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Bevacizumab for Retinopathy of Prematurity (ROP4 Trial)
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.
ROP4 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowROP4 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 45 Patients • NCT02036424ROP4 Trial Design
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Who is running the clinical trial?
Media Library
- I was recently diagnosed with a specific eye condition in the past 2 days.I have been treated for retinopathy of prematurity before.My birth weight was less than 1251 grams.My eye condition is at stage 4 or 5 ROP.My type 1 ROP was not treated within 2 days of diagnosis.I am not planning to transfer to a hospital that is not part of the study, and I can return for follow-up visits.I have a major eye problem, like cataract.My doctor or my child's doctor is not open to random treatment assignment.I do not have an eye infection or blocked tear duct with pus.
- Group 1: Bevacizumab- 0.063 mg
- Group 2: Bevacizumab- 0.25 mg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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