A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration
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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 |
- 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.
- 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 |
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
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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 May 16, 2013