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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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). 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.
Primary Outcome
The percent of adverse events that develop will be stratified by the alpha lipoic acid dose.
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 |
What the finished NCT02613572 record still lists
NCT02613572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02613572 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02613572's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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