Retinal Detachment
Conditions
Keywords
rhegmatogenous retinal detachment, detached retina, retinal tear, retinal break
Brief 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.
Detailed description
The purpose of this trial is to determine if administration of denufosol is well-tolerated and more efficacious than placebo in stimulating subretinal fluid reabsorption and retinal reattachment without surgical intervention in subjects presenting with rhegmatogenous retinal detachment.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo | — |
| Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Identify one or more dose levels of denufosol as safe and potentially effective to warrant study in Phase 3 | — |
| Evaluate utility of 3D B-scan ultrasound technology as endpoint for objectively describing volume of retinal detachment | — |
Countries
United States
Outcome results
None listed