Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00083967

Purpose

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.

Condition	Intervention	Phase
Retinal Detachment	Drug: denufosol tetrasodium (INS37217) Intravitreal Injection	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Denufosol INS37217

U.S. FDA Resources

Further study details as provided by Merck:

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

Estimated Enrollment:	160
Study Start Date:	May 2004
Estimated Study Completion Date:	April 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083967

Show 33 Study Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Amy Schaberg, BSN

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00083967 History of Changes
Other Study ID Numbers:	06-102
Study First Received:	June 3, 2004
Last Updated:	September 13, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

rhegmatogenous retinal detachment
detached retina
retinal tear
retinal break

Additional relevant MeSH terms:

Retinal Detachment
Dissociative Disorders
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012