Alpha Lipoic Acid in Geographic Atrophy

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT02613572

Run by

University of Pennsylvania

People needed

68

Starts

2015-11-01

Expected to finish

2019-03-01

Last updated by the study team

2020-08-06

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages 65-90
• Female participants must be menopausal. Male participants are required to use contraception.
• Able to give informed consent
• For the study duration (15 days), the subject must remain in the country, remain within 4 hours of travel time (by car or airplane), have access to medical care if needed, and provide contact information so the subject can be reached as needed.

You may not qualify if…

• Blood Pressure greater than 190/100 at the baseline visit
• Pulse greater than 100 at the baseline visit
• Acute and ongoing systemic infection
• History of dementia
• Participant has a condition that, in the opinion of the investigator, gives them an unstable medical status.
• Participant has geographic atrophy and the investigator believes the participant is a candidate for enrollment into the planned Phase 2 trial for geographic atrophy.
• Phase II
• Inclusion Criteria
• Age 55-90
• Diagnosis of geographic atrophy from age-related macular degeneration in the study eye. The largest geographic atrophy (GA) lesion must be a minimum of 0.5 optic disk area (DA) (1.25 mm2) and no more than 6 DA in size (15.0 mm2). GA is defined as one or more well-defined, usually more or less circular patches of loss of the retinal pigment epithelium (RPE), typically with exposure of underlying choroidal blood vessels. If the GA is multifocal and the largest lesion is < 0.5 DA, then there should be at least 3 lesions ≥ 250 microns in greatest linear diameter.
• Best-Corrected Visual Acuity (BCVA) between 20/20 and 20/400 in the study eye.
• Female participants must be menopausal. Male participants are required to use contraception and cannot donate sperm during study participation.
• Presence of hyperfluorescence at the edge of GA on autofluorescence imaging.
• Ability to give informed consent.
• If a subject has two eligible eyes, then both eyes can be enrolled into the study.
• Subject must have mailed back the medication bottle after the 10 day run-in phase, demonstrating that they have taken ≥ 80% of the capsules.
• Exclusion Criteria
• Evidence of ocular disease other than AMD in the study eye that may confound the study outcomes (e.g., History of myopic degeneration, choroidal neovascularization, central serous chorioretinopathy, severe diabetic retinopathy, uveitis, vitelliform dystrophy, or macular edema).
• Presence of geographic atrophy that is already touching clearly defined beta peripapillary atrophy or is already touching the optic disc. Beta peripapillary atrophy is defined as peripapillary atrophy in which either the sclera or choroidal vessels are clearly visible.
• Any history of intravitreal injection in the study eye for AMD or choroidal neovascularization.
• However, if a subject develops choroidal neovascularization in the study eye during the study, then the subject will receive the standard of care intravitreal injection treatments per the investigator. The subject will continue to stay in the study. Treatment of choroidal neovascularization (CNV) or other diseases in the non-study eye is at the investigator's discretion.
• History of intravitreal injection of any agent (e.g., triamcinolone) other than anti-VEGF (vascular endothelial growth factor) in the study eye within the last four months prior to study enrollment.
• History of laser treatment (including photodynamic therapy) to the macula for the study eye.
• History of intraocular surgery within 90 days. for the study eye.
• History of anterior segment laser (laser peripheral iridotomy, laser to trabecular meshwork, YAG capsulotomy) within 90 days for the study eye.

Where it is running

• University of Iowa Hospitals and Clinics, Department of Ophthalmology & Visual Sciences — Iowa City, Iowa, United States
• NJ Retina — Teaneck, New Jersey, United States
• Oregon Regina. LLP — Eugene, Oregon, United States
• Retina Northwest, P.C. — Portland, Oregon, United States
• Scheie Eye Institute of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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