MedTrace Logo

Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

NCT00492284 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2011-06-02

Study results available
· View outcomes & findings →

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.

Conditions

  • Choroidal Neovascularization
  • Macular Degeneration

Interventions

DRUG

verteporfin

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

DRUG

verteporfin

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

DRUG

ranibizumab

0.5 mg intravitreal injection

DRUG

dexamethasone

0.5 mg intravitreal injection

Sponsors & Collaborators

  • QLT Inc.

    lead INDUSTRY

Principal Investigators

  • Henry Hudson, MD · Retina Centers, PC

  • Allen Ho, MD · Retina Diagnostic & Treatment Associates, LLC

  • Andrew Strong, Ph.D · QLT Inc.

  • Oscar Cuzzani, MD · QLT Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-05-31
Completion
2010-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00492284 on ClinicalTrials.gov