Photodynamic and Pharmacologic Treatment of CNV

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Choroidal Neovascularization Choroid Diseases Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All previously untreated CNV secondary to MD

Treatment and study plan

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

Other names: Visudyne = verteporfin, Lucentis = ranibizumab

Ranibizumab (Lucentis)

Drug

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

Other names: Lucentis = ranibizumab

Primary outcomes

Visual change

Time frame: 18 months

Secondary outcomes

Frequency of treatment

Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Mid-Atlantic Retina Consultations, Inc.

Other

Registry information

Official study title

Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)

Acronym: PBS

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Dec 10, 2007
Registry last updated: Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed