Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Conditions

• Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab 0.5mg — DRUG
  0.5 mg ranibizumab (intravitreal injections)
• Ranibizumab 0.5 mg — DRUG
  0.5 mg ranibizumab (intravitreal injections)
• Verteporfin PDT — DRUG
  Verteporfin for intravenous injection delivered by intravenous infusion followed by the light application

Study Details

This study was 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 secondary to pathologic myopia (PM)

Key Dates

Start date

Sep 11, 2013

Status verified

Mar 2019

Primary completion

Sep 14, 2016

Completion

Sep 14, 2016

Study Design

Enrollment

457 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group I
  0.5 mg ranibizumab driven by visual acuity stability criteria
• Experimental: Group II
  0.5 mg ranibizumab driven by disease activity criteria
• Active Comparator: Group III
  verteporfin PDT

Primary Outcome Measure

Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 [ Time Frame: From Baseline to Month 3 ]