Phase 2/3 Study of ALK-001 in Geographic Atrophy
SAGA
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
1 other identifier
interventional
200
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2019
Longer than P75 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedResults Posted
Study results publicly available
October 16, 2025
CompletedNovember 3, 2025
November 1, 2024
4.2 years
February 15, 2019
September 30, 2025
October 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Growth Rate of GA Lesions, as Assessed by Fundus Autofluorescence (FAF)
Baseline to 24 months
Secondary Outcomes (2)
Number of Participants With Adverse Events
Baseline to 24 months
Changes in Visual Acuity
Baseline to 24 months
Study Arms (2)
ALK-001
EXPERIMENTALCapsule
Placebo
PLACEBO COMPARATORCapsule
Interventions
Daily administration for 24 months
Eligibility Criteria
You may qualify if:
- \- At least one eye with geographic atrophy secondary to dry age-related macular degeneration (AMD)
You may not qualify if:
- \- Medical condition, which may interfere with the progression of GA, prevent performance of study procedures, compliance with protocol, or continuous participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Alkeus Site
Phoenix, Arizona, 85053, United States
Alkeus Site
Beverly Hills, California, 90211, United States
Alkeus Site
Lakewood, Colorado, 80228, United States
Alkeus Site
Clearwater, Florida, 33761, United States
Alkeus Site
Fort Myers, Florida, 33912, United States
Alkeus Site
Gainesville, Florida, 32601, United States
Alkeus Site
Tampa, Florida, 33609, United States
Alkeus Site
Winter Haven, Florida, 33880, United States
Alkeus Site
Bloomington, Illinois, 61704, United States
Alkeus Site
Lexington, Kentucky, 40509, United States
Alkeus Site
Chevy Chase, Maryland, 20815, United States
Alkeus Site
Worcester, Massachusetts, 01605, United States
Alkeus Site
Grand Rapids, Michigan, 49546, United States
Alkeus Site
Edina, Minnesota, 55435, United States
Alkeus Site
Northfield, New Jersey, 08225, United States
Alkeus Site
Great Neck, New York, 11021, United States
Alkeus Site
Hauppauge, New York, 11788, United States
Alkeus Site
Cleveland, Ohio, 44122, United States
Alkeus Site
Ashland, Oregon, 97520, United States
Alkeus Site
Houston, Texas, 77025, United States
Alkeus Site-1
San Antonio, Texas, 78240, United States
Alkeus Site-2
San Antonio, Texas, 78240, United States
Alkeus Site
Fairfax, Virginia, 22031, United States
Alkeus Site
Silverdale, Washington, 98383, United States
Related Publications (4)
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.
PMID: 21075840BACKGROUNDMihai 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.
PMID: 23914132BACKGROUNDSaad 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.
PMID: 26427432BACKGROUNDEvans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
PMID: 37702300DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Meena Venugopal
- Organization
- Alkeus Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 19, 2019
Study Start
May 7, 2019
Primary Completion
July 25, 2023
Study Completion
June 30, 2024
Last Updated
November 3, 2025
Results First Posted
October 16, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share