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Retinoid

ALK-001 oral capsule for Age-Related Macular Degeneration (SAGA Trial)

Phase 3
Waitlist Available
Research Sponsored by Alkeus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- At least one eye with geographic atrophy secondary to dry age-related macular degeneration (AMD)
At least one eye with geographic atrophy secondary to dry age-related macular degeneration (AMD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a special type of vitamin A in people with vision loss due to Geographic Atrophy from age-related macular degeneration. The goal is to see if this vitamin can slow down the damage to the retina by reducing harmful clumps of vitamin A. There are no current treatments for this condition, making this study important for those affected.

Who is the study for?
This trial is for people with a condition called Geographic Atrophy (GA) that's due to dry age-related macular degeneration. Participants need to have at least one eye affected by GA. They shouldn't have any health issues that could mess with the study or stop them from following the trial procedures and staying in the study.
What is being tested?
The trial is testing ALK-001, an oral capsule, against a placebo (a pill without active medication). It's a phase 3 study where participants are randomly chosen to receive either ALK-001 or placebo, and neither they nor the researchers know who gets what—a method known as double-masking.
What are the potential side effects?
Specific side effects of ALK-001 aren't provided here, but common side effects for oral medications can include stomach upset, headache, dizziness, or allergic reactions. The safety profile will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have dry AMD causing vision loss in at least one eye.
Select...
I have vision loss in at least one eye due to dry AMD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALK-001Experimental Treatment1 Intervention
Capsule
Group II: PlaceboPlacebo Group1 Intervention
Capsule

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Age-Related Macular Degeneration (AMD) often focus on reducing oxidative stress and preventing the accumulation of toxic byproducts in the retina. ALK-001, a modified form of vitamin A, aims to slow the progression of geographic atrophy by reducing the formation of toxic vitamin A dimers, which can damage retinal cells. This is crucial for AMD patients as it helps preserve vision by protecting retinal cells from degeneration. Other treatments, such as antioxidants, work by neutralizing free radicals, thereby preventing oxidative damage to the retina. These mechanisms are vital for maintaining retinal health and slowing the progression of AMD.
Treatment of geographic atrophy by the topical administration of OT-551: results of a phase II clinical trial.

Find a Location

Who is running the clinical trial?

Alkeus Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
320 Total Patients Enrolled
Leonide Saad, PhDStudy DirectorAlkeus Pharmaceuticals, Inc.
3 Previous Clinical Trials
320 Total Patients Enrolled

Media Library

ALK-001 (Retinoid) Clinical Trial Eligibility Overview. Trial Name: NCT03845582 — Phase 3
Age-Related Macular Degeneration Research Study Groups: ALK-001, Placebo
Age-Related Macular Degeneration Clinical Trial 2023: ALK-001 Highlights & Side Effects. Trial Name: NCT03845582 — Phase 3
ALK-001 (Retinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03845582 — Phase 3
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