Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity (BEAT-ROP)

May 8, 2017 updated by: Helen Mintz-Hittner, MD, The University of Texas Health Science Center, Houston

Intravitreal Bevacizumab (AvastinTM) Injections Versus Conventional Laser Surgery for Vision-threatening Retinopathy of Prematurity: a Prospective, Randomized, Non-blinded, Controlled, Multi-center, Clinical Trial

The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This phase 2 study assessed the anti-neovascularization activity of intravitreal bevacizumab, as determined by regression of neovascular vessels of retinopathy of prematurity (ROP), in neonates with acute stage 3 ROP in zone I or posterior zone II with plus disease. This study enrolled 150 confirmed cases of vision threatening ROP which have definite plus disease [ranging from Early Treatment for Retinopathy of Prematurity, to Cryotherapy for Retinopathy of Prematurity . This was done because of the controversy regarding determining plus disease and the increasing concern that many infants are being treated whose ROP would spontaneously regress. Bevacizumab will be administered intravitreally using 0.625 mg (0.025 ml) injections into each eye. There was no intent to give additional doses unless there was a recurrence of vision threatening stage 3 ROP with plus disease since the disease is self limited by completion of vascularization. Clinical response and any evidence of ocular toxicities were documented by retinal imaging system (manufactured by Clarity Medical Systems, Inc.) taken pre-injection, one week and one month post injection, and at 6 months of age (54 weeks postmenstrual age)(window of 50 to 70 weeks PMA)(primary outcome) and at 12 months of age (80 weeks postmenstrual age)(window of 75 to 100 weeks PMA)(structural documentation). Using the same retinal imaging system, fluorescein angiograms have been taken when possible to document structural outcomes in greater detail. No evidence of systemic toxicities were documented by appropriate clinical and laboratory tests.

Study Type

Interventional

Enrollment (Actual)

150

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 Locations

  • United States
    • California
      • Pasadena, California, United States, 91109
        • Huntington Memorial Hospital
    • Colorado
      • Denver, Colorado, United States, 80218
        • Presbyterian-St. Luke's Hospital
    • Illinois
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center-Children's Hospital of Illinois
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health Richland Hospital
      • Columbia, South Carolina, United States, 29223
        • Palmetto Health Baptist Hospital
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, United States, 75346
        • Baylor University Medical Center
      • El Paso, Texas, United States, 79902
        • Las Palmas Medical Center
      • El Paso, Texas, United States, 79905
        • R.E. Thomason Hospital
      • El Paso, Texas, United States, 79925
        • Del Sol Medical Center
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
      • Houston, Texas, United States, 77030
        • Children's Memorial Hermann Hospital
      • Houston, Texas, United States, 77002
        • St. Joseph Medical Center
      • Houston, Texas, United States, 77074
        • Memorial Hermann Southwest Hospital
      • Webster, Texas, United States, 77598
        • Clear Lake Regional Medical Center

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

4 weeks to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Infants who have been screened by the American Academy of Ophthalmology, the American Academy of Pediatrics, and the American Association for Pediatric Ophthalmology and Strabismus guidelines (≤1500 grams at birth and ≤30 weeks gestation) who develop Stage 3 ROP in zone I or posterior zone II.
  2. Informed Consent from a parent or guardian.

Exclusion Criteria:

  1. Infants who have a congenital systemic anomaly or have a congenital ocular abnormality.
  2. Infants who cannot be treated by conventional laser therapy because of problems with media clarity. Generally, blind external cryotherapy would be utilized as an initial therapy and the infant would be excluded from the study even if the media clear subsequently.
  3. Informed Consent from a parent or guardian refused. This will mean that an infant automatically will receive laser therapy. Bevacizumab (Avastin®) treatment cannot be given outside of the Protocol. No data will be used from an infant without Informed Consent.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab for ROP
Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study
Drug: Bevacizumab
Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.
Other Names:
  • Avastin; Monoclonal antibody
Active Comparator: Conventional Laser for ROP
Conventional Laser to the Peripheral Retina is the Control Arm of this Study
Procedure: Conventional Laser for ROP
Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)
Other Names:
  • Diode Laser is the laser utilized for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment
Time Frame: 54 weeks postmenstrual age (window of 50 to 70 weeks)

For Bevacizumab: Regrowth of new vessels at the site of the original extraretinal fibrovascular proliferation and/or at the site of the anterior edge of inner retinal vascularization.

For Laser: Regrowth of new vessels from the vessels at the anterior edge of inner retinal vascularization (remaining after retinal ablation).
54 weeks postmenstrual age (window of 50 to 70 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myopia in Zone I and Posterior Zone II of Infant Eyes
Time Frame: 2.5 years of age
Myopia was determined via refraction using a retinoscope and lenses. Myopia is defined as a refractive error reported in Diopters.
2.5 years of age
Visual Acuity
Time Frame: Age 7 years.
The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.
Age 7 years.

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Helen A. Mintz-Hittner, M.D., The University of Texas Health Science Center, Houston

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.

General Publications

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)

March 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-08-0036
  • IND: 101,578 (Other Identifier: Research to Prevent Blindness (NY, NY))

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.

Clinical Trials on Retinopathy of Prematurity

Clinical Trials on Bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe