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NCT02613572 · ClinicalTrials.gov registry record · Phase 1
Alpha Lipoic Acid in Geographic Atrophy
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT02613572: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT02613572 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 68 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02613572, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
Because of its iron-chelating and antioxidant properties, alpha lipoic acid may be a treatment for geographic atrophy (GA) secondary to age-related macular degeneration. There is ample published data about the safety and pharmacokinetics of alpha lipoic acid in adults. However, there is not much data on the safety and tolerability of higher doses of alpha lipoic acid in the elderly population. The purpose of Phase I of this protocol is to determine if there are safety/tolerability concerns seen when higher doses of alpha lipoic acid are taken by subjects 65 years of age or older. The objective of Phase 2 of this protocol is to determine the effects of ALA on the progression of GA in subjects with AMD. The central hypothesis, based on the existing literature, is that oral ALA reduces the rate of enlargement of GA in AMD subjects. The rationale is that the antioxidant and iron chelating effects of ALA will slow down one of the major pathways responsible for GA progression.
Interventions
- DRUG Placebo
- DRUG alpha lipoic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2015-11 |
| Est. Completion | 2019-03-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02613572
The ClinicalTrials.gov registry entry for NCT02613572 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02613572 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02613572 about?
NCT02613572 is a clinical study titled "Alpha Lipoic Acid in Geographic Atrophy". Because of its iron-chelating and antioxidant properties, alpha lipoic acid may be a treatment for geographic atrophy (GA) secondary to age-related macular degeneration. There is ample published data about the safety and pharmacokinetics of alpha lipoic acid in adults. However, there is not much dat...
What is the current status of trial NCT02613572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2015-11. Estimated completion is 2019-03-01.
What interventions are being tested in trial NCT02613572?
The interventions under investigation include: Placebo (DRUG), alpha lipoic acid (DRUG).
Who is sponsoring clinical trial NCT02613572?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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