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Retinopathy of PrematurityPhase 2/3NCT00027222

The Early Treatment for Retinopathy of Prematurity Study (ETROP)

A Phase 2/3 study testing retinal ablation in people with Retinopathy of Prematurity, run by National Eye Institute (NEI) at 26 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 0 years to 42 days
Conditions the study is for
Retinopathy of Prematurity
What is being tested?
retinal ablation
Type of treatment
Surgery or procedure
How many people
Not given
Where
26 sitesUnited States
Study dates
Oct 2001to not given
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years to 42 days
  • All sexes
  • No healthy volunteers
  • Child

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).

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201-1595

  • The Zanvyl Krieger Children's Eye Center

    Baltimore, Maryland, 21287

  • Tufts University School of Medicine Department of Pediatrics

    Boston, Massachusetts, 02111

  • The Children's Hospital of Buffalo Department of Ophthalmology

    Buffalo, New York, 14222-2099

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-2236

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

    Chicago, Illinois, 60612-724

  • Columbus Children's Hospital

    Columbus, Ohio, 43205

  • Pediatric Ophthalmology Associates, PC

    Dearborn, Michigan, 48124

  • Duke University Eye Center

    Durham, North Carolina, 27710

  • Baylor College of Medicine Feigin Center

    Houston, Texas, 77030

  • Indiana University Department of Pediatrics

    Indianapolis, Indiana, 46002-2119

  • University of Louisville Health Sciences Center

    Louisville, Kentucky, 40202-1594

  • University of Minnesota

    Minneapolis, Minnesota, 55455-0591

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112-2699

  • Edward S. Harkness Eye Institute

    New York, New York, 10032

  • The Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Stanford University School of Medicine

    Palo Alto, California, 94304

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

    Philadelphia, Pennsylvania, 19104-4399

  • Magee-Women's Hospital

    Pittsburgh, Pennsylvania, 15213-3180

  • Oregon Health Sciences University Casey Eye Institute

    Portland, Oregon, 97201-4197

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • John Moran Eye Center University of Utah Health Sciences Center

    Salt Lake City, Utah

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Smith-Kettlewell Eye Research Institute

    San Francisco, California, 94115-1813

  • Eastern Long Island Retina Associate

    Shirley, New York, 111967

  • Cardinal Glennon Children's Hospital Neonatology Office

    St Louis, Missouri, 63104

Other trials in United States

About this study

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.

Read the 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.

Being tested
retinal ablation
Medical subject headings
Retinopathy of Prematurity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • retinal ablationProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2001 (estimated)
  2. Study startOct 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00027222
Sponsor's protocol ID
NEI-83
Status last verified
Dec 2003
First submitted
28 Nov 2001
Last updated
24 Jun 2005
Results posted
No

Publications

  • 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.

    PubMed 22892757

  • 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.

    PubMed 22232483

  • 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.

    PubMed 22153396

  • 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.

    PubMed 21746974

  • 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.

    PubMed 21320954

  • 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.

    PubMed 20385942

  • 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.

    PubMed 20385926

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing retinal ablation in people with Retinopathy of Prematurity, run by National Eye Institute (NEI) at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00027222, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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