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

Recruiting in Palo Alto (17 mi)

+334 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bayer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies

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

At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92)

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Exclusion Criteria

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

I have tears in the retina of my study eye.

Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg)

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Treatment Details

Interventions

Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) (VEGF Inhibitor)
Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) (VEGF Inhibitor)

Trial OverviewResearchers 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.

Participant Groups

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)