Back to resultsDouble-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration
Primary Purpose
Macular Degeneration
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Photrex (rostaporfin)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Macular Degeneration, AMD, Visual Acuity
Eligibility Criteria
Inclusion Criteria: Patients with age greater than or equal to 50 years with at least one subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography.
Sites / Locations
- Multiple InvestigatorsRecruiting
- Multiple InvestigatorsRecruiting
- Multiple InvestigatorsRecruiting
- Multiple InvestigatorsRecruiting
Outcomes
Primary Outcome Measures
Visual Acuity
Secondary Outcome Measures
Angiographic changes
Full Information
NCT ID
NCT00157976
First Posted
September 8, 2005
Last Updated
November 29, 2005
Sponsor
Miravant Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00157976
Brief Title
Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration
Official Title
A Phase III Randomized, Multicenter, Multinational, Double-Masked, Placebo-Controlled Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Classic and Occult Subfoveal Choroidal Neovascularization Associated With AMD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Miravant Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Macular Degeneration, AMD, Visual Acuity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
660 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Photrex (rostaporfin)
Primary Outcome Measure Information:
Title
Visual Acuity
Secondary Outcome Measure Information:
Title
Angiographic changes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with age greater than or equal to 50 years with at least one subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miravant Pharmaceuticals
Phone
1-800-685-2959
Email
ctinfo@miravant.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy J. Snyder, PhD
Organizational Affiliation
Miravant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Multiple Investigators
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiple Investigators
City
Brno-Bohunice, Olomouc, Praha
Country
Czech Republic
Individual Site Status
Recruiting
Facility Name
Multiple Investigators
City
Warsaw, Bydgoszcz, Lubin
Country
Poland
Individual Site Status
Recruiting
Facility Name
Multiple Investigators
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration
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