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

Othera Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Macular Hole; Epiretinal Membrane

Treatments: Drug: OT-551 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333060

OT-551-002

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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