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| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 29, 2005 |
| Last Updated Date | November 27, 2007 |
| Start Date ICMJE | June 2005 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
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. |
| Original Primary Outcome Measures ICMJE |
Loss in BCVA of greater than or equal to 15 letters (ETDRS) at 104 weeks in the study eye compared to baseline |
| Change History | Complete list of historical versions of study NCT00139282 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
|
| Original Secondary Outcome Measures ICMJE |
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. |
| Descriptive Information | |
| Brief Title ICMJE | A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration |
| Official Title ICMJE | 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 |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE | "Wet" Age-Related Macular Degeneration |
| Intervention ICMJE | Drug: Squalamine Lactate |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Terminated |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 50 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00139282 |
| Responsible Party | |
| Study ID Numbers ICMJE | MSI-1256F-301 |
| Study Sponsor ICMJE | Genaera Corporation |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Genaera Corporation |
| Verification Date | November 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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