The Early Treatment for Retinopathy of Prematurity Study (ETROP)

Last updated: June 23, 2005
Sponsor: National Eye Institute (NEI)
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Retina

Myopic Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT00027222
NEI-83
  • Ages < 42
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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).

Study Design

Study Start date:
October 01, 2001
Estimated Completion Date:

Study 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.

Connect with a study center

  • Stanford University School of Medicine

    Palo Alto, California 94304
    United States

    Site Not Available

  • Smith-Kettlewell Eye Research Institute

    San Francisco, California 94115-1813
    United States

    Site Not Available

  • UIC Eye Center Department of Ophthalmology and Visual Sciences The Lions of Illinois Eye Research Institute

    Chicago, Illinois 60612-724
    United States

    Site Not Available

  • Indiana University Department of Pediatrics

    Indianapolis, Indiana 46002-2119
    United States

    Site Not Available

  • University of Louisville Health Sciences Center

    Louisville, Kentucky 40202-1594
    United States

    Site Not Available

  • Tulane University Medical Center

    New Orleans, Louisiana 70112-2699
    United States

    Site Not Available

  • The Zanvyl Krieger Children's Eye Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201-1595
    United States

    Site Not Available

  • Tufts University School of Medicine Department of Pediatrics

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Pediatric Ophthalmology Associates, PC

    Dearborn, Michigan 48124
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455-0591
    United States

    Site Not Available

  • Cardinal Glennon Children's Hospital Neonatology Office

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • The Children's Hospital of Buffalo Department of Ophthalmology

    Buffalo, New York 14222-2099
    United States

    Site Not Available

  • Edward S. Harkness Eye Institute

    New York, New York 10032
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Eastern Long Island Retina Associate

    Shirley, New York 111967
    United States

    Site Not Available

  • Duke University Eye Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Columbus Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • The Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oregon Health Sciences University Casey Eye Institute

    Portland, Oregon 97201-4197
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia Division of Pediatric Ophthalmology

    Philadelphia, Pennsylvania 19104-4399
    United States

    Site Not Available

  • Magee-Women's Hospital

    Pittsburgh, Pennsylvania 15213-3180
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425-2236
    United States

    Site Not Available

  • Baylor College of Medicine Feigin Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229-3900
    United States

    Site Not Available

  • John Moran Eye Center University of Utah Health Sciences Center

    Salt Lake City, Utah
    United States

    Site Not Available

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