Photodynamic and Pharmacologic Treatment of CNV

Phase 1

Completed

• Conditions: Choroidal Neovascularization; Macular Degeneration
• Interventions: Drug: verteporfin (Visudyne); Drug: ranibizumab (Lucentis)

• Registration Number: NCT00570193
• Lead Sponsor: Mid-Atlantic Retina Consultations, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• All previously untreated CNV secondary to MD

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	verteporfin (Visudyne)	Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)
II	ranibizumab (Lucentis)	Treatment with ranibizumab (Lucentis)

Primary Outcome Measures

Name	Time	Method
Visual change	18 months

Secondary Outcome Measures

Name	Time	Method
Frequency of treatment	18 months