CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 162 enrolled
Drug / intervention
verteporfin +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/NCT00492284
NCT00492284Phase 2Completed

A Multicenter, Randomized, Single-masked Study Comparing Reduced-fluence Visudyne®-Lucentis® Combination Therapies and Lucentis® Monotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to AMD.

QLT Inc.·interventional·Posted Jun 27, 2007·Updated Jun 2, 2011

In Brief

A Phase 2 clinical trial evaluating verteporfin, ranibizumab, and 1 other intervention for Choroidal Neovascularization and Macular Degeneration. Completed, enrolled 162 participants across 26 sites in 2 countries.

Detailed Summary

The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis \[within 2 hours\] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy \[within 2 hours\]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2007
Enrollment StartJul 1, 2007
Primary CompletionMay 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.0 years ago

Interventions

verteporfindrug

Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)

verteporfindrug

Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)

ranibizumabdrug

0.5 mg intravitreal injection

dexamethasonedrug

0.5 mg intravitreal injection