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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

Must not have

Scar, fibrosis, or atrophy involving the central subfield in the study eye

Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and week 60

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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My vision loss is mainly due to wet AMD in one eye.

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I have wet AMD affecting the center of my vision in the study eye.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have scarring or tissue loss in the central part of my eye.

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I have tears in the retina of my study eye.

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My eye condition is not due to nAMD.

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I do not have any eye infections or inflammation.

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I have had uveitis in my eye without a known cause.

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I have not had treatments or surgery for nAMD in the affected eye, except for vitamins.

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I have had eye problems related to diabetes or other blood vessel issues in the eye.

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My eye pressure is high (>25 mmHg) despite using glaucoma medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and week 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and week 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and week 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48

Secondary study objectives

Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60

Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48

Side effects data

From 2024 Phase 3 trial • 1011 Patients • NCT04423718

Visual acuity reduced

Visual acuity reduced in study eye

COVID-19

Neovascular age-related macular degeneration

Retinal haemorrhage

Nasopharyngitis

Back pain

Hypertension

Cerebrovascular accident

Urinary tract infection

Hyponatraemia

Pelvic fracture

Cerebral infarction

Rib fracture

Bladder neoplasm

Upper limb fracture

100%

80%

60%

40%

20%

Study treatment Arm

Aflibercept 2q8

Aflibercept HDq12

Aflibercept HDq16

All Aflibercept HD

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)

2020

Completed Phase 3

~1020

0 / 10Eligibility criteria met