OT-551 Antioxidant Eye Drops to Treat Geographic Atrophy in Age-Related Macular Degeneration

NCT00306488 | Completed Phase 2 Results DMC

• 2 other identifiers: 06011606-EI-0116
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Geographic Atrophy; Age-Related Macular Degeneration; AMD

Keywords

Retinal Pigment Epithelium; Dynamic Light Scattering (DLS); Visual Acuity Decrease; Intra-ocular Pressure; Autofluorescence of Retina; Age-Related Macular Degeneration; AMD

Outcome Measures

Primary Outcomes (1)

• The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants.

  Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.

  2 years

Secondary Outcomes (5)

• The Change in Geographic Atrophy (GA), as Measured on Fundus Autofluorescence Imaging Using a Confocal Scanning Ophthalmoscope (HRA FAF) From Baseline to Year 2.

  2 years

• The Change in GA, as Measured on Stereoscopic Color Fundus Photography (CFP) From Baseline to Year 2.

  2 years

• The Change in Contrast Sensitivity as Measured by the Pelli-Robson Chart From Baseline to Year 2.

  2 years

• Number of Participants With an Increase in the Number of Scotomatous Points Between Study and Fellow Eyes From Baseline to Year 2.

  2 years

• The Change in Total Drusen Area From Baseline to Year 2.

  Baseline, 2 years

Study Arms (1)

OT-551 antioxidant eye drop

EXPERIMENTAL

The fellow eye was treated with OT-551 antioxidant eye drops over the course of the study.

Drug: OT-551 antioxidant eye drop

Interventions

OT-551 antioxidant eye drop DRUG

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.

OT-551 antioxidant eye drop

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must understand and sign the protocol's informed consent document (if the participant's vision is impaired to the point where it is not possible to read the informed consent document, the informed consent document will be read in its entirety to the participant).
• Participant must be able to administer the eye drops or have a caretaker administer the eye drops.
• Participant must have geographic atrophy (GA) present in both eyes compatible with age-related macular degeneration (AMD). GA is defined as one or more well-defined, usually more or less circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round-ish patch of RPE partial depigmentation may still be classified as early GA. The GA in each eye must be able to be photographed in their entirety and not contiguous with any areas of peripapillary atrophy, which can complicate area measurements.
• Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs.
• Female participants of child bearing potential (those who are not post-menopausal or surgically sterile) may participate if they are not lactating and if they agree to adequate birth control methods.

You may not qualify if:

• Participant is \> 60 years of age (to minimize fundus changes from causes other than AMD).
• Participant is in another investigational study and actively receiving study therapy.
• Participant is unable to comply with study procedures or follow-up visits.
• Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (e.g., diabetic retinopathy, uveitis, etc.).
• Participant has a chronic requirement (e.g., ≥ four weeks at a time) for ocular medications for diseases, that in the judgment of the examining physician, are vision threatening or may affect the primary outcome (artificial tears are permitted).
• Participant has evidence of pseudovitelliform macular degeneration that may confound the outcome of the study in either eye.
• Participant with evidence of vitreo-retinal traction maculopathy that may confound the outcome of the study in either eye.
• Participant has a history of laser, photodynamic therapy (PDT), intravitreal injection of any agent (e.g., anti-VEGF, triamcinolone, etc.), or any previous treatment for AMD other than AREDS or equivalent supplement formulation in the study eye.
• Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty.
• Participant has undergone lens removal in the last three months.
• Participant is on chemotherapy.
• Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
• Participant with a history of malignancy that would compromise the 2-year study survival.
• Participant with a history of ocular Herpes simplex virus.
• Participant with a history of or demonstration of allergy to benzakonium chloride, a preservative agent used in the eye drop.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Eye Institute (NEI): collaborator
• Othera Pharmaceuticals: collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (6)

• Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001 Oct;119(10):1417-36. doi: 10.1001/archopht.119.10.1417.

  PMID: 11594942 BACKGROUND

• Klein R, Klein BE, Jensen SC, Meuer SM. The five-year incidence and progression of age-related maculopathy: the Beaver Dam Eye Study. Ophthalmology. 1997 Jan;104(1):7-21. doi: 10.1016/s0161-6420(97)30368-6.

  PMID: 9022098 BACKGROUND

• Klein R, Klein BE, Linton KL. Prevalence of age-related maculopathy. The Beaver Dam Eye Study. Ophthalmology. 1992 Jun;99(6):933-43. doi: 10.1016/s0161-6420(92)31871-8.

  PMID: 1630784 BACKGROUND

• Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.

  PMID: 37702300 DERIVED

• Meleth AD, Mettu P, Agron E, Chew EY, Sadda SR, Ferris FL, Wong WT. Changes in retinal sensitivity in geographic atrophy progression as measured by microperimetry. Invest Ophthalmol Vis Sci. 2011 Feb 28;52(2):1119-26. doi: 10.1167/iovs.10-6075. Print 2011 Feb.

  PMID: 20926818 DERIVED

• Wong WT, Kam W, Cunningham D, Harrington M, Hammel K, Meyerle CB, Cukras C, Chew EY, Sadda SR, Ferris FL. Treatment of geographic atrophy by the topical administration of OT-551: results of a phase II clinical trial. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6131-9. doi: 10.1167/iovs.10-5637. Epub 2010 Jun 23.

  PMID: 20574018 DERIVED

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Wai Wong, MD, PhD
• Organization: National Eye Institute

wongw@mail.nih.gov

301-496-7566

Study Officials

• Wai Wong, MD, PhD

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2006
• First Posted: March 23, 2006
• Study Start: March 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 14, 2020
• Results First Posted: July 29, 2011

Record last verified: 2011-08

Locations

US (1)