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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 baseline to 24 months
Awards & highlights

SAGA Trial Summary

This trial will last for approximately 3 years.

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.Check my eligibility
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.See study design
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.

SAGA 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.

SAGA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Growth rate of GA lesions, as assessed by Fundus Autofluorescence (FAF)
Secondary outcome measures
Changes in Reading Speed
Changes in Visual Acuity
Incidence of choroidal neovascularization (CNV)
+2 more

SAGA Trial Design

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other similar medications to ALK-001 oral capsule?

"As of right now, there are a total of 9 ongoing clinical studies surrounding ALK-001 oral capsule. Out of those 9, 2 are currently in Phase 3. The oral capsule is being tested in 14 different locations, with the majority of those trials taking place in Somerville, Massachusetts."

Answered by AI

ALK-001 oral capsule is typically used to treat what type of condition?

"ALK-001 oral capsules can be used to correct vitamin deficiencies that lead to health problems, such as vitamin d or A deficiency."

Answered by AI

Are new patients being enrolled in this clinical trial currently?

"Presently, this clinical trial is not recruiting patients. However, it was first posted on May 7th, 2019 and was most recently updated on February 15th, 2022. There are a total of 331 clinical trials actively enrolling patients with geographic atrophy and 9 studies for ALK-001 oral capsule that are actively looking for patients."

Answered by AI

How many people are being given the chance to participate in this experiment?

"This research is not looking for patients at the moment. The trial was first posted on 07/05/2019 and was last updated on 15/02/2022. If you are interested in other studies, there are currently 331 trials enrolling patients with geographic atrophy and 9 trials for ALK-001 oral capsule admitting patients."

Answered by AI

Have there been other similar trials to this one in the past?

"Alkeus Pharmaceuticals, Inc. first conducted a clinical trial for ALK-001 oral capsule in 2015. Since then, 9 other trials have been completed in 11 cities across 2 countries. A total of 203 trials have been completed for this medication since 2015."

Answered by AI

Has ALK-001 been cleared for public consumption by the FDA?

"ALK-001 oral capsule has received a score of 3 for safety. This is because it is a Phase 3 trial, meaning that there is both some efficacy data and multiple rounds of safety data."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
Coordinating Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~51 spots leftby Mar 2025