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NCT00157976 Clinical Trial

Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00157976
Other study ID # MRVT-920101-OPH005
Secondary ID
Status Recruiting
Phase Phase 3
First received September 8, 2005
Last updated November 29, 2005
Start date September 2005

Study information
Verified date November 2005
Source Miravant Pharmaceuticals
Contact Miravant Pharmaceuticals
Phone 1-800-685-2959
Email ctinfo@miravant.com
Is FDA regulated No
Health authority United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug Control (SUKL)Poland: National Medicines AgencyRomania: National Medicines Agency
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 660
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Photrex (rostaporfin)

Locations
Country Name City State
Bulgaria Multiple Investigators Sofia
Czech Republic Multiple Investigators Brno-Bohunice, Olomouc, Praha
Poland Multiple Investigators Warsaw, Bydgoszcz, Lubin
Romania Multiple Investigators Bucharest

Sponsors (1)
Lead Sponsor Collaborator
Miravant Pharmaceuticals

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Poland,  Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Acuity
Secondary Angiographic changes
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