The Early Treatment for Retinopathy of Prematurity Study (ETROP)

June 23, 2005 updated by: National Eye Institute (NEI)
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Investigators

  • Study Chair: William V. Good, M.D., Smith-Kettlewell Eye Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Registration Dates

First Submitted

November 28, 2001

First Submitted That Met QC Criteria

October 26, 2001

First Posted (Estimate)

October 29, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-83

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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