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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Miravant Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Miravant Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00157976
First received: September 8, 2005
Last updated: November 29, 2005
Last verified: November 2005
  Purpose

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 Intervention Phase
Macular Degeneration
Drug: Photrex (rostaporfin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Miravant Pharmaceuticals:

Primary Outcome Measures:
  • Visual Acuity

Secondary Outcome Measures:
  • Angiographic changes

Estimated Enrollment: 660
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157976     History of Changes
Other Study ID Numbers: MRVT-920101-OPH005
Study First Received: September 8, 2005
Last Updated: November 29, 2005
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control (SUKL)
Poland: National Medicines Agency
Romania: National Medicines Agency

Keywords provided by Miravant Pharmaceuticals:
Macular Degeneration
AMD
Visual Acuity

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

ClinicalTrials.gov processed this record on November 27, 2014