Photodynamic and Pharmacologic Treatment of CNV

Mid-Atlantic Retina Consultations, Inc.41 enrolled

Overview

The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Choroidal Neovascularization Macular Degeneration

Interventions

verteporfin (Visudyne)DRUG

Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1

ranibizumab (Lucentis)DRUG

ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33\&37 per study protocol

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All previously untreated CNV secondary to MD

Outcomes

Primary Outcomes

Visual change

Time frame: 18 months

Secondary Outcomes

Frequency of treatment

Time frame: 18 months

Data from ClinicalTrials.gov

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