Evidence map›Paper›PMID 32418846›Full record

Trial reportOphthalmology. Retina2020

Orally Administered Alpha Lipoic Acid as a Treatment for Geographic Atrophy: A Randomized Clinical Trial.

Benjamin J Kim, Allan Hunter, Alexander J Brucker, Paul Hahn, Karen Gehrs, Apurva Patel, Albert O Edwards, Yafeng Li, Rahul N Khurana, Itzhak Nissim and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology. Retina, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05808946 (The Effect of Alpha-Lipoic Acid on the Clinical Outcome of Patients With Sepsis), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05808946 phase2 / phase3unknown statusnot on this mapstarted 2023, after this paper: background citation

The Effect of Alpha-Lipoic Acid on the Clinical Outcome of Patients With Sepsis

TypeinterventionalSponsorAin Shams UniversityRan2023 to 2024Enrolled60ConditionsSepsisArmsAlpha-Lipoic Acid, Sepsis Supportive Care
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
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  5. Review
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  8. Evolution of macular atrophy in eyes with neovascular age-related macular degeneration compared to fellow non-neovascular eyes.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2023
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Benjamin J KimScheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: Benjamin.Kim@uphs.upenn.edu.
Allan HunterOregon Eye Consultants, Eugene, Oregon.
Alexander J BruckerScheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Paul HahnNew Jersey Retina, Teaneck, New Jersey.
Karen GehrsDepartment of Ophthalmology, University of Iowa, Iowa City, Iowa.
Apurva PatelRetina Northwest, Portland, Oregon.
Albert O EdwardsOregon Retina, Eugene, Oregon.
Yafeng LiScheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Rahul N KhuranaNorthern California Retina Vitreous Associates, Mountain View, California.
Itzhak NissimDivision of Genetics and Metabolic Disease, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Pediatrics, Biochemistry and Biophysics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Ebenezer DanielScheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Juan GrunwaldScheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Gui-Shuang YingScheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Maxwell PistilliScheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Maureen G MaguireScheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Joshua L DunaiefScheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Penn Presbyterian Medical Center · USChildren's Hospital of Philadelphia · USMinnesota Eye Consultants · USRetina Associates · USRetina Vitreous Associates of Florida · USUniversity of Iowa · US

Funding

Scientific TransparencyP30EY001583 · NEI · UNIVERSITY OF PENNSYLVANIA · PI CLAIRE H MITCHELL · 1985 to 2026
$19.5M
NEI NIH HHS P30 EY001583
6 · The paper itself

Abstract

purposeAlpha lipoic acid (ALA) is a nutraceutical and potent antioxidant that has shown efficacy in the retina light damage mouse model and in humans for multiple sclerosis. Our objective was to evaluate the efficacy and safety of oral ALA for the treatment of geographic atrophy (GA).

designRandomized, controlled, double-masked, multicenter phase 2 clinical trial of ALA versus placebo.

participantsParticipants with unilateral or bilateral GA from age-related macular degeneration.

methodsParticipants were randomized to 1200 mg daily of ALA or placebo. Fundus autofluorescence, fundus color photography, and spectral-domain OCT were conducted and best-corrected visual acuity (BCVA) was obtained at baseline and every 6 months through month 18.

main outcome measuresAnnual rate of change over 18 months in square root-transformed area of GA in study eyes as measured on fundus autofluorescence. Secondary outcomes included the number of adverse events (AEs), change in BCVA, and annual rate of change in area of GA measured on color photographs.

resultsFifty-three participants (mean age, 80 years) were randomized (April 2016-August 2017). Twenty-seven participants (37 eyes) were in the placebo group, and 26 participants (36 eyes) were in the ALA group. Unadjusted mean (standard error) annual change in GA area was 0.28 (0.02) mm and 0.31 (0.02) mm for the placebo and ALA groups, respectively (difference, 0.04 mm; 95% confidence interval [CI], -0.03 to 0.11 mm; P = 0.30). Adjusting for baseline GA area, number of GA lesions, and presence of subfoveal GA, the mean annual change in GA area was 0.27 (0.04) mm and 0.32 (0.05) mm for the placebo and ALA groups, respectively (difference, 0.05 mm; 95% CI, -0.02 to 0.12 mm; P = 0.14). At 18 months, the percent of eyes losing 15 letters or more of BCVA was 22% (8 of 36) and 14% (5 of 36) in the placebo and ALA groups, respectively (P = 0.54). No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.

conclusionsResults do not support ALA having beneficial effects on GA or BCVA. This trial design may be useful for other GA repurposing drug trials.

Indexed as

Visual AcuityAdministration, OralAgedAged, 80 and overAntioxidantsDose-Response Relationship, DrugDouble-Blind MethodFemaleFluorescein AngiographyFundus OculiGeographic AtrophyHumansMaleProspective StudiesThioctic AcidTreatment OutcomeAntioxidantsThioctic Acid

Identifiers

PMID32418846
PMCPMC7483261
OpenAlexW3015186627

What OpenQuestion holds

Textmetadata
LicenceTDM
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.