High-Dose Aflibercept for Macular Edema

(QUASAR Trial)

Recruiting at339 trial 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?

This trial is testing a higher dose of an eye injection called aflibercept in people with vision problems due to retinal vein occlusion. The goal is to see if a higher dose can be given less frequently while still helping to improve vision. The treatment works by blocking a protein that causes swelling in the eye. Researchers will compare vision improvements and safety between different doses. Aflibercept has been used to treat macular edema secondary to retinal vein occlusion and has shown efficacy in various studies.

Research Team

Eligibility Criteria

This trial is for adults over 18 with macular edema due to a blocked retinal vein, diagnosed within the past 16 weeks. They must have specific vision acuity and central swelling thickness, be treatment-naive, and agree to use effective contraception. Exclusions include uncontrolled diabetes, recent stroke or heart attack, other eye diseases affecting vision, previous certain treatments or surgeries for RVO in the affected eye.

Inclusion Criteria

Your eye has a certain level of fluid buildup, as confirmed by special eye scans.

I can sign the consent form myself or have someone legally allowed to do it for me.

Your vision score is between 73 and 24 on a special eye test in the eye being studied.

Exclusion Criteria

My study eye has not been treated with specific drugs or undergone certain procedures.

I have had a corneal transplant or suffer from corneal dystrophy in one eye.

I have not had treatments or surgery for retinal vein occlusion in my affected eye.

Treatment Details

Interventions

• Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose (VEGF Inhibitor)

Trial Overview The study tests whether a higher dose (8 mg) of aflibercept injected into the eye is more effective and safer than the standard dose (2 mg) for treating macular edema caused by retinal vein occlusion. The main goal is to see if there's an improvement in visual acuity after 36 weeks compared to standard care.

Participant Groups

Group I: Higher Dose Regimen 2 Experimental Treatment 3 Interventions

Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.

Group II: Higher Dose Regimen 1 Experimental Treatment 3 Interventions

Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.

Group III: Standard of care Active Control 2 Interventions

Aflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School