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

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ClinicalTrials.gov Identifier: NCT00157976
Recruitment Status : Unknown
Verified November 2005 by Miravant Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : December 1, 2005
Sponsor:
Information provided by:
Miravant Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Photrex (rostaporfin) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Visual Acuity

Secondary Outcome Measures :
  1. Angiographic changes


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157976


Contacts
Contact: Miravant Pharmaceuticals 1-800-685-2959 ctinfo@miravant.com

Locations
Bulgaria
Multiple Investigators Recruiting
Sofia, Bulgaria
Czech Republic
Multiple Investigators Recruiting
Brno-Bohunice, Olomouc, Praha, Czech Republic
Poland
Multiple Investigators Recruiting
Warsaw, Bydgoszcz, Lubin, Poland
Romania
Multiple Investigators Recruiting
Bucharest, Romania
Sponsors and Collaborators
Miravant Pharmaceuticals
Investigators
Study Director: Wendy J. Snyder, PhD Miravant Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00157976     History of Changes
Other Study ID Numbers: MRVT-920101-OPH005
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 1, 2005
Last Verified: November 2005

Keywords provided by Miravant Pharmaceuticals:
Macular Degeneration
AMD
Visual Acuity

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes