High-Dose Aflibercept for Macular Edema

(QUASAR Trial)

Recruiting at 344 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bayer

Must not be taking: Anti-angiogenic, Steroids

Disqualifiers: Advanced AMD, Diabetic retinopathy, Uncontrolled glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 18

Duration: 60 weeks

892 Participants Needed

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does exclude participants who have had certain treatments for the study eye, like anti-VEGF drugs or steroids, within specific time frames before the trial.

What data supports the effectiveness of the drug Aflibercept for treating macular edema?

Aflibercept has been shown to improve vision in patients with various types of macular edema, such as those caused by diabetic conditions and retinal vein occlusions, by blocking factors that lead to abnormal blood vessel growth in the eye. Clinical trials have demonstrated significant improvements in visual acuity and retinal thickness compared to other treatments, indicating its effectiveness. ^{1 2 3 4 5}

Is high-dose aflibercept safe for humans?

Aflibercept, also known as Eylea, has been generally well tolerated in studies for various eye conditions, with a safety profile consistent with its known effects. It has been tested in conditions like diabetic macular edema and macular edema due to vein occlusion, showing it is generally safe for use in humans. ^{1 3 5 6 7}

How does the drug Aflibercept differ from other treatments for macular edema?

Aflibercept is unique because it acts as a decoy receptor that binds to and blocks proteins like VEGF-A and placental growth factor, which are involved in abnormal blood vessel growth and leakage in the eye. This drug is administered through an injection into the eye and has shown significant improvements in vision compared to other treatments like laser therapy. ^{1 2 3 4 5}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive intravitreal injections of aflibercept every 4 weeks for up to 60 weeks

60 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

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

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

Findings from Research

Aflibercept is a newly approved anti-VEGF drug that effectively suppresses choroidal neovascularization in patients with exudative age-related macular degeneration, showing excellent short-term results in clinical trials.

In pivotal phase 3 trials, aflibercept demonstrated comparable efficacy and safety to ranibizumab while requiring fewer injections, potentially leading to lower overall treatment costs for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept for age-related macular degeneration: a game-changer or quiet addition? Browning, DJ., Kaiser, PK., Rosenfeld, PJ., et al.[2013]

In a study involving 40 patients with diabetic macular edema (DME), a treat-and-extend regimen using aflibercept showed significant improvement in central subfield macular thickness (CST) but limited gains in best-corrected visual acuity (BCVA) after one year.

The study found that patients who responded well to initial treatments (gaining 4 or more letters in vision) experienced greater overall vision improvement, suggesting that early response to treatment may predict better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treat-and-extend therapy with aflibercept for diabetic macular edema: a prospective clinical trial. Hirano, T., Toriyama, Y., Takamura, Y., et al.[2021]

Aflibercept, a recombinant fusion protein, effectively inhibits VEGF signaling and has been shown to significantly improve visual acuity in patients with macular edema due to central retinal vein occlusion (CRVO) when administered intravitreally at a dose of 2 mg monthly, as demonstrated in clinical trials with significant improvements over sham injections.

The treatment was generally well tolerated with minimal risk of systemic drug accumulation, making aflibercept a safe and effective option for managing CRVO-related macular edema, although optimal monitoring strategies for long-term efficacy still need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal aflibercept (Eylea(®)): a review of its use in patients with macular oedema secondary to central retinal vein occlusion. Yang, LP., McKeage, K.[2021]

Intravitreal aflibercept significantly improved visual acuity in patients with diabetic macular oedema compared to macular laser photocoagulation and other treatments like bevacizumab and ranibizumab, particularly in those with worse baseline vision, as shown in phase III trials.

Aflibercept was generally well tolerated, making it a promising and effective new treatment option for diabetic macular oedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept: A Review of Its Use in Diabetic Macular Oedema. Keating, GM.[2022]

In a study involving 24 rabbits with chemically induced corneal neovascularization, treatments with aflibercept, betamethasone, or their combination did not significantly reduce neovascularization compared to a control group.

Despite the lack of efficacy in reducing neovascularization, all treatment groups showed lower VEGF levels than the control, suggesting that while these treatments may affect VEGF concentration, they do not effectively reverse the neovascularization process in this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Subconjunctival Aflibercept and Betamethasone for the Treatment of Formed Corneal Neovascularization in a Rabbit Model. Eiger-Moscovich, M., Livny, E., Sella, R., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Aflibercept for age-related macular degeneration: a game-changer or quiet addition? [2013]

2. Japan pubmed.ncbi.nlm.nih.gov

Treat-and-extend therapy with aflibercept for diabetic macular edema: a prospective clinical trial. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Aflibercept: A Review in Macular Oedema Secondary to Branch Retinal Vein Occlusion. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Intravitreal aflibercept (Eylea(®)): a review of its use in patients with macular oedema secondary to central retinal vein occlusion. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Aflibercept: A Review of Its Use in Diabetic Macular Oedema. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Subconjunctival Aflibercept and Betamethasone for the Treatment of Formed Corneal Neovascularization in a Rabbit Model. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Phase 1 study of aflibercept administered subcutaneously to patients with advanced solid tumors. [2022]