NCT07496567RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)
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)
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 960 (estimated)
- First submitted
- 23 Mar 2026
- Start date
- 15 Apr 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- EyeBiotech Ltd.
- Diseases
- Macular degeneration
- NCT number
- NCT07496567
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 960
- From 15 Apr 2026 to the primary completion date, 31 Jul 2028
- 71 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (71)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia (Site 332) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Clinica Oftalmologica del Caribe (COFCA) Coordinator of this site? Confirm its status | Barranquilla | Colombia | Recruiting |
| Fundacion Oftalmologica Nacional Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
| Clinica Imbanaco S.A.S Coordinator of this site? Confirm its status | Cali | Colombia | Recruiting |
| Clinica de Oftalmologia Sandiego Coordinator of this site? Confirm its status | Medellín | Colombia | Recruiting |
| Klaudians Hospital - Ophthalmology department Coordinator of this site? Confirm its status | Mladá Boleslav | Czechia | Recruiting |
| VISUS, spol s.r.o. Coordinator of this site? Confirm its status | Náchod | Czechia | Recruiting |
| Astra Clinic.s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Axon Clinical, s.r.o. (Site 400) Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Hospital General de Catalunya Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Oftalvist Coordinator of this site? Confirm its status | Burjassot -(Valencia) | Spain | Recruiting |
| Hôpital Intercommunal de Créteil Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Centre d'Ophtalmologie Paradis-Monticelli Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Ophtalmologique Saint Exupéry Coordinator of this site? Confirm its status | Saint-Cyr-sur-Loire | France | Recruiting |
| Budapest Retina Associates Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Presidio Ospedaliero Universitario "Santa Maria della Misericordia" Clinica Oculistica - Padiglione 7 - Piano 3 Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Espaço Médico de Coimbra Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| AIBILI Azinhaga de Santa Comba Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Northeast Wisconsin Retina Associates Coordinator of this site? Confirm its status | Appleton | United States | Recruiting |
| Asheville Eye Associates, Retina Division (Site 077) Coordinator of this site? Confirm its status | Asheville | United States | Recruiting |
| Charleston Neuroscience Institute (Site 034) Coordinator of this site? Confirm its status | Beaufort | United States | Recruiting |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Pacific Northwest Retina Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Envision Ocular, LLC Coordinator of this site? Confirm its status | Bloomfield | United States | Recruiting |
| NC Retina Coordinator of this site? Confirm its status | Cary | United States | Recruiting |
| Retina Consultants of Southern Colorado Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Connecticut Eye Consultants, P.C. Coordinator of this site? Confirm its status | Danbury | United States | Recruiting |
| RSC Research, LLC Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Retina Consultants of Minnesota Coordinator of this site? Confirm its status | Edina | United States | Recruiting |
| The Retina Partners Coordinator of this site? Confirm its status | Encino | United States | Recruiting |
| Erie Retina Research Coordinator of this site? Confirm its status | Erie | United States | Recruiting |
| Palmetto Retina Center Coordinator of this site? Confirm its status | Florence | United States | Recruiting |
| Retina Group of Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| Texas Retina Associates Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Associated Retina Consultants - Gilbert Coordinator of this site? Confirm its status | Gilbert | United States | Recruiting |
| Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY Coordinator of this site? Confirm its status | Great Neck | United States | Recruiting |
| Mid Atlantic Retina Specialists Coordinator of this site? Confirm its status | Hagerstown | United States | Recruiting |
| Graystone Eye Coordinator of this site? Confirm its status | Hickory | United States | Recruiting |
| Southeastern Retina Associates Coordinator of this site? Confirm its status | Hixson | United States | Recruiting |
| Southeastern Retina Associates (Site 095) Coordinator of this site? Confirm its status | Johnson City | United States | Recruiting |
| Illinois Retina Associates Coordinator of this site? Confirm its status | Joliet | United States | Recruiting |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Katy | United States | Recruiting |
| Southeastern Retina Associates, P.C. Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Charleston Neuroscience Institute Coordinator of this site? Confirm its status | Ladson | United States | Recruiting |
| University Retina & Macula Associates, P.C. Coordinator of this site? Confirm its status | Lemont | United States | Recruiting |
| Retina Associates LLC Coordinator of this site? Confirm its status | Lenexa | United States | Recruiting |
| Butchertown Clinical Trials Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Retina Consultants, P.C Coordinator of this site? Confirm its status | Manchester | United States | Recruiting |
| Northern California Retina Vitreous Associates Medical Group INC. Coordinator of this site? Confirm its status | Mountain View | United States | Recruiting |
| Tennessee Retina Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Florida Retina Institute Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Maine Eye Center (Site 097) Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Retina Consultants of Southern Colorado Coordinator of this site? Confirm its status | Pueblo | United States | Recruiting |
| Vistar Eye Center (Site 129) Coordinator of this site? Confirm its status | Roanoke | United States | Recruiting |
| Retina Associates of Western NY, PC (Site 051) Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Austin Retina Associates Coordinator of this site? Confirm its status | Round Rock | United States | Recruiting |
| Retina Consultants, LLC Coordinator of this site? Confirm its status | Salem | United States | Recruiting |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Austin Retina Associates Coordinator of this site? Confirm its status | San Marcos | United States | Recruiting |
| Orange County Retina Medical Group Coordinator of this site? Confirm its status | Santa Ana | United States | Recruiting |
| Retina Group of Florida (Site 065) Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Schertz | United States | Recruiting |
| Retina Research Institute at New England Retina Consultants, PC Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Cascade Medical Research Institute, LLC Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| NC Retina Associates Coordinator of this site? Confirm its status | Wake Forest | United States | Recruiting |
| Retina Group of New England Coordinator of this site? Confirm its status | Waterford | United States | Recruiting |
| Palmetto Retina Center Coordinator of this site? Confirm its status | West Columbia | United States | Recruiting |
| Wolfe Eye Clinic Coordinator of this site? Confirm its status | West Des Moines | United States | Recruiting |
| Salt Lake Retina Coordinator of this site? Confirm its status | West Jordan | United States | Recruiting |
| Center for Retina and Macular Disease (Site 062) Coordinator of this site? Confirm its status | Winter Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.