What this study is
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.
What's being tested
- Tiespectus
Intervention · DRUG
- Aflibercept
Intervention · DRUG
Both interventions
Administered by intravitreal (IVT) injection
Study details
- Official title
- 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)
- Sponsor
- EyeBiotech Ltd.
- Conditions
- Macular Degeneration · Age-Related Macular Degeneration · Choroidal Neovascularization · Wet Macular Degeneration
- Enrolling
- 960 people
- Starts
- 2026-04-15
- Est. completion
- 2028-07-31
- Design
- Triple-blind, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (71)
71 openAssociated Retina Consultants - Gilbert
Gilbert, Arizona, United States
- Study Coordinator · Contact602-242-4928
RecruitingThe Retina Partners
Encino, California, United States
- Jesus Vargas · Contact818-788-9333 ext. 1141jesusv@theretinapartners.com
- Amir Guerami · Principal investigator
RecruitingNorthern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States
- Study Coordinator · Contact650-963-3465
RecruitingOrange County Retina Medical Group
Santa Ana, California, United States
- Study Coordinator · Contact714-972-8432
RecruitingRetina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
- Study Coordinator · Contact719-473-9595
Recruiting- Recruiting
Retina Consultants of Southern Colorado
Pueblo, Colorado, United States
- Study Coordinator · Contact719-473-9595
RecruitingConnecticut Eye Consultants, P.C.
Danbury, Connecticut, United States
- Study Coordinator · Contact203-791-2020
RecruitingRetina Consultants, P.C.
Manchester, Connecticut, United States
- Study Coordinator · Contact860-646-7704
RecruitingRetina Group of New England
Waterford, Connecticut, United States
- Study Coordinator · Contact860-444-1292
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- Recruiting
Retina Group of Florida (Site 065)
Sarasota, Florida, United States
- Study Coordinator · Contact941-924-0303
RecruitingCenter for Retina and Macular Disease (Site 062)
Winter Haven, Florida, United States
- Study Coordinator · Contact863-297-5400 ext. 2020
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University Retina & Macula Associates, P.C.
Lemont, Illinois, United States
- Study Coordinator · Contact708-765-4110
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- Recruiting
Butchertown Clinical Trials
Louisville, Kentucky, United States
- Study Coordinator · Contact502-589-1500
Recruiting- Recruiting
Mid Atlantic Retina Specialists
Hagerstown, Maryland, United States
- Study Coordinator · Contact301-671-2400
RecruitingRetina Research Institute at New England Retina Consultants, PC
Springfield, Massachusetts, United States
- Study Coordinator · Contact413-732-2333
RecruitingRetina Consultants of Minnesota
Edina, Minnesota, United States
- Study Coordinator · Contact952-259-6262
RecruitingEnvision Ocular, LLC
Bloomfield, New Jersey, United States
- Study Coordinator · Contact973-707-5632 ext. 1124
RecruitingLong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY
Great Neck, New York, United States
- Study Coordinator · Contact516-466-0390
RecruitingRetina Associates of Western NY, PC (Site 051)
Rochester, New York, United States
- Study Coordinator · Contact585-450-2082
RecruitingAsheville Eye Associates, Retina Division (Site 077)
Asheville, North Carolina, United States
- Study Coordinator · Contact828-255-8008 ext. 2824
RecruitingNC Retina
Cary, North Carolina, United States
- Amanda Smith · Contact919-782-8038asmith@ncretina.com
- Lekha Desai · Principal investigator
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NC Retina Associates
Wake Forest, North Carolina, United States
- Amanda Smith · Contact919-782-8038asmith@ncretina.com
- John Thordsen · Principal investigator
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Cascade Medical Research Institute, LLC
Springfield, Oregon, United States
- Study Coordinator · Contact541-687-1927
Recruiting- Recruiting
Charleston Neuroscience Institute (Site 034)
Beaufort, South Carolina, United States
- Study Coordinator · Contact843-763-4466 ext. 1404
RecruitingPalmetto Retina Center
Florence, South Carolina, United States
- Study Coordinator · Contact803-931-0077
RecruitingCharleston Neuroscience Institute
Ladson, South Carolina, United States
- Study Coordinator · Contact843-763-4466
RecruitingPalmetto Retina Center
West Columbia, South Carolina, United States
- Study Coordinator · Contact803-744-0158
RecruitingSoutheastern Retina Associates
Hixson, Tennessee, United States
- KaSandra "Kassy" Schratter · Contact423-756-1002kschratter@seretina.com
- Devon Ghodasra · Principal investigator
RecruitingSoutheastern Retina Associates (Site 095)
Johnson City, Tennessee, United States
- Study Coordinator · Contact423-578-4364
RecruitingSoutheastern Retina Associates, P.C.
Knoxville, Tennessee, United States
- Study Coordinator · Contact865-588-0811
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- Recruiting
Texas Retina Associates
Fort Worth, Texas, United States
- Study Coordinator · Contact817-334-0882 ext. 405
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- Recruiting
Retina Consultants of Texas
San Antonio, Texas, United States
- Study Coordinator · Contact210-903-1046 ext. 2051
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- Recruiting
- Recruiting
- Recruiting
Northeast Wisconsin Retina Associates
Appleton, Wisconsin, United States
- Study Coordinator · Contact920-751-8666
Recruiting
19 sites outside the US
IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia (Site 332)
São Paulo, Brazil
- Study Coordinator · Contact5511 3016-4096
RecruitingClinica Oftalmologica del Caribe (COFCA)
Barranquilla, Colombia
- Study Coordinator · Contact57 3043909153
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Klaudians Hospital - Ophthalmology department
Mladá Boleslav, Czechia
- Study Coordinator · Contact420731542840
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- Recruiting
- Recruiting
- Recruiting
Centre d'Ophtalmologie Paradis-Monticelli
Marseille, France
- Study Coordinator · Contact+33 4 91 16 05 84
RecruitingCentre Ophtalmologique Saint Exupéry
Saint-Cyr-sur-Loire, France
- Study Coordinator · Contact(+33) 6 2633 1609
Recruiting- Recruiting
Presidio Ospedaliero Universitario "Santa Maria della Misericordia" Clinica Oculistica - Padiglione 7 - Piano 3
Udine, Italy
- Study Coordinator · Contact(+39) 0432 559905
Recruiting- Recruiting
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Study team
Sponsor
EyeBiotech Ltd.
Study ID 8748-003
Study director
Medical Director
Merck Sharp & Dohme LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.