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
Data Collection
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Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.23 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 33 locations
Retina-Vitreous Associates Medical Group
Beverly Hills, United StatesRetina Vitreous Associates Medical Group
Los Angeles, United StatesRetina Consultants San Diego
Poway, United States