Bevacizumab Treatment For Type 1 ROP (ROP4)

February 6, 2024 updated by: Jaeb Center for Health Research

Bevacizumab Treatment For Type 1 Retinopathy of Prematurity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or either intravitreous bevacizumab 0.25 mg. Study exams will be at 1 day, 4 days (if no improvement on day 1), 1, 2, 3, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). Additional study exams will occur at adjusted age 6 and 12 months. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success within each dose group, defined as improvement by the day 4 exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. Important secondary outcomes include safety and efficacy. refractive outcomes, and the extent of retinal vascularization at 2 and 4 months post-injection between the two dose groups.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada
        • Not yet recruiting
        • Surrey Memorial Hospital
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Not yet recruiting
        • IWK Health Centre
        • Contact:
          • Johane M Robitaille, MD
          • Phone Number: 902-470-8731
          • Email: jrobitai@dal.ca
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Not yet recruiting
        • The Hospital for Sick Children
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Childrens Hospital/ University of Arkansas Medical Sciences
        • Contact:
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • Univ of California, Irvine- Gavin Herbert Eye Institute
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Jules Stein Eye Institute at the University of California, Los Angeles
        • Contact:
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • University of California, Davis
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco Department of Ophthalmology
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80204
        • Not yet recruiting
        • Denver Health and Hospital Authority
        • Contact:
    • Connecticut
      • Farmington, Connecticut, United States, 06032
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • The Emory Eye Center
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Hawke H Yoon, MD
        • Sub-Investigator:
          • Safa Rahmani, MD
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • U of Illinois at Chicago Eye and Ear Infirmary
        • Contact:
      • Hyde Park, Illinois, United States, 60637
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
        • Contact:
          • David K Wallace, MD, MPH
          • Phone Number: 317-278-2651
          • Email: dwallac@iu.edu
        • Principal Investigator:
          • David K Wallace, MD, MPH
      • Indianapolis, Indiana, United States, 46202
        • Not yet recruiting
        • Riley Hospital for Children
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • UK Ophthalmology and Visual Sciences, The Eye Clinic
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21204-5809
        • Recruiting
        • Greater Baltimore Medical Center
        • Contact:
    • Massachusetts
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Not yet recruiting
        • University of Missouri- Columbia Mason Eye Institute
        • Contact:
      • Saint Louis, Missouri, United States, 63104
        • Not yet recruiting
        • St. Louis University Ophthalmology
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian David H Koch Center
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • University of North Carolina
        • Contact:
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Eye Center
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
        • Contact:
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Pediatric Ophthalmology Associates, Inc.
        • Contact:
        • Sub-Investigator:
          • Amanda L Way, MD
        • Principal Investigator:
          • Catherine O Jordan, MD
        • Sub-Investigator:
          • Hilliary E Inger, MD
        • Sub-Investigator:
          • Mary Lou McGregor, MD
        • Sub-Investigator:
          • Richard P Golden, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Casey Eye Institute
        • Contact:
          • J. Campbell
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15224
        • Not yet recruiting
        • UPMC Children's Eye Center of Children's Hospital of Pittsburgh
        • Contact:
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Recruiting
        • Storm Eye Institute
        • Contact:
          • James Bowsher
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital - Dept. Of Ophthalmology
        • Contact:
      • Houston, Texas, United States, 77054
        • Not yet recruiting
        • The Woman's Hospital of Texas
        • Contact:
      • Lubbock, Texas, United States, 79424
        • Not yet recruiting
        • Texas Retina Associates
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Moran Eye Center
        • Contact:
        • Sub-Investigator:
          • Griffin Jardine, MD
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Pediatric Eye Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:

  1. Birth weight < 1251 grams
  2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will be excluded from study participation.

  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

One eye will be excluded, and other eye may be eligible, if either of the following are present:

  • Visually significant ocular anomaly (e.g., cataract, coloboma)
  • Opacity that precludes an adequate view of the retina

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab- 0.063 mg
Participants will receive a single intravitreal injection of 0.063 mg of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.
Drug: Bevacizumab

All participants will receive a single intravitreal injection of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.

Eyes meeting eligibility criteria will receive a single dose of 0.063 mg or 0.25mg bevacizumab provided by the pharmacy at the investigator's institution.

Other Names:
  • Avastin
Experimental: Bevacizumab- 0.25 mg
Participants will receive a single intravitreal injection of 0.25 mg of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.
Drug: Bevacizumab

All participants will receive a single intravitreal injection of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.

Eyes meeting eligibility criteria will receive a single dose of 0.063 mg or 0.25mg bevacizumab provided by the pharmacy at the investigator's institution.

Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Success at 4 Weeks Post Injection
Time Frame: 4 weeks

Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria:

  • Improvement by the 4-day exam (3 to 5 days)
  • No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

National Eye Institute (NEI)
Pediatric Eye Disease Investigator Group

Investigators

  • Study Chair: David K Wallace, MD, MPH, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

May 18, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROP4
  • UG1EY011751 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.

IPD Sharing Time Frame

Data will be made available after publication of each primary manuscript.

IPD Sharing Access Criteria

Users accessing the data must enter an email address.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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