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

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00083967
First received: June 3, 2004
Last updated: September 13, 2005
Last verified: September 2005
History of Changes
  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 2

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

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 June 17, 2013