CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 457 enrolled
Drug / intervention
Ranibizumab 0.5mg +2 moredrug
Likely dose
Ranibizumab 0.5mgfrom 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/NCT01922102
NCT01922102Phase 3Completed

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

Novartis Pharmaceuticals·interventional·Posted Aug 14, 2013·Updated Jun 24, 2019

In Brief

A Phase 3 clinical trial evaluating Ranibizumab 0.5mg, Ranibizumab 0.5 mg, and 1 other intervention for Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM). Completed, enrolled 457 participants across 47 sites in 6 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, Hong Kong, India, Philippines, South Korea, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 14, 2013
Enrollment StartSep 11, 2013
Primary CompletionSep 14, 2016
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.9 years ago

Interventions

Ranibizumab 0.5mgdrug

0.5 mg ranibizumab (intravitreal injections)

Ranibizumab 0.5 mgdrug

0.5 mg ranibizumab (intravitreal injections)

Verteporfin PDTdrug

Verteporfin for intravenous injection delivered by intravenous infusion followed by the light application