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Monoclonal Antibodies

Bevacizumab for ROP for Retinopathy of Prematurity (BEAT-ROP Trial)

Phase 2
Waitlist Available
Led By Helen A. Mintz-Hittner, M.D.
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Informed Consent from a parent or guardian.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years of age
Awards & highlights

BEAT-ROP Trial Summary

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.

Eligible Conditions
  • Retinopathy of Prematurity

BEAT-ROP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

BEAT-ROP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment
Secondary outcome measures
Myopia in Zone I and Posterior Zone II of Infant Eyes
Visual Acuity

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

BEAT-ROP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bevacizumab for ROPExperimental Treatment1 Intervention
Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study
Group II: Conventional Laser for ROPActive Control1 Intervention
Conventional Laser to the Peripheral Retina is the Control Arm of this Study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,971 Total Patients Enrolled
1 Trials studying Retinopathy of Prematurity
23 Patients Enrolled for Retinopathy of Prematurity
Helen A. Mintz-Hittner, M.D.Principal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~9 spots leftby Mar 2025