Tiespectus (MK-8748) versus aflibercept to treat neovascular (wet) age-related macular degeneration
A Randomized Double-masked, Multicenter, 3-arm, Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) EYE201/MK-8748 Compared to Aflibercept (2 mg) in Participants With Neovascular Age-related Macular Degeneration (NVAMD)
The study will see if tiespectus (MK-8748) works as well as aflibercept for people with newly diagnosed neovascular (wet) age-related macular degeneration.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 960 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | EyeBiotech Ltd. Industry-sponsored |
| Locations | 9 sites (Mountain View, California and 8 other locations) |
| Trial ID | NCT07496567 on ClinicalTrials.gov |
What this trial studies
This Phase 2/3 interventional trial compares the investigational agent tiespectus (MK-8748) with the approved anti-VEGF drug aflibercept in people with treatment-naive neovascular AMD. Eligible participants must have a new diagnosis of choroidal neovascularization related to AMD made within 21 days and will receive intravitreal injections of one of the two treatments with scheduled follow-up visits to monitor vision and retinal status. Key exclusion criteria include uncontrolled blood pressure, uncontrolled glaucoma, recent intraocular surgery, history of uveitis, prior macular laser in the study eye, or other active retinal disease. The trial is being run at multiple retina centers in the United States to collect safety and effectiveness data across sites.
Who should consider this trial
Good fit: Adults with treatment-naive choroidal neovascularization secondary to AMD diagnosed within 21 days, affecting at least one eye, who meet ocular health requirements and have controlled systemic conditions are the intended candidates.
Not a fit: People with prior treatment for CNV, uncontrolled blood pressure or glaucoma, recent intraocular surgery, history of uveitis, or other active retinal diseases are unlikely to qualify and may not benefit.
Why it matters
Potential benefit: If tiespectus works as hoped, it could provide an additional injectable treatment option comparable to aflibercept for people with newly diagnosed wet AMD.
How similar studies have performed: Approved anti-VEGF drugs such as aflibercept and ranibizumab have established effectiveness for NVAMD, while tiespectus (MK-8748) is a newer agent with limited published clinical results to date.
Eligibility criteria
Show full inclusion / exclusion criteria
The main inclusion criteria include but are not limited to the following: * Has treatment naive choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferations (RAP) and polypoidal choroidal vascularization (PCV) lesions in at least one eye (study eye) * The diagnosis of neovascular age-related macular degeneration (NVAMD) must have been made within 21 days prior to starting study treatment The main exclusion criteria include but are not limited to the following * Has uncontrolled blood pressure at screening * History of any prior macular laser photocoagulation in the study eye * History of uveitis in either eye * History of cataract surgery, minimally invasive glaucoma surgery, or Yttrium-Aluminium Garnet (Yag) laser capsulotomy in the study eye within 90 days before entering the study * Has uncontrolled glaucoma in the study eye * Active retinal disease other than the condition under investigation in the study eye * Has previously received anti- vascular endothelial growth factor (VEGF) therapy or other intravitreal (IVT) therapy in the study eye
Where this trial is running
Mountain View, California and 8 other locations
- Northern California Retina Vitreous Associates Medical Group, Inc. — Mountain View, California, United States (Recruiting)
- University Retina & Macula Associates, P.C. — Lemont, Illinois, United States (Recruiting)
- Mid Atlantic Retina Specialists — Hagerstown, Maryland, United States (Recruiting)
- Retina Consultants of Minnesota — Edina, Minnesota, United States (Recruiting)
- Envision Ocular, LLC — Bloomfield, New Jersey, United States (Recruiting)
- Erie Retina Research — Erie, Pennsylvania, United States (Recruiting)
- Charleston Neuroscience Institute — Ladson, South Carolina, United States (Recruiting)
- Retina Consultants of Texas — Bellaire, Texas, United States (Recruiting)
- Pacific Northwest Retina — Bellevue, Washington, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.