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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00083967
First received: June 3, 2004
Last updated: October 31, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 23
Study Start Date: June 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
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
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

  Show 33 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Amy Schaberg, BSN
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00083967     History of Changes
Other Study ID Numbers: 06-102
Study First Received: June 3, 2004
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
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 September 14, 2014