Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01678963|
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : June 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age Related Macular Degeneration||Drug: Squalamine lactate Drug: Vehicle control||Phase 2|
Age-related macular degeneration (AMD) is a degenerative retinal eye disease 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 and affects 25-30 million people globally. This number is expected to triple over the next 25 years. Central vision loss from AMD is caused by the degeneration of light-sensing cells in the macula called photoreceptors. The macula, the central portion of the retina, is responsible for perceiving fine visual detail. As photoreceptors begin to degenerate, so does the individual's central vision. The extent of vision loss varies widely and is related to the type of AMD, its severity and other individual characteristics.
AMD presents itself in two different forms — a "dry" form and the more severe "wet" form. Dry AMD, the more common and milder form of AMD, accounts for 85% to 90% of all cases. It results in varying forms of sight loss and may or may not eventually develop into the wet form. Although the wet form of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight loss is much greater. Wet AMD is responsible for 90% of severe vision loss associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed annually worldwide. In North America alone, approximately 200,000 new cases of wet AMD are diagnosed each year.
Squalamine lactate has been found to be an inhibitor of new blood vessel formation (angiogenesis) induced by VEGF, PDGF or bFGF. Since angiogenesis is implicated in the growth and maintenance of choroidal neovascularization, squalamine lactate is potentially an attractive development candidate in the treatment of age-related macular degeneration (AMD), in which blood vessel proliferation has a role.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Formulation 0.2% BID in Subjects With Neovascular AMD.|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Squalamine eye drop 0.2%
Drug: Squalamine lactate
Ophthalmic solution 0.2%
Placebo Comparator: Vehicle Control
Eye drop vehicle control
Drug: Vehicle control
Ophthalmic solution vehicle control
- Need for continued concomitant therapy [ Time Frame: 9 months ]Lucentis (ranibizumab) is the current standard of care for the treatment of wet AMD. All patients will receive an initial injection of Lucentis prior to randomization and then be evaluated monthly for their need for further Lucentis injections using protocol defined retreatment criteria.
- Best Corrected Visual Acuity (BCVA) [ Time Frame: 9 months ]Evaluation of the effect of treatment on visual function (BCVA) as measured using the EDTRS chart measured at an initial distance of 4 meters.
- Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 9 months ]The frequency, severity, seriousness of all adverse events including their relationship to study drug and effect on discontinuation from the study will be monitored, recorded and analysed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678963