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VEGF Inhibitor

High-Dose Aflibercept for Age-Related Macular Degeneration (PULSAR Trial)

Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Decrease in BCVA determined to be primarily the result of nAMD in the study eye
Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 156 weeks
Awards & highlights

PULSAR Trial Summary

This trial will study the effects of a high dose of Aflibercept on visual acuity in patients with neovascular age-related macular degeneration.

Who is the study for?
This trial is for adults with neovascular age-related macular degeneration (nAMD), which causes vision issues due to leaking blood vessels in the eye. Participants should have certain levels of visual acuity and a specific area of abnormal blood vessel growth. They must use effective contraception and not have other eye diseases, uncontrolled glaucoma, severe myopia, or untreated high blood pressure.Check my eligibility
What is being tested?
Researchers are testing a high dose of Aflibercept (Eylea) injected into the eye to see if it improves vision clarity in patients with nAMD. The study compares this higher dose's effectiveness against the standard treatment to determine its impact on vision distortion caused by fluid buildup in the retina.See study design
What are the potential side effects?
Potential side effects from Aflibercept injections include redness or pain at the injection site, increased intraocular pressure, cataract formation, retinal detachment, vitreous floaters, inflammation inside the eye and possible infection.

PULSAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My vision loss is mainly due to wet AMD in one eye.
Select...
I have wet AMD affecting the center of my vision in the study eye.

PULSAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 156 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 156 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
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48
Secondary outcome measures
Assessment of Immunogenicity to Aflibercept by Measuring the Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response Through End of Masked Study
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60
Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48
+9 more

PULSAR Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Aflibercept HDq16Experimental Treatment1 Intervention
Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
Group II: Aflibercept HDq12Experimental Treatment1 Intervention
Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
Group III: Aflibercept 2q8Active Control2 Interventions
In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental)

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
378,836 Total Patients Enrolled
BayerLead Sponsor
2,237 Previous Clinical Trials
25,325,967 Total Patients Enrolled

Media Library

Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) (VEGF Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04423718 — Phase 3
Age-Related Macular Degeneration Research Study Groups: Aflibercept 2q8, Aflibercept HDq12, Aflibercept HDq16
Age-Related Macular Degeneration Clinical Trial 2023: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) Highlights & Side Effects. Trial Name: NCT04423718 — Phase 3
Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) (VEGF Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04423718 — Phase 3
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT04423718 — Phase 3

Frequently Asked Questions

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

Is this clinical trial offered in different hospitals throughout the state?

"There are 70 total clinical trial sites for this study, which are enrolling patients presently. Some notable locations include Valley Retina Institute in Los Angeles, California, Jules Stein Eye Institute, UCLA in Winnipeg, Manitoba, and Misericordia Health Centre in Shawnee Mission, Kansas."

Answered by AI

Does this research project need more participants?

"According to the latest information found on clinicaltrials.gov, this particular clinical trial is no longer actively recruiting patients. The trial was first posted on 8/11/2020, and was last edited on 10/12/2022. However, there are 218 other studies that are still enrolling patients."

Answered by AI

Has BAY86-5321 received FDA approval for aflibercept high dose VEGF trap-eye?

"Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) has been deemed safe by our team at Power. It receives a 3 on our 1-3 scale because it is a Phase 3 trial, signifying that there is both efficacy data and multiple rounds of safety data supporting its use."

Answered by AI

Are there any other clinical trials that have used Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)?

"Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) was first trialed in 2014 at M D Anderson Cancer Center. Since then, 227 similar clinical trials have been completed. At the moment, 49 live clinical trials are being conducted, a majority of which are based in Los Angeles, California."

Answered by AI

How many people will be given the chance to participate in this research?

"This trial is no longer taking in patients. The original posting date was 8/11/2020, with the last update on 10/12/2022. However, if the patient is looking for other trials, there are 169 for macular degeneration and 49 for Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) that are still open."

Answered by AI

For what condition is Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) most often prescribed?

"Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) is an effective treatment for three separate conditions: wet age-related macular degeneration (wamd), macular edema, and diabetic macular edema (dme)."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Texas
Other
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Arizona Retina and Vitreous Consultants - Research
Jules Stein Eye Institute, UCLA
Retina Macula Specialists of Miami
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
0

Why did patients apply to this trial?

I had an eye exam and was told I have beginnings of macular disease. My mother and aunt both loss their eyesight. I am hoping to help myself and others avoid blindness.
PatientReceived 1 prior treatment
I have been diagnosed with amd but still have good vision (with corrective lenses). Not sure whether I qualify for any studies.
PatientReceived no prior treatments
I wish to do all hat is possible to freeze my eye condition close to where it is or maybe even improve it/ I understand there is a Jacksonville FL location but it did not com up on the list of options.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
2020. "Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04423718.
All > Vision > Wet Macular Degeneration
~217 spots leftby Apr 2025
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