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The Early Treatment for Retinopathy of Prematurity Study (ETROP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Eye Institute (NEI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00027222
First received: November 28, 2001
Last updated: June 23, 2005
Last verified: December 2003
  Purpose

The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to test the hypothesis that earlier treatment in carefully selected cases will result in an overall better visual outcome than treatment at the conventional CRYO-ROP threshold point in the disease.


Condition Intervention Phase
Retinopathy of Prematurity
Procedure: retinal ablation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: The Early Treatment for Retinopathy of Prematurity Study (ETROP)

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Study Start Date: October 2001
Detailed Description:

At age 5 1/2 years, the oldest age for which follow-up data are available, children with threshold ROP who were enrolled in the Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) -- Outcome Study showed fewer treated eyes (31.5 percent) than control eyes (48 percent) that were blind (P<0.001). Of those eyes that had a favorable structural outcome, with or without retinal ablation (cryotherapy to destroy the fringe of the retina through freezing), only a small percentage had best corrected visual acuity better than or equal to 20/40 at age 5 1/2 years (13 percent in the treated group; 17 percent in the untreated control group (P=0.19)). Among the 1398 followed from the 5 large natural history centers of the CRYO-ROP follow-up study, children with retinal residua of ROP (structural changes) had measurable visual acuity that was severly affected and tended to worsen with age. The CRYO-ROP Study proved conclusively that peripheral retinal ablation improves the chances of avoiding blindness, but at least 80 percent of eyes are left with acuity less than 20/40.

Two concerns emerged from the CRYO-ROP extensive study on the natural history of ROP and treatment of threshold ROP. The first of these is failure of peripheral retinal ablation to eliminate all, or nearly all cases, of retinal detachment due to ROP. In the CRYO-ROP Study, 26 percent of eyes with threshold disease in zone II and 78 percent of eyes with zone I threshold disease had an unfavorable structural outcome despite treatment. The second concern is that most children who developed threshold ROP disease had visual acuity worse than 20/40 even if the eye had a favorable structural outcome.

Since no other treatment has yet been shown to be effective in preventing blindness from ROP, retinal ablation remains the treatment of choice. The ETROP Study will test whether earlier treatment is more effective than treatment at threshold in improving functional (visual acuity) outcome following ROP, as well as determining whether earlier treatment decreases the probability of an unfavorable structural outcome.

Earlier treatment is defined as retinal ablation administered to the avascular retina when an eye reaches high risk prethreshold retinopathy of prematurity (ROP). Prethreshold indicates any Zone I ROP; or Zone II stage 2 with plus disease, or stage 3; or Zone II with less than 5 contiguous or 8 cumulative clock hours of stage 3 ROP with plus disease. Recognizing that a substantial number of eyes undergo spontaneous resolution of ROP, eyes will be randomized to early treatment only when high risk for an unfavorable visual acuity outcome is identified. High risk will be determined using a risk model analysis program based on longitudinal natural history data obtained from the CRYO-ROP study. This model integrates risk factors to assign a risk of progression to blindness without treatment. These factors include birth weight, gestational age, ethnicity, singleton/multiple status, outborn status, Zone on first exam, severity of ROP and rate of progression of ROP. When an infant develops prethreshold ROP and greater than or equal to 15 percent risk of unfavorable outcome, randomization to early treatment of one eye will occur. Visual acuity outcome will be measured by masked observers after wearing best correction using the Teller Acuity Card Procedure at 9 months corrected age.

  Eligibility

Ages Eligible for Study:   up to 42 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Infants <1251 grams birthweight born at participating centers and/or examined by 42 days of life are eligible. The early treatment trial requires that an infant have prethreshold retinopathy of prematurity (ROP).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027222

  Hide Study Locations
Locations
United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Smith-Kettlewell Eye Research Institute
San Francisco, California, United States, 94115-1813
United States, Illinois
UIC Eye Center Department of Ophthalmology and Visual Sciences The Lions of Illinois Eye Research Institute
Chicago, Illinois, United States, 60612-724
United States, Indiana
Indiana University Department of Pediatrics
Indianapolis, Indiana, United States, 46002-2119
United States, Kentucky
University of Louisville Health Sciences Center
Louisville, Kentucky, United States, 40202-1594
United States, Louisiana
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112-2699
United States, Maryland
The Zanvyl Krieger Children's Eye Center
Baltimore, Maryland, United States, 21287
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201-1595
United States, Massachusetts
Tufts University School of Medicine Department of Pediatrics
Boston, Massachusetts, United States, 02111
United States, Michigan
Pediatric Ophthalmology Associates, PC
Dearborn, Michigan, United States, 48124
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455-0591
United States, Missouri
Cardinal Glennon Children's Hospital Neonatology Office
St. Louis, Missouri, United States, 63104
United States, New York
The Children's Hospital of Buffalo Department of Ophthalmology
Buffalo, New York, United States, 14222-2099
Edward S. Harkness Eye Institute
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
Eastern Long Island Retina Associate
Shirley, New York, United States, 111967
United States, North Carolina
Duke University Eye Center
Durham, North Carolina, United States, 27710
United States, Ohio
Columbus Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oklahoma
The Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health Sciences University Casey Eye Institute
Portland, Oregon, United States, 97201-4197
United States, Pennsylvania
The Children's Hospital of Philadelphia Division of Pediatric Ophthalmology
Philadelphia, Pennsylvania, United States, 19104-4399
Magee-Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-2236
United States, Texas
Baylor College of Medicine Feigin Center
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
United States, Utah
John Moran Eye Center University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Sponsors and Collaborators
Investigators
Study Chair: William V. Good, M.D. Smith-Kettlewell Eye Research Institute
  More Information

No publications provided by National Eye Institute (NEI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00027222     History of Changes
Other Study ID Numbers: NEI-83
Study First Received: November 28, 2001
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases

ClinicalTrials.gov processed this record on November 20, 2014