Conditions: Pathological Myopia
Keywords: Pathologic myopia PM choroidal neovascularization CNV ranibizumab verteporfin PDT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 277
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria arm 2: Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity arm 3: Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.

Interventions: intervention 1: Ranibizumab intervention 2: Verteporfin PDT intervention 3: Sham Ranibizumab intervention 4: Sham verteporfin PDT
Intervention descriptions: intervention 1: 0.5 mg ranibizumab intravitreal injection intervention 2: Verteporfin (6 mg/m2) intravenous infusion intervention 3: Empty vial to mimic the intravitreal injection intervention 4: Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).

Protocol document: