Actively Recruiting
A Randomized, Double-Masked, Multicenter Study Comparing the Safety and Effectiveness of Intravitreal EYE201/MK-8748 (Tiespectus) to Aflibercept in People with Neovascular Age-Related Macular Degeneration
Led by EyeBiotech Ltd. · Updated on 2026-05-04
960
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new treatments for neovascular age-related macular degeneration (NVAMD), a form of wet macular degeneration. This study aims to find out if a medicine called tiespectus (also known as MK-8748 or EYE201) can treat NVAMD as effectively as the current standard treatment, aflibercept. The trial is a pivotal Phase 2/3 study comparing these treatments in people with this eye condition. Participants will be randomly assigned to one of three groups: one receiving a low dose of tiespectus, another receiving a high dose of tiespectus, and a third group receiving aflibercept. The tiespectus groups start with three injections every four weeks, then continue with injections every eight weeks until week 48. After this, the treatment schedule is personalized up to week 92. The aflibercept group also receives three initial injections followed by injections every eight weeks until week 92. During the study, participants will have their vision assessed using best-corrected visual acuity (BCVA) and other eye measurements at baseline and through one year. Researchers will monitor changes in vision, eye thickness, and any side effects. The entire study period includes treatment and follow-up visits up to approximately 92 weeks, allowing detailed observation of treatment effects and safety over time.
CONDITIONS
Brief Title
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 years or older
- Have treatment-naive choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) in at least one eye
- Diagnosis of neovascular age-related macular degeneration made within 21 days before starting study treatment
You will not qualify if you...
- Uncontrolled blood pressure at screening
- History of prior macular laser photocoagulation in the study eye
- History of uveitis in either eye
- Cataract surgery, minimally invasive glaucoma surgery, or YAG laser capsulotomy in the study eye within 90 days before entering the study
- Uncontrolled glaucoma in the study eye
- Active retinal disease other than the study condition in the study eye
- Prior anti-VEGF or other intravitreal therapy in the study eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 92 weeks
Participants receive intravitreal injections of either Tiespectus (low or high dose) or Aflibercept to treat neovascular age-related macular degeneration.
3 initial injections every 4 weeks, then injections every 8 weeks until week 48, followed by treatment intervals based on individual response up to week 92
Trial Site Locations
Total: 9 locations
1
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States, 94040
Actively Recruiting
2
University Retina & Macula Associates, P.C.
Lemont, Illinois, United States, 60439
Actively Recruiting
3
Mid Atlantic Retina Specialists
Hagerstown, Maryland, United States, 21740
Actively Recruiting
4
Retina Consultants of Minnesota
Edina, Minnesota, United States, 55435
Actively Recruiting
5
Envision Ocular, LLC
Bloomfield, New Jersey, United States, 07003
Actively Recruiting
6
Erie Retina Research
Erie, Pennsylvania, United States, 16505
Actively Recruiting
7
Charleston Neuroscience Institute
Ladson, South Carolina, United States, 29456
Actively Recruiting
8
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
Actively Recruiting
9
Pacific Northwest Retina
Bellevue, Washington, United States, 98004
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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