Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.

Conditions

• Choroidal Neovascularization (CNV)

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab — DRUG
  Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
• Sham control — OTHER
  The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.

Study Details

This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).

Key Dates

First listed

Apr 25, 2013

Start date

Sep 30, 2013

Status verified

Aug 2016

Primary completion

Nov 30, 2015

Completion

Nov 30, 2015

Study Design

Enrollment

183 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ranibizumab
  A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
• Sham Comparator: Sham control
  Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.

Primary Outcome Measure

Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 [ Time Frame: Baseline, Month 2 ]