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

Conditions

• Central Retinal Vein Occlusion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sham injection — OTHER
  Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.
• Ranibizumab 0.5 mg — DRUG
  Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only

Study Details

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

Key Dates

First listed

Nov 5, 2013

Start date

Nov 12, 2013

Status verified

Apr 2017

Primary completion

Mar 14, 2016

Completion

Mar 14, 2016

Study Design

Enrollment

252 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ranibizumab 0.5 mg
  PRN intravitreal injection
• Sham Comparator: Sham injection
  As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections

Primary Outcome Measure

Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 [ Time Frame: Baseline, 3 Months ]