What is the mechanism of action of this treatment?

The most common treatments for Macular Edema, particularly those involving VEGF inhibitors like Intravitreal Aflibercept, work by blocking the activity of vascular endothelial growth factor (VEGF). VEGF is a protein that promotes the growth of new blood vessels and increases vascular permeability, leading to fluid leakage and swelling in the retina. By inhibiting VEGF, these treatments reduce the abnormal blood vessel growth and fluid accumulation, thereby decreasing macular swelling and improving vision. This mechanism is crucial for patients with Macular Edema as it directly addresses the underlying cause of their vision impairment, offering a potential for significant visual improvement and stabilization.

What side effects are associated with this type of intervention?

The most common treatments for macular edema, particularly those involving VEGF inhibitors like intravitreal aflibercept, are generally well-tolerated but can have side effects. These include ocular discomfort, increased intraocular pressure, and potential for intraocular inflammation. Rare but serious adverse events can include retinal detachment, endophthalmitis (severe eye infection), and cataracts. Systemic side effects are uncommon but may include hypertension and thromboembolic events. Regular monitoring by an ophthalmologist is essential to manage and mitigate these risks.

What prior FDA approvals exist?

Intravitreal aflibercept, an FDA-approved treatment for macular edema secondary to retinal vein occlusion (RVO), works by inhibiting vascular endothelial growth factor (VEGF). Similar FDA-approved treatments include ranibizumab and bevacizumab, which also target VEGF to reduce macular edema. These drugs help by preventing the growth of abnormal blood vessels and reducing fluid leakage in the retina, thereby improving vision.

What other types of research exist?

Promising novel alternatives to Intravitreal Aflibercept for Macular Edema patients in 2024 include other VEGF inhibitors like Brolucizumab and Faricimab, which may offer different dosing schedules or efficacy profiles. Additionally, corticosteroid implants such as Dexamethasone intravitreal implant (Ozurdex) and Fluocinolone acetonide intravitreal implant (Iluvien) are viable options. Emerging therapies, including gene therapy and novel delivery systems, are also being explored in clinical trials and may provide future alternatives.

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VEGF Inhibitor

High-Dose Aflibercept for Macular Edema (QUASAR Trial)

Phase 3

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult ≥18 years of age (or country's legal age of adulthood if the legal age is >18 years) at the time of signing the informed consent

Decrease in BCVA determined to be primarily the result of RVO in the study eye

Must not have

Presence or history of corneal transplant or corneal dystrophy in the study eye

Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for RVO in the study eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 36 and week 64

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include general discomfort at injection site, increased risk of eye infection or inflammation, blurred vision or other changes in eyesight. Serious adverse events could lead to hospitalization or significant health issues but will be monitored throughout.

Eligibility Criteria

Inclusion Criteria

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

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I am an adult and legally able to give consent.

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My vision loss is mainly due to retinal vein occlusion in one eye.

Exclusion Criteria

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

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

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

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I am on dialysis or have had a kidney transplant.

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I have or had diabetic eye disease in both eyes.

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My other eye has received gene or cell therapy before.

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I have taken medication before to stop the formation of new blood vessels.

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I have had issues like blood in the eye or retinal detachment.

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I have or had an eye inflammation not caused by an infection.

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My eye was very nearsighted (-8 or more) before any eye surgery.

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I haven't had eye inflammation or infection in the last 12 weeks.

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I have or had advanced age-related vision loss in one eye.

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I do not have any eye infections or inflammation.

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I have an eye condition that could worsen my vision or need treatment during the study.

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I haven't had a stroke or heart attack in the last 24 weeks.

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I have or had a significant macular hole in my study eye.

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I have eye conditions like cataracts that affect my vision and imaging tests.

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I have glaucoma with an eye pressure over 25 mmHg, despite medication, or might need surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 36 and week 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 36 and week 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 36 and week 64 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 36

Secondary study objectives

Change from baseline in BCVA measured by the ETDRS letter score at Week 44

Change from baseline in BCVA measured by the ETDRS letter score at Week 64

Change from baseline in CST at Weeks 36 and 64

+2 more

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Higher Dose Regimen 2Experimental Treatment3 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 1Experimental Treatment3 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 careActive Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorescein

2015

Completed Phase 2

~300

Sham

2013

Completed Phase 3

~2090

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Macular Edema, particularly those involving VEGF inhibitors like Intravitreal Aflibercept, work by blocking the activity of vascular endothelial growth factor (VEGF). VEGF is a protein that promotes the growth of new blood vessels and increases vascular permeability, leading to fluid leakage and swelling in the retina. By inhibiting VEGF, these treatments reduce the abnormal blood vessel growth and fluid accumulation, thereby decreasing macular swelling and improving vision. This mechanism is crucial for patients with Macular Edema as it directly addresses the underlying cause of their vision impairment, offering a potential for significant visual improvement and stabilization.