ACTIVE_NOT_RECRUITING

Bevacizumab Treatment For Type 1 ROP

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.

Official Title

Bevacizumab Treatment For Type 1 Retinopathy of Prematurity

Quick Facts

Study Start:2022-05-18
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04634578

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.

Ages Eligible for Study:Not specified to 6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Birth weight \< 1251 grams
  2. 2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes
  1. 1. Previous treatment for ROP
  2. 2. Stage 4 or 5 ROP in either eye
  3. 3. Treatment could not be done within 2 days of diagnosis of type 1 ROP
  4. 4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
  5. 5. Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits.
  6. 6. Active ocular infection or purulent nasolacrimal duct obstruction in either eye
  7. * Visually significant ocular anomaly (e.g., cataract, coloboma)
  8. * Opacity that precludes an adequate view of the retina

Contacts and Locations

Principal Investigator

David K Wallace, MD, MPH
STUDY_CHAIR
Vanderbilt University

Study Locations (Sites)

Arkansas Childrens Hospital/ University of Arkansas Medical Sciences
Little Rock, Arkansas, 72202
United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, 92697
United States
Jules Stein Eye Institute at the University of California, Los Angeles
Los Angeles, California, 90095
United States
University of California, Davis
Sacramento, California, 95817
United States
University of California San Francisco Department of Ophthalmology
San Francisco, California, 94143
United States
The Emory Eye Center
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
U of Illinois at Chicago Eye and Ear Infirmary
Chicago, Illinois, 60612
United States
University of Chicago
Hyde Park, Illinois, 60637
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
UK Ophthalmology and Visual Sciences, The Eye Clinic
Lexington, Kentucky, 40508
United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204-5809
United States
Boston Children's Hospital
Boston, Massachusetts, 02215
United States
New York Presbyterian David H Koch Center
New York, New York, 10065
United States
Duke University Eye Center
Durham, North Carolina, 27710
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, 43205
United States
Casey Eye Institute
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Storm Eye Institute
Mt. Pleasant, South Carolina, 29464
United States
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, 77030
United States
University of Utah Moran Eye Center
Salt Lake City, Utah, 84132
United States
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502
United States

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

  • David K Wallace, MD, MPH, STUDY_CHAIR, Vanderbilt University

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 Registration Dates

Study Start Date2022-05-18
Study Completion Date2027-07

Study Record Updates

Study Start Date2022-05-18
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Retinopathy of Prematurity