A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion

Conditions

• Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab — DRUG
  Liquid ranibizumab (10 mg/ml) was supplied in a sterile solution in single-use vials.

Study Details

This was a Phase IV multicenter, randomized, open-label study, with masking of the vision examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).

Key Dates

First listed

Jan 14, 2011

Start date

Feb 28, 2011

Status verified

Mar 2014

Primary completion

Oct 31, 2012

Completion

Oct 31, 2012

Study Design

Enrollment

202 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ranibizumab 0.5 mg monthly - randomized subjects
  Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
• Experimental: Ranibizumab 0.5 mg PRN - randomized subjects
  Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm. No injection was given at the randomization visit. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
• Experimental: Ranibizumab 0.5 mg monthly - non-randomized subjects
  Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.

Primary Outcome Measure

Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15 [ Time Frame: Baseline to Month 15 ]

Locations (42)

Related Studies

• A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
  PHASE2 · Recruiting · Boehringer Ingelheim · Arcadia, California