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

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)

Timeline

Start

2013-09-11

Primary completion

2016-09-14

Completion

2016-09-14

Outcome

Met primary endpoint

registry MEAN Group I: Average Month 1 to Month 3: 63.1 (Standard Deviation 12.80) ETDRS letters NCT01922102 ↗

registry analysis (superiority or other test); Group I vs Group III; p <0.001; Mean Difference (Net) 5.2 (95% CI 3.3 to 7.1) NCT01922102 ↗

registry analysis (superiority or other test); Group II vs Group III; p <0.001; Mean Difference (Net) 5.6 (95% CI 3.5 to 7.6) NCT01922102 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranibizumab	Monoclonal antibody	0.5 mg	Intravitreal
Comparator	Verteporfin	Other / unclassified	—	Intravenous

Indications