Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment

• Status: Terminated
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test if denufosol will remove the fluid build-up in the eye so that the retina can be re-attached without invasive surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• have rhegmatogenous retinal detachment in only one eye

• be able to receive intravitreal injection of study drug and be able to wait 24(+/- 6) hours to have detachment surgically treated or retinal breaks repaired per judgement of investigator

• no more than 3 separate identifiable retinal breaks that are clustered together and confined within an area no more than 2 clock hours in extent

• retinal detachment must be large enough such that it cannot be immediately repaired with laser photocoagulation or cryotherapy

• have pinhole acuity (using ETDRS) of macula-on, 20/50 or better in both eyes OR macula-off, 20/50 or better in non-study eye and have history, prior to detachment, of reading capability in study eye

Exclusion Criteria:

• have a non-rhegmatogenous retinal detachment

• have large retinal break(s) whose total break area is greater than 1 clock hour in extent

• have evidence of atrophic retinal pigment epithelium, choroid, choroidal detachment or intraocular inflammation

• be monocular

• have a prior retinal detachment repair or a congenital condition that places a greater risk for rhegmatogenous retinal detachment

• have proliferative vitreoretinopathy greater than grade B

• have pre-existing subretinal or vitreous hemorrhage, corneal opacity, or other conditions which limit the view of peripheral retina

• have any co-existing macular pathology or other retinal conditions that can limit visual acuity

• currently have uncontrollable elevated intraocular pressure, advanced glaucoma, or any history or current evidence of endophthalmitis in the affected eye

• have symptoms consistent with a rhegmatogenous retinal detachment such as visual disturbance greater than 14 days prior to screening if macula-on OR history of loss of reading vision in affected eye for greater than 6 days prior to screening if macula-off

• have a retinal detachment with evidence of demarcation lines or evidence of subretinal fibrosis visible upon fundus examination

• be currently taking medications that could obscure or confound study results including acetazolamide (Diamox) and dorzolamide

• have had a periocular, retrobulbar or intravitreal injection in the affected eye, including corticosteroids in the 3 months prior to screening or require one