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Phase 3 Study of ALK-001 in Geographic Atrophy (SAGA)

A

Alkeus Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Age Related Macular Degeneration
Atrophy, Geographic
Geographic Atrophy
AMD

Treatments

Drug: Placebo oral capsule
Drug: ALK-001 oral capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT03845582
ALK001-P3001

Details and patient eligibility

About

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.

Full description

There is no treatment available for Geographic Atrophy secondary to AMD. AMD is characterized by an age-related degeneration of the retina.

The root cause for this degeneration or why some people develop AMD while others do not, is unknown. Over 20 years ago, it was hypothesized that the dimerization of vitamin A may be a significant contributor to the etiology of AMD. The eye indeed uses vitamin A as a cofactor to sense light, and a striking chemical signature of the aging and degenerating retina is the accumulation of vitamin A dimers in the retinal pigment epithelium (RPE) and the underlying Bruch's membrane. In rodent models, high levels of vitamin A dimers correlate with poor retinal health, and a variety of mechanisms have been proposed by which vitamin A dimers may induce retinal toxicity. It has been argued that these mechanisms participate in the development and progression of AMD.

ALK-001, the study drug, is a modified form of vitamin A. When taken once a day as a capsule, it replaces natural vitamin A in the body with one that forms vitamin A dimers more slowly. This study will measure the extent to which treatment with ALK-001 slows the progression of Geographic Atrophy.

Enrollment

200 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups, including a placebo group

ALK-001
Experimental group
Description:
Capsule
Treatment:
Drug: ALK-001 oral capsule
Placebo
Placebo Comparator group
Description:
Capsule
Treatment:
Drug: Placebo oral capsule

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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