Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Conditions

• Pathological Myopia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab — DRUG
  0.5 mg ranibizumab intravitreal injection
• Verteporfin PDT — DRUG
  Verteporfin (6 mg/m2) intravenous infusion
• Sham Ranibizumab — DRUG
  Empty vial to mimic the intravitreal injection
• Sham verteporfin PDT — DRUG
  Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).

Study Details

This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

Key Dates

Start date

Oct 31, 2010

Status verified

Jan 2014

Primary completion

Aug 31, 2012

Completion

Aug 31, 2012

Study Design

Enrollment

277 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ranibizumab driven by disease activity
  Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
• Experimental: Ranibizumab driven by stabilization criteria
  Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity
• Active Comparator: Verteporfin PDT
  Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.

Primary Outcome Measure

Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye [ Time Frame: Baseline, Month 1 through Month 3 ]