Visudyne® in Occult (VIO)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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)|
- The primary efficacy variable is the patient responder rate. The patient responder rate has two definitions as described below:
- • The proportion of patients who lose less than 15 letters (<3 lines) of best-corrected visual acuity in the study eye from baseline
- • The proportion of patients who lose fewer than 30 letters (<6 lines) of best-corrected visual acuity in the study eye from baseline
- • The proportion of patients whose best-corrected visual acuity decreased to fewer than 34 letters (approximate Snellen equivalent of 20/200)
- • Change from baseline in visual acuity score
- • Cumulative proportion of patients who develop predominantly classic CNV in the study eye (identified by the Investigator and confirmed by a central reading center).
|Study Start Date:||March 2002|
|Estimated Study Completion Date:||August 2005|
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.