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Monoclonal Antibodies

Bevacizumab for Retinopathy of Prematurity (ROP4 Trial)

Q: Can new patients still enroll in this research project?

Yes, the information on clinicaltrials.gov points out that this study is presently recruiting patients. The clinical trial was initially posted on 5/18/2022 and was last edited on 10/18/2022. The study is admitting 80 patients across 36 sites in order to further test the efficacy of the proposed intervention.

Q: What has been the most common side effect in people who have taken Bevacizumab?

While there is some evidence to support Bevacizumab's safety, it only received a score of 2 because this is still considered an early-stage medication with no Phase 3 data.

Q: How many participants will this clinical trial have in total?

In order to move forward, this clinical study requires 80 volunteers that fit the pre-determined inclusion criteria. greater Baltimore Medical Center in <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a> and University of Chicago in <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a> are two sites where patients can take part in the trial.

Q: Are there many places in Canada where this clinical trial is taking place?

This particular trial is being conducted in 36 hospitals, with a few notable locations including the Greater Baltimore Medical Center in <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>, United States of America and the University of <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>- Columbia Mason Eye Institute in Missouri.

Q: Could you provide a brief overview of other research projects that have included Bevacizumab?

There are a total of 375 clinical trials investigating bevacizumab. Of these, 99 are in Phase 3. Most of the research is being conducted in Taibei, Taiwan; however, there are 18908 locations worldwide where studies related to this treatment are taking place.

Q: What is the medicine Bevacizumab used to heal?

Bevacizumab is frequently used to treat cancer. Additionally, it can be helpful for patients with recurrent platinum sensitive primary peritoneal cancer, stage iv epithelial <a href="https://www.withpower.com/clinical-trials/ovarian-cancer">ovarian cancer</a> who have undergone initial surgery, and locally advanced nonsquamous non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

ROP4 Trial 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.Check my eligibility

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.See study design

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.

ROP4 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My birth weight was less than 1251 grams.

ROP4 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

bradycardia

pneumonia

pyelonephritis

colon cancer

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

ROP4 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

~5280

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH

547 Previous Clinical Trials

1,401,963 Total Patients Enrolled

15 Trials studying Retinopathy of Prematurity

4,578 Patients Enrolled for Retinopathy of Prematurity

Jaeb Center for Health ResearchLead Sponsor

153 Previous Clinical Trials

34,834 Total Patients Enrolled

2 Trials studying Retinopathy of Prematurity

136 Patients Enrolled for Retinopathy of Prematurity

Pediatric Eye Disease Investigator GroupNETWORK

18 Previous Clinical Trials

4,422 Total Patients Enrolled

2 Trials studying Retinopathy of Prematurity

136 Patients Enrolled for Retinopathy of Prematurity

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04634578 — Phase 2

Retinopathy of Prematurity Research Study Groups: Bevacizumab- 0.063 mg, Bevacizumab- 0.25 mg

Retinopathy of Prematurity Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT04634578 — Phase 2

Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634578 — Phase 2

Frequently Asked Questions

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

Can new patients still enroll in this research project?

"Yes, the information on clinicaltrials.gov points out that this study is presently recruiting patients. The clinical trial was initially posted on 5/18/2022 and was last edited on 10/18/2022. The study is admitting 80 patients across 36 sites in order to further test the efficacy of the proposed intervention."

Answered by AI

What has been the most common side effect in people who have taken Bevacizumab?

"While there is some evidence to support Bevacizumab's safety, it only received a score of 2 because this is still considered an early-stage medication with no Phase 3 data."

Answered by AI

How many participants will this clinical trial have in total?

"In order to move forward, this clinical study requires 80 volunteers that fit the pre-determined inclusion criteria. greater Baltimore Medical Center in Maryland and University of Chicago in Illinois are two sites where patients can take part in the trial."

Answered by AI

Are there many places in Canada where this clinical trial is taking place?

"This particular trial is being conducted in 36 hospitals, with a few notable locations including the Greater Baltimore Medical Center in Maryland, United States of America and the University of Missouri- Columbia Mason Eye Institute in Missouri."

Answered by AI

Could you provide a brief overview of other research projects that have included Bevacizumab?

"There are a total of 375 clinical trials investigating bevacizumab. Of these, 99 are in Phase 3. Most of the research is being conducted in Taibei, Taiwan; however, there are 18908 locations worldwide where studies related to this treatment are taking place."

Answered by AI

What is the medicine Bevacizumab used to heal?

"Bevacizumab is frequently used to treat cancer. Additionally, it can be helpful for patients with recurrent platinum sensitive primary peritoneal cancer, stage iv epithelial ovarian cancer who have undergone initial surgery, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bevacizumab Treatment For Type 1 ROP

2022. "Bevacizumab Treatment For Type 1 ROP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04634578.

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