Age Related Macular Degeneration Clinical Trial
— SAGAOfficial title:
A Phase 2/3 Multicenter, Randomized, Double-masked, Parallel-group, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, Tolerability, and Efficacy of ALK-001 in Geographic Atrophy Secondary to Age-related Macular Degeneration
Verified date | January 2024 |
Source | Alkeus Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a double-masked, multicenter, randomized, placebo-controlled clinical trial, evaluating the efficacy and safety of ALK-001 in participants with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). Up to 200 participants will receive ALK-001 while up to 100 participants will receive a placebo.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | April 1, 2024 |
Est. primary completion date | July 25, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Major Inclusion Criteria: - At least one eye with geographic atrophy secondary to dry age-related macular degeneration (AMD) Major Exclusion Criteria: - Medical condition, which may interfere with the progression of GA, prevent performance of study procedures, compliance with protocol, or continuous participation in the study |
Country | Name | City | State |
---|---|---|---|
United States | Coordinating Center | Somerville | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Alkeus Pharmaceuticals, Inc. |
United States,
Kaufman Y, Ma L, Washington I. Deuterium enrichment of vitamin A at the C20 position slows the formation of detrimental vitamin A dimers in wild-type rodents. J Biol Chem. 2011 Mar 11;286(10):7958-7965. doi: 10.1074/jbc.M110.178640. Epub 2010 Nov 12. — View Citation
Mihai DM, Jiang H, Blaner WS, Romanov A, Washington I. The retina rapidly incorporates ingested C20-D(3)-vitamin A in a swine model. Mol Vis. 2013 Jul 25;19:1677-83. Print 2013. — View Citation
Saad L, Washington I. Can Vitamin A be Improved to Prevent Blindness due to Age-Related Macular Degeneration, Stargardt Disease and Other Retinal Dystrophies? Adv Exp Med Biol. 2016;854:355-61. doi: 10.1007/978-3-319-17121-0_47. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Growth rate of GA lesions, as assessed by Fundus Autofluorescence (FAF) | Baseline to 24 months | ||
Secondary | Safety and tolerability, as assessed by evaluation of adverse events | Baseline to 24 months | ||
Secondary | Pharmacokinetics, as assessed by plasma concentrations of ALK-001 and metabolites | Baseline to 24 months | ||
Secondary | Incidence of choroidal neovascularization (CNV) | Baseline to 24 months | ||
Secondary | Changes in Visual Acuity | Baseline to 24 months | ||
Secondary | Changes in Reading Speed | Baseline to 24 months |
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