MSI-1256F (Squalamine Lactate) in Combination With Verteporfin in Patients With "Wet" Age-Related Macular Degeneration (AMD) - Full Text View

Sponsored by:	Genaera Corporation
Information provided by:	Genaera Corporation
ClinicalTrials.gov Identifier:	NCT00094120

Purpose

Age-Related Macular Degeneration (AMD) is a degenerative disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula.

Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine when administered with verteporfin therapy in patients with "wet" AMD.

Condition	Intervention	Phase
Macular Degeneration	Drug: MSI-1256F (Squalamine Lactate)	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Lactic acid Ammonium lactate Verteporfin Squalamine Squalamine lactate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of MSI-1256F (Squalamine Lactate) in Combination With Verteporfin in Patients With "Wet" Age-Related Macular Degeneration (AMD)

Further study details as provided by Genaera Corporation:

Estimated Enrollment:	60
Study Start Date:	October 2004
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a diagnosis of "wet" age-related macular degeneration

Exclusion Criteria:

Prior treatment for "wet" age-related macular degeneration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094120

Locations

United States, Pennsylvania
Genaera Corporation
Plymouth Meeting, Pennsylvania, United States, 19462

Sponsors and Collaborators

Genaera Corporation

More Information

Study ID Numbers:	MSI-1256F-208
Study First Received:	October 11, 2004
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00094120
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genaera Corporation:

Age-Related Macular Degeneration - Wet Type

Study placed in the following topic categories:

Squalamine
Eye Diseases
Verteporfin
Retinal Degeneration

Macular Degeneration
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Protective Agents
Angiogenesis Inhibitors
Pharmacologic Actions

Anti-Bacterial Agents
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009