CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 277 enrolled
Drug / intervention
Ranibizumab +3 moredrug
Likely dose
Ranibizumab 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01217944
NCT01217944Phase 3Completed
CompareCT.gov

A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Novartis Pharmaceuticals·interventional·Posted Oct 8, 2010·Updated Feb 10, 2014

In Brief

A Phase 3 clinical trial evaluating Ranibizumab, Verteporfin PDT, and 2 other interventions for Pathological Myopia. Completed, enrolled 277 participants across 74 sites in 20 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPathological Myopia
CountriesAustria, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Latvia, Lithuania, Poland, Portugal, Singapore, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2010
Enrollment StartOct 1, 2010
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.7 years ago

Interventions

Ranibizumabdrug

0.5 mg ranibizumab intravitreal injection

Verteporfin PDTdrug

Verteporfin (6 mg/m2) intravenous infusion

Sham Ranibizumabdrug

Empty vial to mimic the intravitreal injection

Sham verteporfin PDTdrug

Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).