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Monoclonal Antibodies

Anti-VEGF Therapy for Retinal Vein Occlusion

Phase 4
Waitlist Available
Led By Mark Nelson, MD
Research Sponsored by Wake Forest University Health Sciences
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 baseline through week 52
Awards & highlights

Study Summary

This trial will test whether anti-vascular endothelial growth factor therapy can improve vision in patients with retinal vein occlusion and whether measuring the level of vascular endothelial growth factor can help predict when treatment will be needed.

Who is the study for?
This trial is for individuals with Retinal Vein Occlusion (RVO) who have macular edema and a central foveal thickness of at least 300 microns. Participants must have visual acuity between 20/25 and 5/200, be willing to consent, and not be pregnant or breastfeeding. Exclusions include recent severe cardiovascular events, other eye diseases like Diabetic Retinopathy or Maculopathy, previous eye surgeries in the affected eye, allergies to study treatments or related ingredients.Check my eligibility
What is being tested?
The trial tests Aflibercept Ophthalmic treatment on patients with RVO to see if measuring Vascular Endothelial Growth Factor (VEGF) levels can predict when this anti-VEGF therapy is needed. The goal is to correlate VEGF levels in the eye's fluid with the timing of treatment necessity.See study design
What are the potential side effects?
Potential side effects may include irritation at the injection site within the eye, increased intraocular pressure, blurred vision temporarily after administration, possible allergic reactions if sensitive to Aflibercept components.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Macular retinal edema
Change in Macular Volume
Change in Vascular Endothelial Growth Factor (VEGF) level in Anterior Chamber
Secondary outcome measures
Change in Analytes - Chemokine (C-C motif) ligand (CCL)s
Change in Analytes - Growth factors
Change in Analytes - Interferons
+6 more

Side effects data

From 2020 Phase 4 trial • 26 Patients • NCT03022292
4%
Retinal detachment
4%
Myelodysplastic syndrome
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IAI Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: AfliberceptExperimental Treatment1 Intervention
All subjects will receive aflibercept every 4 weeks. Once vascular endothelial growth factor levels become normal and macular edema improves treatment windows will be extended up to every 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept Ophthalmic
2017
Completed Phase 4
~30

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,220 Total Patients Enrolled
Mark Nelson, MDPrincipal InvestigatorWake Forest Baptist Medical Center
5 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Aflibercept Ophthalmic (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04707625 — Phase 4
Retinal Vein Occlusion Research Study Groups: Aflibercept
Retinal Vein Occlusion Clinical Trial 2023: Aflibercept Ophthalmic Highlights & Side Effects. Trial Name: NCT04707625 — Phase 4
Aflibercept Ophthalmic (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04707625 — Phase 4

Frequently Asked Questions

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

What objectives are being pursued by this clinical investigation?

"The primary purpose of this trial, evaluated over a period extending from the baseline to 52 weeks, is to measure changes in Vascular Endothelial Growth Factor (VEGF) levels in anterior chambers. Secondary objectives include monitoring any alterations in Best Corrected Visual Acuity (BCVA), analysing chemokine CXCL1/GRO alpha/KC/Cytokine-induced neutrophil chemoattractant (CINC-1) and CXCL2/GRO beta/MIPs /CINC3 by an ELISA multiplex, as well as tracking the number of intravitreal"

Answered by AI

Is this research endeavor still accepting new participants?

"Affirmative. Evident from the information on clinicaltrials.gov, this medical experiment is actively recruiting participants whose profiles match its criteria. This trial was first published on October 6th 2021 and most recently updated on January 5th 2022; it requires 10 patients to be recruited at a single site."

Answered by AI

What diseases or ailments does this therapy typically target?

"This medication is typically prescribed for wet age-related macular degeneration (wAMD); nevertheless, it can also benefit patients with other conditions such as diabetic macular edema (DME) and generalised retinal swelling."

Answered by AI

What security measures are in place to ensure the safety of those receiving this treatment?

"The safety of this particular intervention is highly regarded, and as such it scored a 3 on our rating system. This reflects the fact that it is approved for use in Phase 4 trials."

Answered by AI

How many subjects are included in the ongoing clinical trial?

"Affirmative. The info available on clinicaltrials.gov suggests that this medical experiment is actively looking for applicants as of now. This study was initially posted on October 6th 2021, and has since been modified most recently on January 5th 2022. 10 candidates are being sought from a single site in total."

Answered by AI
Recent research and studies
~5 spots leftby Apr 2025