Phase 2/3 Study of ALK-001 in Geographic Atrophy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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There is no oral 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.

Conditions

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Geographic Atrophy Age Related Macular Degeneration AMD Atrophy, Geographic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALK-001

Capsule

Group Type EXPERIMENTAL

ALK-001 oral capsule

Intervention Type DRUG

Daily administration for 24 months

Placebo

Capsule

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Daily administration for 24 months

Interventions

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ALK-001 oral capsule

Daily administration for 24 months

Intervention Type DRUG

Placebo oral capsule

Daily administration for 24 months

Intervention Type DRUG

Other Intervention Names

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C20-D3-Retinyl Acetate C20 Deuterated vitamin A

Eligibility Criteria

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Inclusion Criteria

\- At least one eye with geographic atrophy secondary to dry age-related macular degeneration (AMD)

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No