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Monoclonal Antibodies

Bevacizumab for Retinopathy of Prematurity (ROP4 Trial)

Phase 2

Recruiting

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

Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes

Birth weight < 1251 grams

Must not have

Previous treatment for ROP

Stage 4 or 5 ROP in either eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate whether low-dose bevacizumab is effective in treating the most severe form of ROP, where all the ROP and retinal vessels are in zone I.

Who is the study for?

This trial is for premature babies with a birth weight under 1251 grams who have been newly diagnosed with severe type of retinopathy (eye disease) in zone I. Babies can't participate if they have other significant eye problems, previous ROP treatments, active infections around the eye, advanced stages of ROP, or if they cannot receive treatment within two days of diagnosis.

What is being tested?

The study is testing low doses of Bevacizumab (0.063 mg and 0.25mg) to see if it's effective for treating severe retinopathy in very young infants. It will also look at how well the retina's blood vessels develop after treatment compared to standard doses.

What are the potential side effects?

While specific side effects are not listed here, Bevacizumab may generally cause issues like inflammation in the body, potential impact on growth and development due to its effect on blood vessels, and possibly interfere with wound healing.

Eligibility Criteria

Inclusion Criteria

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

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I was recently diagnosed with a specific eye condition in the past 2 days.

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My birth weight was less than 1251 grams.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated for retinopathy of prematurity before.

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My eye condition is at stage 4 or 5 ROP.

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I have a major eye problem, like cataract.

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My doctor or my child's doctor is not open to random treatment assignment.

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I do not have an eye infection or blocked tear duct with pus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

posterior capsule opacification

vitreous syneresis

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Bevacizumab- 0.25 mgExperimental Treatment1 Intervention

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.

Group II: Bevacizumab- 0.063 mgExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

0 / 7Eligibility criteria met