Photodynamic and Pharmacologic Treatment of CNV (PBS)
Primary Purpose
Choroidal Neovascularization, Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
verteporfin (Visudyne)
ranibizumab (Lucentis)
Sponsored by
About this trial
This is an interventional treatment trial for Choroidal Neovascularization
Eligibility Criteria
Inclusion Criteria:
- All previously untreated CNV secondary to MD
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
I
II
Arm Description
Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)
Treatment with ranibizumab (Lucentis)
Outcomes
Primary Outcome Measures
Visual change
Secondary Outcome Measures
Frequency of treatment
Full Information
NCT ID
NCT00570193
First Posted
December 6, 2007
Last Updated
July 6, 2012
Sponsor
Mid-Atlantic Retina Consultations, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00570193
Brief Title
Photodynamic and Pharmacologic Treatment of CNV
Acronym
PBS
Official Title
Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mid-Atlantic Retina Consultations, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Arm Description
Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)
Arm Title
II
Arm Type
Experimental
Arm Description
Treatment with ranibizumab (Lucentis)
Intervention Type
Drug
Intervention Name(s)
verteporfin (Visudyne)
Other Intervention Name(s)
Visudyne = verteporfin, Lucentis = ranibizumab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ranibizumab (Lucentis)
Other Intervention Name(s)
Lucentis = ranibizumab
Intervention Description
ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33&37 per study protocol
Primary Outcome Measure Information:
Title
Visual change
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Frequency of treatment
Time Frame
18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All previously untreated CNV secondary to MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil M Jabbour, MD
Organizational Affiliation
Mid-Atlantic Retina Consultations
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Photodynamic and Pharmacologic Treatment of CNV
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