Photodynamic and Pharmacologic Treatment of CNV

Macular Degeneration Clinical Trial

— PBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570193
• Other study ID #: PBS-100-388
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 6, 2007
• Last updated: July 6, 2012
• Start date: December 2006
• Est. completion date: June 2011

Study information

• Verified date: July 2012
• Source: Mid-Atlantic Retina Consultations, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All previously untreated CNV secondary to MD

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mid-Atlantic Retina Consultations, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual change		18 months
Secondary	Frequency of treatment		18 months