Ignite Creation Date:
2024-05-06 @ 12:47 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03845582
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2019-02-15
Brief Title:
Phase 3 Study of ALK-001 in Geographic Atrophy
Sponsor:
Alkeus Pharmaceuticals Inc
Organization:
Alkeus Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 23 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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAGA
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
Up to 200 participants will receive ALK-001 while up to 100 participants will receive a placebo
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 Bruchs 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
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 Bruchs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None