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Monoclonal Antibodies

Bevacizumab vs Laser for Retinopathy of Prematurity (ROP3 Trial)

Phase 3
Waitlist Available
Research Sponsored by Jaeb Center for Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months adjusted age
Awards & highlights

ROP3 Trial Summary

This trial will compare two treatments for retinopathy of prematurity (ROP), a common eye condition in premature babies. One treatment is a low dose of the drug bevacizumab, while the other is laser photocoagulation. The study will also look at the effects of these treatments on the baby's later development, including their vision.

Eligible Conditions
  • Retinopathy of Prematurity

ROP3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months adjusted age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months adjusted 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
Treatment Success Rate At 6 Months Adjusted Age

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

ROP3 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BevacizumabExperimental Treatment1 Intervention
For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated.
Group II: LaserActive Control1 Intervention
For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by Occupational Safety and Health Administration (OSHA) and facility standards, will be followed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,978 Total Patients Enrolled
15 Trials studying Retinopathy of Prematurity
4,642 Patients Enrolled for Retinopathy of Prematurity
Jaeb Center for Health ResearchLead Sponsor
152 Previous Clinical Trials
34,718 Total Patients Enrolled
2 Trials studying Retinopathy of Prematurity
200 Patients Enrolled for Retinopathy of Prematurity
Pediatric Eye Disease Investigator GroupNETWORK
17 Previous Clinical Trials
4,248 Total Patients Enrolled
2 Trials studying Retinopathy of Prematurity
200 Patients Enrolled for Retinopathy of Prematurity

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04634604 — Phase 3
Retinopathy of Prematurity Research Study Groups: Laser, Bevacizumab
Retinopathy of Prematurity Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT04634604 — Phase 3
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634604 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any similar research projects to Bevacizumab?

"As of right now, there are 378 clinical trials ongoing that involve Bevacizumab with 99 of them being in Phase 3. At the moment, many of the clinical trials for Bevacizumab are situated in Taibei, Taiwan, but there are a total of 18919 locations running studies for Bevacizumab."

Answered by AI

How many patients are currently included in this research project?

"In order to run this clinical trial, 212 patients that meet the inclusion criteria are needed. Some of the participating sites for this trial include IWK Health Centre in Halifax, Nova Scotia and St. Louis University Ophthalmology in Saint Louis, Missouri."

Answered by AI

Are there any other trial sites open in Canada right now?

"Currently, this study is looking for 35 more patients. The potential participants can be found at IWK Health Centre in Halifax, St. Louis University Ophthalmology in Saint Louis, and UPMC Children's Eye Center of Children's Hospital of Pittsburgh in Pittsburgh, as well as 35 other locations."

Answered by AI

What is the mortality rate associated with Bevacizumab?

"Earlier clinical trials have shown some efficacy for Bevacizumab, and it has undergone multiple rounds of testing for safety, so it receives a 3 on our Power scale."

Answered by AI

What are the most common diagnoses associated with Bevacizumab?

"Bevacizumab is most often used to treat malignant neoplasms, but can also be employed against other conditions like stage iv epithelial ovarian cancer, recurrent platinum sensitive primary peritoneal cancer, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
2022. "A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04634604.
~5 spots leftby Apr 2025
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