The Early Treatment for Retinopathy of Prematurity Study (ETROP)

Retinopathy of Prematurity Clinical Trial

Official title:

The Early Treatment for Retinopathy of Prematurity Study (ETROP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00027222
• Other study ID #: NEI-83
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 28, 2001
• Last updated: June 23, 2005
• Start date: October 2001

Study information

• Verified date: December 2003
• Source: National Eye Institute (NEI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 42 Days

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Procedure:
• retinal ablation

Locations

Country	Name	City	State
United States	The Zanvyl Krieger Children's Eye Center	Baltimore	Maryland
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Tufts University School of Medicine Department of Pediatrics	Boston	Massachusetts
United States	The Children's Hospital of Buffalo Department of Ophthalmology	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UIC Eye Center Department of Ophthalmology and Visual Sciences The Lions of Illinois Eye Research Institute	Chicago	Illinois
United States	Columbus Children's Hospital	Columbus	Ohio
United States	Pediatric Ophthalmology Associates, PC	Dearborn	Michigan
United States	Duke University Eye Center	Durham	North Carolina
United States	Baylor College of Medicine Feigin Center	Houston	Texas
United States	Indiana University Department of Pediatrics	Indianapolis	Indiana
United States	University of Louisville Health Sciences Center	Louisville	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	Edward S. Harkness Eye Institute	New York	New York
United States	The Dean A. McGee Eye Institute	Oklahoma City	Oklahoma
United States	Stanford University School of Medicine	Palo Alto	California
United States	The Children's Hospital of Philadelphia Division of Pediatric Ophthalmology	Philadelphia	Pennsylvania
United States	Magee-Women's Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University Casey Eye Institute	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	John Moran Eye Center University of Utah Health Sciences Center	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Smith-Kettlewell Eye Research Institute	San Francisco	California
United States	Eastern Long Island Retina Associate	Shirley	New York
United States	Cardinal Glennon Children's Hospital Neonatology Office	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States,