NCT00027222

Brief 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.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

26 active sites

Status
unknown

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

October 1, 2001

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 29, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 28, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

November 28, 2001

Last Update Submit

June 23, 2005

Conditions

Interventions

Eligibility Criteria

Age0 Years - 42 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (26)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

Smith-Kettlewell Eye Research Institute

San Francisco, California, 94115-1813, United States

Location

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

Chicago, Illinois, 60612-724, United States

Location

Indiana University Department of Pediatrics

Indianapolis, Indiana, 46002-2119, United States

Location

University of Louisville Health Sciences Center

Louisville, Kentucky, 40202-1594, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112-2699, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1595, United States

Location

The Zanvyl Krieger Children's Eye Center

Baltimore, Maryland, 21287, United States

Location

Tufts University School of Medicine Department of Pediatrics

Boston, Massachusetts, 02111, United States

Location

Pediatric Ophthalmology Associates, PC

Dearborn, Michigan, 48124, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455-0591, United States

Location

Cardinal Glennon Children's Hospital Neonatology Office

St Louis, Missouri, 63104, United States

Location

The Children's Hospital of Buffalo Department of Ophthalmology

Buffalo, New York, 14222-2099, United States

Location

Edward S. Harkness Eye Institute

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Eastern Long Island Retina Associate

Shirley, New York, 111967, United States

Location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Columbus Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health Sciences University Casey Eye Institute

Portland, Oregon, 97201-4197, United States

Location

The Children's Hospital of Philadelphia Division of Pediatric Ophthalmology

Philadelphia, Pennsylvania, 19104-4399, United States

Location

Magee-Women's Hospital

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-2236, United States

Location

Baylor College of Medicine Feigin Center

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

John Moran Eye Center University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Location

Related Publications (7)

  • Wallace DK, Bremer DL, Good WV, Fellows R, Summers CG, Tung B, Hardy RJ. Correlation of recognition visual acuity with posterior retinal structure in advanced retinopathy of prematurity. Arch Ophthalmol. 2012 Dec;130(12):1512-6. doi: 10.1001/archophthalmol.2012.2118.

  • Good WV, Hardy RJ, Wallace DK, Bremer D, Rogers DL, Siatkowski RM, De Becker I, Summers CG, Fellows R, Tung B, Palmer EA. beta-Blocking and racial variation in the severity of retinopathy of prematurity. Arch Ophthalmol. 2012 Jan;130(1):117-8. doi: 10.1001/archopht.130.1.117. No abstract available.

  • VanderVeen DK, Bremer DL, Fellows RR, Hardy RJ, Neely DE, Palmer EA, Rogers DL, Tung B, Good WV; Early Treatment for Retinopathy of Prematurity Cooperative Group. Prevalence and course of strabismus through age 6 years in participants of the Early Treatment for Retinopathy of Prematurity randomized trial. J AAPOS. 2011 Dec;15(6):536-40. doi: 10.1016/j.jaapos.2011.07.017.

  • Early Treatment for Retinopathy of Prematurity Cooperative Group; Dobson V, Quinn GE, Summers CG, Hardy RJ, Tung B, Good WV. Grating visual acuity results in the early treatment for retinopathy of prematurity study. Arch Ophthalmol. 2011 Jul;129(7):840-6. doi: 10.1001/archophthalmol.2011.143.

  • Quinn GE, Dobson V, Hardy RJ, Tung B, Palmer EA, Good WV; Early Treatment for Retinopathy of Prematurity Cooperative Group. Visual field extent at 6 years of age in children who had high-risk prethreshold retinopathy of prematurity. Arch Ophthalmol. 2011 Feb;129(2):127-32. doi: 10.1001/archophthalmol.2010.360.

  • Christiansen SP, Dobson V, Quinn GE, Good WV, Tung B, Hardy RJ, Baker JD, Hoffman RO, Reynolds JD, Rychwalski PJ, Shapiro MJ; Early Treatment for Retinopathy of Prematurity Cooperative Group. Progression of type 2 to type 1 retinopathy of prematurity in the Early Treatment for Retinopathy of Prematurity Study. Arch Ophthalmol. 2010 Apr;128(4):461-5. doi: 10.1001/archophthalmol.2010.34.

  • Early Treatment for Retinopathy of Prematurity Cooperative Group; Good WV, Hardy RJ, Dobson V, Palmer EA, Phelps DL, Tung B, Redford M. Final visual acuity results in the early treatment for retinopathy of prematurity study. Arch Ophthalmol. 2010 Jun;128(6):663-71. doi: 10.1001/archophthalmol.2010.72. Epub 2010 Apr 12.

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • William V. Good, M.D.

    Smith-Kettlewell Eye Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 28, 2001

First Posted

October 29, 2001

Study Start

October 1, 2001

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations