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Monoclonal Antibodies
Intravitreal Aflibercept Injection for Proliferative Vitreoretinopathy (PREVENT-PVR Trial)
Phase 2
Recruiting
Led By Mohammed A Khan, M
Research Sponsored by M. Ali Khan, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
PREVENT-PVR Trial Summary
This trial is testing if a medication can help improve the success rate of surgery for people with a certain eye condition.
Who is the study for?
This trial is for adults with a specific type of retinal detachment at high risk for PVR, who consent to certain surgical repairs and can follow the study schedule. It's not for those under 18, pregnant or breastfeeding women, recent users of anti-VEGF drugs, or individuals unwilling to use contraception.Check my eligibility
What is being tested?
The trial tests if multiple injections of Aflibercept into the eye can prevent PVR after retinal detachment surgery compared to a sham control. Participants are chosen randomly to receive either the real treatment or a placebo.See study design
What are the potential side effects?
Aflibercept may cause eye-related side effects such as increased intraocular pressure, cataract formation, and possible inflammation inside the eye. Systemic side effects are rare but could include headache and cold-like symptoms.
PREVENT-PVR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Single surgery anatomic success (retinal re-attachment) rate
Secondary outcome measures
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points
OCT-measured central subfield thickness
+2 morePREVENT-PVR Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention (serial IAI)Experimental Treatment1 Intervention
Intravitreal aflibercept injection (2mg/0.05mL) at the conclusion of RRD repair surgery, at post-operative day 30 (+/-7 days), and at post-operative day 60 (+/-7 days)
Group II: ControlPlacebo Group1 Intervention
Patients enrolled in the control group will undergo a sham procedure at post-operative day 30 (+/-7 days) and at post-operative day 60 (+/-7 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intravitreal aflibercept injection
2022
Completed Phase 4
~190
Find a Location
Who is running the clinical trial?
Southeastern Retina AssociatesUNKNOWN
Eye Associates of New MexicoUNKNOWN
University of California, Los AngelesOTHER
1,529 Previous Clinical Trials
10,277,701 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received medication directly into your eye or throughout your body to treat a condition related to blood vessels in the past 6 months.You have had or currently have certain eye conditions, such as a ruptured eye, foreign object in the eye, diabetic eye disease, blocked blood vessels in the eye, certain age-related eye disease, or specific eye infections.You have had eye surgery in the past, except for removing cataracts.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention (serial IAI)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the participant enrollment for this trial?
"Affirmative. Records hosted on clinicaltrials.gov supply evidence that this research project, first posted on October 15th 2020, is currently seeking participants. Approximately 150 people will be enrolled from a single trial site."
Answered by AI
What conditions typically respond to Intravitreal aflibercept injection?
"Intravitreal aflibercept injection is both an effective and safe treatment for wet age-related macular degeneration (wAMD). It has also been employed to alleviate associated conditions such as diabetic macular edema, retinal vein occlusion, and choroidal neovascularization."
Answered by AI
Is it possible to still join this research endeavor?
"According to the data on clinicaltrials.gov, this medical research is actively searching for participants. The trial was published in October 2020 and amended in May 2022."
Answered by AI
To what extent can intravitreal aflibercept injection pose a risk for patients?
"Our assessment of intravitreal aflibercept injection's safety is rated 2, indicating that while clinical evidence exists to back its security there are no studies attesting to its efficacy."
Answered by AI
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