Visudyne® in Occult (VIO)

Macular Degeneration Clinical Trial

Official title: A Randomized, Placebo-Controlled, Double-Masked, Multicenter, Phase III Study of the Effect of Visudyne Therapy in Occult With No Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD): Visudyne in Occult (VIO)

Status Completed

Clinical Trial Summary

The purpose of this study is to demonstrate that Visudyne therapy in patients who have occult with no classic subfoveal choroidal neovascularization (CNV) lesions will, with an acceptable safety profile, significantly reduce the risk of vision loss compared with placebo (sham treatment).

Clinical Trial Description

This is a randomized, placebo-controlled, double masked, multicenter, Phase III study. Patients will be stratified by study center and randomized to Visudyne therapy or placebo in a 2:1 ratio, respectively. Patients will receive either a single intravenous dose of Visudyne or placebo followed 15 minutes after the start of the infusion by light application. Follow-up visits will occur every three months (+/- 2 weeks) for the duration of the study. Re-treatment may be administered every three months (through the Month 21 visit) if evidence of CNV leakage is detected by fluorescein angiography (as judged by the Investigator).

At baseline and at each follow-up visit, patients will undergo the following assessments:

ophthalmic examination, best-corrected visual acuity, color fundus photography, and fluorescein angiography. Indocyanine green (ICG) angiography will be conducted at baseline, Month 12, and Month 24. Optical coherence tomography (OCT) will be done at baseline, Month 3, Month 6, Month 12, and Month 24. Adverse events and concomitant medications will be assessed throughout the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration

• NCT number: NCT00121407
• Study type: Interventional
• Source: QLT Inc.
• Status: Completed
• Phase: Phase 3
• Start date: March 2002
• Completion date: August 2005