Suspended

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

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What is being tested

Data Collection

Who is being recruted

Mental Disorders
+2

+ Dissociative Disorders
+ Eye Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004Actual 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.

Official TitleA Randomized, Double-Masked, Placebo Controlled, Parallel Group, Multi-Center, Dose-Ranging Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Rhegmatogenous Retinal Detachment 
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
23 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Mental Disorders
Dissociative Disorders
Eye Diseases
Retinal Detachment
Retinal Diseases
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
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
Suspended
Retina Center, P.C.Tucson, United StatesSee the location
Suspended
Retina-Vitreous Associates Medical GroupBeverly Hills, United States
Suspended
Retina Vitreous Associates Medical GroupLos Angeles, United States
Suspended
Retina Consultants San DiegoPoway, United States

Suspended33 Study Centers
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