NCT00083967

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

33 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

June 3, 2004

Last Update Submit

April 9, 2015

Conditions

Retinal Detachment

Keywords

rhegmatogenous retinal detachmentdetached retinaretinal tearretinal break

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Interventions

denufosol tetrasodium (INS37217) Intravitreal InjectionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Retina Center, P.C.

Tucson, Arizona, 85704, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Retina Vitreous Associates Medical Group

Los Angeles, California, 90017, United States

Location

Retina Consultants San Diego

Poway, California, 92064, United States

Location

Danbury Eye Physicians & Surgeons, P.C.

Danbury, Connecticut, 06810, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33334, United States

Location

Central Florida Retina

Orlando, Florida, 32806, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Illinois Retina Associates, S.C.

Joliet, Illinois, 60435, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46280, United States

Location

University of Kentucky, The Kentucky Clinic

Lexington, Kentucky, 40536, United States

Location

Maine Vitreoretinal Consultants

Bangor, Maine, 04401, United States

Location

National Retina Institute

Chevy Chase, Maryland, 20815, United States

Location

New England Eye Center

Boston, Massachusetts, 02111, United States

Location

Kresge Eye Institute/Hutzel Hospital

Detroit, Michigan, 48201, United States

Location

Retina Associates

Kansas City, Missouri, 64111, United States

Location

Retina Associates of NJ

Millburn, New Jersey, 07041, United States

Location

Retina Associates of NJ

Teaneck, New Jersey, 07666, United States

Location

Retina Associates of NJ

Wayne, New Jersey, 07470, United States

Location

NY Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Carolina Eye Associates

Southern Pines, North Carolina, 28387, United States

Location

Retina Associates of Cleveland

Beachwood, Ohio, 44122, United States

Location

Retina Assocites of Cleveland, Inc.

Cleveland, Ohio, 44107, United States

Location

Cleveland Clinical Foundation

Cleveland, Ohio, 44195, United States

Location

Retina Associates of Cleveland

Lakewood, Ohio, 44107, United States

Location

Retina Associates of Cleveland

Lorain, Ohio, 44052, United States

Location

Retina Associates of Cleveland

Middleburg Heights, Ohio, 44130, United States

Location

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Austin Retina

Austin, Texas, 78705, United States

Location

Vitreoretinal Consultants

Houston, Texas, 77030, United States

Location

Wagner Mandell Retina Center

Norfolk, Virginia, 23505, United States

Location

Wagner Mandell Retina Center

Virginia Beach, Virginia, 23454, United States

Location

Medical College of Wisconsin/The Eye Institute

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Retinal DetachmentRetinal Perforations

Interventions

denufosol tetrasodiumIntravitreal Injections

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Amy Schaberg, BSN

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2004

First Posted

June 7, 2004

Study Start

June 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

US(33)