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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03845582
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Alkeus Pharmaceuticals, Inc.

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.


Condition or disease Intervention/treatment Phase
Geographic Atrophy Age Related Macular Degeneration AMD Atrophy, Geographic Drug: ALK-001 oral capsule Drug: Placebo oral capsule Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALK-001
Capsule
Drug: ALK-001 oral capsule
Daily administration for 24 months
Other Names:
  • C20-D3-Retinyl Acetate
  • C20 Deuterated vitamin A

Placebo Comparator: Placebo
Capsule
Drug: Placebo oral capsule
Daily administration for 24 months




Primary Outcome Measures :
  1. Growth rate of GA lesions, as assessed by Fundus Autofluorescence (FAF) [ Time Frame: Baseline to 24 months ]

Secondary Outcome Measures :
  1. Safety and tolerability, as assessed by evaluation of adverse events [ Time Frame: Baseline to 24 months ]
  2. Pharmacokinetics, as assessed by plasma concentrations of ALK-001 and metabolites [ Time Frame: Baseline to 24 months ]
  3. Incidence of choroidal neovascularization (CNV) [ Time Frame: Baseline to 24 months ]
  4. Changes in Visual Acuity [ Time Frame: Baseline to 24 months ]
  5. Changes in Reading Speed [ Time Frame: Baseline to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845582


Contacts
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Contact: Leonide Saad, PhD 800-287-2755 sagainfo@sagastudy.com

Locations
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United States, Massachusetts
Coordinating Center Recruiting
Somerville, Massachusetts, United States, 02144
Sponsors and Collaborators
Alkeus Pharmaceuticals, Inc.
Investigators
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Study Director: Leonide Saad, PhD Alkeus Pharmaceuticals, Inc.

Publications:
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Responsible Party: Alkeus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03845582    
Other Study ID Numbers: ALK001-P3001
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Vitamin A
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs