Bevacizumab Treatment For Type 1 ROP

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.

Conditions

Retinopathy of Prematurity

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Study Overview

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Study Details

Study overview

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.

Bevacizumab Treatment For Type 1 Retinopathy of Prematurity

Bevacizumab Treatment For Type 1 ROP

Condition
Retinopathy of Prematurity
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Childrens Hospital/ University of Arkansas Medical Sciences, Little Rock, Arkansas, United States, 72202

Irvine

Univ of California, Irvine- Gavin Herbert Eye Institute, Irvine, California, United States, 92697

Los Angeles

Jules Stein Eye Institute at the University of California, Los Angeles, Los Angeles, California, United States, 90095

Sacramento

University of California, Davis, Sacramento, California, United States, 95817

San Francisco

University of California San Francisco Department of Ophthalmology, San Francisco, California, United States, 94143

Denver

Denver Health and Hospital Authority, Denver, Colorado, United States, 80204

Farmington

Connecticut Childrens Medical Center, Farmington, Connecticut, United States, 06032

Atlanta

The Emory Eye Center, Atlanta, Georgia, United States, 30322

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Chicago

U of Illinois at Chicago Eye and Ear Infirmary, Chicago, Illinois, United States, 60612

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Birth weight \< 1251 grams
  • 2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes
  • 1. Previous treatment for ROP
  • 2. Stage 4 or 5 ROP in either eye
  • 3. Treatment could not be done within 2 days of diagnosis of type 1 ROP
  • 4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
  • 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. Active ocular infection or purulent nasolacrimal duct obstruction in either eye
  • * Visually significant ocular anomaly (e.g., cataract, coloboma)
  • * Opacity that precludes an adequate view of the retina

Ages Eligible for Study

to 6 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jaeb Center for Health Research,

David K Wallace, MD, MPH, STUDY_CHAIR, Indiana University

Study Record Dates

2027-07