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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 36 and week 64
Awards & highlights

QUASAR Trial Summary

This trial is researching a higher dose of intravitreal aflibercept for patients with macular edema due to retinal vein occlusion, which could reduce the number of injections needed.

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.Check my eligibility
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.See study design
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.

QUASAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an adult and legally able to give consent.
Select...
My vision loss is mainly due to retinal vein occlusion in one eye.

QUASAR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in BCVA measured by the ETDRS letter score at Week 36
Secondary outcome measures
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
+11 more

QUASAR 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
Sham
2013
Completed Phase 3
~2060
Fluorescein
2015
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
622 Previous Clinical Trials
379,909 Total Patients Enrolled
33 Trials studying Macular Edema
11,574 Patients Enrolled for Macular Edema
BayerLead Sponsor
2,240 Previous Clinical Trials
25,331,955 Total Patients Enrolled
28 Trials studying Macular Edema
12,514 Patients Enrolled for Macular Edema

Media Library

Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose (VEGF Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05850520 — Phase 3
Macular Edema Research Study Groups: Higher Dose Regimen 1, Higher Dose Regimen 2, Standard of care
Macular Edema Clinical Trial 2023: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose Highlights & Side Effects. Trial Name: NCT05850520 — Phase 3
Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose (VEGF Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05850520 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is the implementation of this trial?

"Currently, 312 medical centres are participating in this research trial. These sites can be found in Loma Linda, Long Beach and Mountain View along with 309 other locations spread across the country. To minimize travel requirements, it is strongly recommended to select a site close by if you decide to enroll."

Answered by AI

Has the Higher Dose Regimen 1 been sanctioned by the FDA?

"Considering the robust evidence indicating efficacy and safety, our team at Power awarded Higher Dose Regimen 1 a rating of 3 out of 3. This reflects its Phase 3 trial status which confirms extensive research has been conducted into this treatment option."

Answered by AI

Is enrollment currently available for this trial?

"Information hosted on clinicaltrials.gov affirms that this research endeavor is not presently recruiting participants; it was initially posted on May 9th 2023 and last edited April 28th 2023. Notwithstanding, there are currently 788 other studies actively searching for patients to participate in their trials."

Answered by AI

Who else is applying?

What site did they apply to?
Florida Retina Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Just diagnosed with Diabetes Macular Edema.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)
2023. "A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05850520.
All > Macular Edema > Spokane
~320 spots leftby Nov 2024
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