CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
OT-551 antioxidant eye dropdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00306488
NCT00306488Phase 2Completed
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A Phase II Study of OT-551 Antioxidant Eye Drop in Participants With Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration

National Institutes of Health Clinical Center (CC)·interventional·Posted Mar 23, 2006·Updated Jul 14, 2020

In Brief

A Phase 2 clinical trial evaluating OT-551 antioxidant eye drop for Geographic Atrophy and 2 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed Summary

Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic treatment of the dry form of age-related macular degeneration. This pilot study of up to 10 eye drop tolerant participants with bilateral geographic atrophy is designed to characterize the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression of geographic atrophy area over a two-year period. Participants will have one eye randomized to receive the eye drop and the fellow eye will be observed only.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeographic Atrophy, Age-Related Macular Degeneration, AMD
CountriesUnited States
CollaboratorsNational Eye Institute (NEI), Othera Pharmaceuticals

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 23, 2006
Enrollment StartMar 1, 2006
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 20.3 years ago

Interventions

OT-551 antioxidant eye dropdrug

0.45% concentration of OT-551 eye drops were given three times a day on participants with geographic atrophy area for up to three years. Participants had one eye randomized to receive the eye drop and the fellow eye was observed.