Full Text View
Tabular View
No Study Results Posted
Related Studies
Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
This study has been terminated.
Study NCT00083967   Information provided by Inspire Pharmaceuticals
First Received: June 3, 2004   Last Updated: September 13, 2005   History of Changes

June 3, 2004
September 13, 2005
May 2004
 
  • 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
Same as current
Complete list of historical versions of study NCT00083967 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
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

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.

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.

Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Retinal Detachment
Drug: denufosol tetrasodium (INS37217) Intravitreal Injection
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
160
April 2006
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00083967
 
06-102
Inspire Pharmaceuticals
 
Study Director: Amy Schaberg, BSN Unaffiliated
Inspire Pharmaceuticals
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP