Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
This study has been terminated.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: June 3, 2004
Last updated: October 31, 2013
Last verified: October 2013
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.
Drug: denufosol tetrasodium (INS37217) Intravitreal Injection
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Randomized, Double-Masked, Placebo Controlled, Parallel Group, Multi-Center, Dose-Ranging Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Rhegmatogenous Retinal Detachment
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2006 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083967
Merck Sharp & Dohme Corp.
||Amy Schaberg, BSN
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 3, 2004
||October 31, 2013
||United States: Food and Drug Administration
Keywords provided by Merck Sharp & Dohme Corp.:
rhegmatogenous retinal detachment
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014