A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration

This study has been terminated.
Sponsor:
Information provided by:
Genaera Corporation
ClinicalTrials.gov Identifier:
NCT00139282
First received: August 29, 2005
Last updated: November 27, 2007
Last verified: November 2007
  Purpose

Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of 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 evaluate the safety and efficacy of Squalamine lactate in the treatment of AMD in patients, the exact number of which will be determined based on data from the sponsor's ongoing Phase 2 trials.

The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the control group.


Condition Intervention Phase
"Wet" Age-Related Macular Degeneration
Drug: Squalamine Lactate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Masked, Controlled Study of Squalamine Lactate (MSI-1256F) for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Genaera Corporation:

Primary Outcome Measures:
  • Loss in best corrected visual acuity (BCVA) of greater than or equal to 15 letters (ETDRS) at 52 weeks in the study eye compared to baseline.

Secondary Outcome Measures:
  • Change in retinal thickness in the study eye at 52 and 104 weeks compared to baseline, as measured by OCT, in a subset of subjects
  • Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography
  • Gain or loss in BCVA of greater than or equal to 15 letters (ETDRS) at 52 and 104 weeks in the fellow eye compared to baseline in the subgroup of subjects whose fellow eye is affected with wet AMD
  • Loss in binocular visual acuity of greater than or equal to 15 letters at 52 and 104 weeks compared to baseline, using a modified ETDRS protocol.

Study Start Date: June 2005
  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 in the affected eye in the past 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139282

  Show 29 Study Locations
Sponsors and Collaborators
Genaera Corporation
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00139282     History of Changes
Other Study ID Numbers: MSI-1256F-301
Study First Received: August 29, 2005
Last Updated: November 27, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Genaera Corporation:
wet AMD
macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Squalamine
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014