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Retinal DetachmentPhase 2NCT00083967

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

A Phase 2 study testing denufosol tetrasodium (INS37217) Intravitreal Injection in people with Retinal Detachment, run by Merck Sharp & Dohme LLC at 33 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Detachment
What is being tested?
denufosol tetrasodium (INS37217) Intravitreal Injection
Type of treatment
Injection or infusion
How many people
23 participants
Where
33 sitesUnited States
Study dates
Jun 2004to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Austin Retina

    Austin, Texas, 78705

  • Maine Vitreoretinal Consultants

    Bangor, Maine, 04401

  • Retina Associates of Cleveland

    Beachwood, Ohio, 44122

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • New England Eye Center

    Boston, Massachusetts, 02111

  • National Retina Institute

    Chevy Chase, Maryland, 20815

  • The University of Chicago

    Chicago, Illinois, 60637

  • Retina Assocites of Cleveland, Inc.

    Cleveland, Ohio, 44107

  • Cleveland Clinical Foundation

    Cleveland, Ohio, 44195

  • Danbury Eye Physicians & Surgeons, P.C.

    Danbury, Connecticut, 06810

  • Kresge Eye Institute/Hutzel Hospital

    Detroit, Michigan, 48201

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33334

  • Vitreoretinal Consultants

    Houston, Texas, 77030

  • Midwest Eye Institute

    Indianapolis, Indiana, 46280

  • Illinois Retina Associates, S.C.

    Joliet, Illinois, 60435

  • Retina Associates

    Kansas City, Missouri, 64111

  • Retina Associates of Cleveland

    Lakewood, Ohio, 44107

  • University of Kentucky, The Kentucky Clinic

    Lexington, Kentucky, 40536

  • Retina Associates of Cleveland

    Lorain, Ohio, 44052

  • Retina Vitreous Associates Medical Group

    Los Angeles, California, 90017

  • Retina Associates of Cleveland

    Middleburg Heights, Ohio, 44130

  • Retina Associates of NJ

    Millburn, New Jersey, 07041

  • Medical College of Wisconsin/The Eye Institute

    Milwaukee, Wisconsin, 53226

  • NY Eye and Ear Infirmary

    New York, New York, 10003

  • Wagner Mandell Retina Center

    Norfolk, Virginia, 23505

  • Central Florida Retina

    Orlando, Florida, 32806

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Retina Consultants San Diego

    Poway, California, 92064

  • Carolina Eye Associates

    Southern Pines, North Carolina, 28387

  • Retina Associates of NJ

    Teaneck, New Jersey, 07666

  • Retina Center, P.C.

    Tucson, Arizona, 85704

  • Wagner Mandell Retina Center

    Virginia Beach, Virginia, 23454

  • Retina Associates of NJ

    Wayne, New Jersey, 07470

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
denufosol tetrasodium (INS37217) Intravitreal Injection
Keywords
rhegmatogenous retinal detachment, detached retina, retinal tear, retinal break
Medical subject headings
Retinal Detachment, Retinal Perforations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • denufosol tetrasodium (INS37217) Intravitreal InjectionDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo

  2. Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects

Secondary outcomes (2)

  1. Identify one or more dose levels of denufosol as safe and potentially effective to warrant study in Phase 3

  2. Evaluate utility of 3D B-scan ultrasound technology as endpoint for objectively describing volume of retinal detachment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionApr 2006
  4. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083967
Sponsor's protocol ID
06-102
Status last verified
Apr 2015
First submitted
3 Jun 2004
Last updated
10 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing denufosol tetrasodium (INS37217) Intravitreal Injection in people with Retinal Detachment, run by Merck Sharp & Dohme LLC at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00083967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.

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