Evidence map›Paper›PMID 20574018›Full record

Trial reportInvestigative ophthalmology & visual science2010

Treatment of geographic atrophy by the topical administration of OT-551: results of a phase II clinical trial.

Wai T Wong, Waynekid Kam, Denise Cunningham, Molly Harrington, Keri Hammel, Catherine B Meyerle, Catherine Cukras, Emily Y Chew, Srinivas R Sadda, Frederick L Ferris

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Investigative ophthalmology & visual science, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00306488 (A Phase II Study of OT-551 Antioxidant Eye Drop in Participants With Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration), which is not on this map. Cited by 55 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 4 pooled it
11.1field-weighted citation impact, top 1% 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.

NCT00306488 phase2completednot on this map

A Phase II Study of OT-551 Antioxidant Eye Drop in Participants With Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration

TypeinterventionalSponsorNational Institutes of Health Clinical Center (CC)Ran2006 to 2010Enrolled11ConditionsGeographic Atrophy, Age-Related Macular Degeneration, AMDArmsOT-551 antioxidant eye drop
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 4 syntheses or guidelines pooled it, 122 citations in OpenAlex.

  1. Pooled it
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  12. Different Therapeutic Approaches for Dry and Wet AMD.International journal of molecular sciences · 2024
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  18. Effect of Esculetin onMolecules (Basel, Switzerland) · 2022
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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

10 authors at 3 institutions in 1 country.

Wai T WongDivision of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD 20892, USA. wongw@xnei.nih.gov
Waynekid Kam
Denise Cunningham
Molly Harrington
Keri Hammel
Catherine B Meyerle
Catherine Cukras
Emily Y Chew
Srinivas R Sadda
Frederick L Ferris
Research Applications (United States) · USEmmes (United States) · USNational Eye Institute · US

Funding

Medical Retina FellowshipZIEEY000487 · NEI · NATIONAL EYE INSTITUTE · PI KEENAN, TIARNAN · 2009 to 2025
$6.6M
Eval. of Subconjunctival Sirolimus in Treatment of Bilateral Geographic AtrophyZIAEY000495 · NEI · NATIONAL EYE INSTITUTE · PI CHEW, EMILY Y · 2010 to 2015
$812k
SNPs in Patients with and without Diabetic Macular Edema ZIAEY000497 · NEI · NATIONAL EYE INSTITUTE · PI FERRIS, FREDERICK · 2010 to 2013
$209k
Evaluation of Sirolimus in the Treatment of Diabetic Macular Edema ZIAEY000494 · NEI · NATIONAL EYE INSTITUTE · PI FERRIS, FREDERICK · 2010 to 2010
$9k
Intramural NIH HHS Z99 EY999999
6 · The paper itself

Abstract

purposeTo investigate the safety and preliminary efficacy of OT-551, a disubstituted hydroxylamine with antioxidant properties, for the treatment of geographic atrophy (GA), the advanced atrophic form of age-related macular degeneration (AMD).

methodsThe study was a single-center, open-label phase II trial, enrolling 10 participants with bilateral GA. Topical 0.45% OT-551 was administered in one randomly assigned eye three times daily for 2 years. Safety measures were assessed by complete ophthalmic examination, fundus photography, and review of symptoms. The primary efficacy outcome measure was the change in best corrected visual acuity at 24 months. Secondary efficacy measures included changes in area of GA, contrast sensitivity, microperimetry measurements, and total drusen area from baseline.

resultsStudy drug was well tolerated and was associated with few adverse events. The mean change in BCVA at 2 years was +0.2 ± 13.3 letters in the study eyes and -11.3 ± 7.6 letters in fellow eyes (P = 0.0259). However, no statistically significant differences were found between the study and fellow eyes for all other secondary outcome measures.

conclusionsOT-551 was well tolerated by study participants and was not associated with any serious adverse effects. Efficacy measurements in this small study indicate a possible effect in maintaining visual acuity. However, the absence of significant effects on other outcomes measures in this study suggests that OT-551, in the current concentration and mode of delivery, may have limited or no benefit as a treatment for GA (ClinicalTrials.gov number, NCT00306488).

Indexed as

Administration, TopicalAgedAged, 80 and overAnti-Inflammatory AgentsAntioxidantsContrast SensitivityFemaleGeographic AtrophyHumansMalePilot ProjectsPiperidinesTreatment OutcomeVisual AcuityVisual FieldsVisual Field TestsAnti-Inflammatory AgentsAntioxidantsOT-551Piperidines

Identifiers

PMID20574018
PMCPMC3055748
OpenAlexW1978412174

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.