Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal

Stopped early · Phase 2

Conditions studied: Epiretinal Membrane, Macular Hole

In brief

The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.

Key facts

Study ID

NCT00333060

Run by

Othera Pharmaceuticals

People needed

164

Starts

2005-11-01

Expected to finish

2008-01-01

Last updated by the study team

2008-04-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Imminent vitrectomy to repair macular holes or puckers
• Ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery
• Best corrected ETDRS visual acuity equivalent to Snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye

You may not qualify if…

• Artificial lens or no lens in the surgical eye
• Cataract (greater than slight opacity or thickness) in the surgical eye
• Any other retinal abnormality which may be vision-threatening
• Serious heart, kidney, or liver disease
• Recent ophthalmic surgery (within 6 months) or ocular infection (within 30 days)
• Poorly controlled diabetes or unstable glaucoma

Where it is running

• Study site — Peoria, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Sacramento, California, United States
• Study site — Denver, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Joliet, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Cherry Hill, New Jersey, United States
• Study site — Forrest Hills, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Bala-Cynwyd, Pennsylvania, United States
• Study site — West Chester, Pennsylvania, United States
• Study site — Abilene, Texas, United States

Full record on ClinicalTrials.gov

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