Overview

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

Status:
Completed
Trial end date:
2016-09-14
Target enrollment:
0
Participant gender:
All
Summary
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)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Ranibizumab
Verteporfin
Criteria
Inclusion Criteria:

- Visual impairment due to CNV secondary to PM.

- Best corrected visual acuity in the study eye > 24 and < 78 ETDRS letters.

- High myopia (> -6D),

- anterio-posterior elongation > 26 mm; posterior changes compatible with the pathologic
myopia.

- Either CNV locations in the study eye: subfoveal, juxtafoveal, extrafoveal.

Exclusion Criteria:

- Some preexisting eye disorders or systemic diseases;-Blood pressure > 150/90 mmHg

- Prior focal/grid laser to the macular area -History of treatment with any anti-VEGF or
verteporfin PDT in the study eye

- Intravitreal treatment with corticosteroids or intraocular surgery within last 3
months in the study eye