Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time	Month 1 to 12 months	Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
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	The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.
Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12	Baseline, 12 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 12 and compared to Baseline
Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time	Month 1 to 12 months	Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline
Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time	Month 1 to month 12	OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Ho Chi Minh City, Vietnam