High-Dose Aflibercept for Macular Edema
(QUASAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a higher dose of the eye injection aflibercept is more effective for treating macular edema caused by retinal vein occlusion (RVO). In individuals with RVO, a blocked vein in the eye causes swelling and blurry vision. Participants will receive either a higher dose of aflibercept or the standard dose, and researchers will compare their vision improvement. Suitable candidates for this trial have recently been diagnosed with macular edema due to RVO and have not received prior treatment for this condition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to advancing treatment options.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that aflibercept, a common treatment for macular edema from retinal vein issues, is generally safe and well-tolerated. Studies have found that even at higher doses, such as 8 mg, aflibercept does not significantly increase the risk of serious side effects. For instance, one study found that patients receiving the higher dose did not experience more adverse events than those on the standard dose.
Common side effects include eye pain or redness at the injection site, while serious side effects remain rare. Since aflibercept is already approved for other conditions, its safety profile is well-established. This trial examines whether a higher dose can be administered less frequently without additional risks, potentially making treatment more convenient.12345Why are researchers excited about this study treatment for macular edema?
Researchers are excited about using a higher dose of aflibercept for treating macular edema because it could potentially offer better control of the condition compared to the standard 2 mg dose. This treatment still works by blocking VEGF, a protein that contributes to the leakage and swelling in the retina, but the higher dosage might enhance its effectiveness. Additionally, the new regimen includes flexible dosing intervals tailored to the patient's response, which could mean fewer injections over time while maintaining or even improving vision outcomes.
What is the effectiveness track record for aflibercept in treating macular edema secondary to RVO?
Research shows that high-dose aflibercept, administered as an injection into the eye, can improve vision for individuals with certain eye conditions. In this trial, participants will receive either a higher dose of aflibercept or the standard 2 mg dose. Studies have demonstrated that an 8 mg dose of aflibercept results in better vision and eye health compared to the usual 2 mg dose. This higher dose might also reduce the number of injections needed, offering greater convenience for patients. Aflibercept works by blocking a protein that causes eye swelling, thereby reducing blurry vision. These findings suggest that a higher dose could be more effective for treating macular edema related to blocked veins in the retina.23678
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravitreal injections of aflibercept every 4 weeks for up to 60 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
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
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