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Macular DegenerationPhase 2/3TORRONTESNCT07496567

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)

A Phase 2/3 study testing Tiespectus and Aflibercept in people with Macular Degeneration and Age-Related Macular Degeneration, run by EyeBiotech Ltd. at 71 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Tiespectus and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
960 participants
Where
71 sitesin 9 countries
Study dates
15 Apr 2026to 31 Jul 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

71 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

71 sites in 9 countries

United States52 sites, 52 recruiting

  • Northeast Wisconsin Retina Associates

    Appleton, Wisconsin, 54914

    Study Coordinator, 920-751-8666

    Recruiting

  • Asheville Eye Associates, Retina Division (Site 077)

    Asheville, North Carolina, 28803

    Study Coordinator, 828-255-8008 ext. 2824

    Recruiting

  • Charleston Neuroscience Institute (Site 034)

    Beaufort, South Carolina, 29902

    Study Coordinator, 843-763-4466 ext. 1404

    Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

    Study Coordinator, 713-394-7576

    Recruiting

  • Pacific Northwest Retina

    Bellevue, Washington, 98004

    Study Coordinator, 206-215-3850

    Recruiting

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003

    Study Coordinator, 973-707-5632 ext. 1124

    Recruiting

  • NC Retina

    Cary, North Carolina, 27511

    Amanda Smith, 919-782-8038, asmith@ncretina.com

    Lekha Desai

    Recruiting

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

    Study Coordinator, 719-473-9595

    Recruiting

  • Connecticut Eye Consultants, P.C.

    Danbury, Connecticut, 06810

    Study Coordinator, 203-791-2020

    Recruiting

  • RSC Research LLC

    Denver, Colorado, 80222

    Study Coordinator, 720-443-2425

    Recruiting

  • Retina Consultants of Minnesota

    Edina, Minnesota, 55435

    Study Coordinator, 952-259-6262

    Recruiting

  • The Retina Partners

    Encino, California, 91436

    Jesus Vargas, 818-788-9333 ext. 1141, jesusv@theretinapartners.com

    Amir Guerami

    Recruiting

  • Erie Retina Research

    Erie, Pennsylvania, 16505

    Study Coordinator, 814-200-9152

    Recruiting

  • Palmetto Retina Center

    Florence, South Carolina, 29501

    Study Coordinator, 803-931-0077

    Recruiting

  • Retina Group of Florida

    Fort Myers, Florida, 33912

    Study Coordinator, 239-938-1284

    Recruiting

  • Texas Retina Associates

    Fort Worth, Texas, 76104

    Study Coordinator, 817-334-0882 ext. 405

    Recruiting

  • Associated Retina Consultants - Gilbert

    Gilbert, Arizona, 85259

    Study Coordinator, 602-242-4928

    Recruiting

  • Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY

    Great Neck, New York, 11021

    Study Coordinator, 516-466-0390

    Recruiting

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland, 21740

    Study Coordinator, 301-671-2400

    Recruiting

  • Graystone Eye

    Hickory, North Carolina, 28602

    Study Coordinator, 828-304-6643

    Recruiting

  • Southeastern Retina Associates

    Hixson, Tennessee, 37343

    KaSandra "Kassy" Schratter, 423-756-1002, kschratter@seretina.com

    Devon Ghodasra

    Recruiting

  • Southeastern Retina Associates (Site 095)

    Johnson City, Tennessee, 37604

    Study Coordinator, 423-578-4364

    Recruiting

  • Illinois Retina Associates

    Joliet, Illinois, 60435

    Study Coordinator, 815-744-7515

    Recruiting

  • Retina Consultants of Texas

    Katy, Texas, 77494

    Study Coordinator, 713-524-3434

    Recruiting

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37922

    Study Coordinator, 865-588-0811

    Recruiting

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

    Study Coordinator, 843-763-4466

    Recruiting

  • University Retina & Macula Associates, P.C.

    Lemont, Illinois, 60439

    Study Coordinator, 708-765-4110

    Recruiting

  • Retina Associates, LLC

    Lenexa, Kansas, 66215

    Study Coordinator, 913-831-7400

    Recruiting

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206

    Study Coordinator, 502-589-1500

    Recruiting

  • Retina Consultants, P.C.

    Manchester, Connecticut, 06042

    Study Coordinator, 860-646-7704

    Recruiting

  • Northern California Retina Vitreous Associates Medical Group, Inc.

    Mountain View, California, 94040

    Study Coordinator, 650-963-3465

    Recruiting

  • Tennessee Retina

    Nashville, Tennessee, 37203

    Study Coordinator, 615-983-6000

    Recruiting

  • Florida Retina Institute

    Orlando, Florida, 32806

    Study Coordinator, 407-849-9621

    Recruiting

  • Maine Eye Center (Site 097)

    Portland, Maine, 04101

    Study Coordinator, 207-523-5548

    Recruiting

  • Retina Consultants of Southern Colorado

    Pueblo, Colorado, 81008

    Study Coordinator, 719-473-9595

    Recruiting

  • Vistar Eye Center (Site 129)

    Roanoke, Virginia, 24019

    Study Coordinator, 540-342-3400

    Recruiting

  • Retina Associates of Western NY, PC (Site 051)

    Rochester, New York, 14620

    Study Coordinator, 585-450-2082

    Recruiting

  • Austin Retina Associates

    Round Rock, Texas, 78681

    Study Coordinator, 800-252-8259

    Recruiting

  • Retina Consultants, LLC

    Salem, Oregon, 97302

    Study Coordinator, 503-371-4350

    Recruiting

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

    Study Coordinator, 210-903-1046 ext. 2051

    Recruiting

  • Austin Retina Associates

    San Marcos, Texas, 78666

    Study Coordinator, 512-451-0103

    Recruiting

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

    Study Coordinator, 714-972-8432

    Recruiting

  • Retina Group of Florida (Site 065)

    Sarasota, Florida, 34232

    Study Coordinator, 941-924-0303

    Recruiting

  • Retina Consultants of Texas

    Schertz, Texas, 78154

    Study Coordinator, 210-693-1063

    Recruiting

  • Retina Research Institute at New England Retina Consultants, PC

    Springfield, Massachusetts, 01107

    Study Coordinator, 413-732-2333

    Recruiting

  • Cascade Medical Research Institute, LLC

    Springfield, Oregon, 97477

    Study Coordinator, 541-687-1927

    Recruiting

  • NC Retina Associates

    Wake Forest, North Carolina, 27587

    Amanda Smith, 919-782-8038, asmith@ncretina.com

    John Thordsen

    Recruiting

  • Retina Group of New England

    Waterford, Connecticut, 06385

    Study Coordinator, 860-444-1292

    Recruiting

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

    Study Coordinator, 803-744-0158

    Recruiting

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

    Study Coordinator, 515-223-8686

    Recruiting

  • Salt Lake Retina

    West Jordan, Utah, 84088

    Study Coordinator, 801-679-4173

    Recruiting

  • Center for Retina and Macular Disease (Site 062)

    Winter Haven, Florida, 33880

    Study Coordinator, 863-297-5400 ext. 2020

    Recruiting

Other trials in United States

Czechia5 sites, 5 recruiting

  • Klaudians Hospital - Ophthalmology department

    Mladá Boleslav, 293 01

    Study Coordinator, 420731542840

    Recruiting

  • VISUS spol. s r.o.

    Náchod, 54701

    Study Coordinator, 420775270681

    Recruiting

  • Axon Clinical, s.r.o. (Site 400)

    Prague, 150 00

    Study Coordinator, 420 602171106

    Recruiting

  • Astra Clinic.s.r.o.

    Prague, 184 00

    Study Coordinator, 420724728981

    Recruiting

  • Fakultni nemocnice Kralovske

    Prague, PSČ 100 34

    Study Coordinator, 420 267162913

    Recruiting

Other trials in Czechia

Colombia4 sites, 4 recruiting

  • Clinica Oftalmologica del Caribe (COFCA)

    Barranquilla, 080001 - Atlantico

    Study Coordinator, 57 3043909153

    Recruiting

  • Fundacion Oftalmologica Nacional

    Bogotá, 110231 - D.C.

    Study Coordinator, 57 3108790322

    Recruiting

  • Clínica Imbanaco S.A.S

    Cali, 760042

    Study Coordinator, 57 3004764838

    Recruiting

  • Clinica de Oftalmologia Sandiego

    Medellín, 050021 - Antioquia

    Study Coordinator, 57 3136997380

    Recruiting

Other trials in Colombia

France3 sites, 3 recruiting

  • Hopital Intercommunal De Creteil

    Créteil, 94010

    Study Coordinator, (+33) 1 570 23068

    Recruiting

  • Centre d'Ophtalmologie Paradis-Monticelli

    Marseille, 13008

    Study Coordinator, +33 4 91 16 05 84

    Recruiting

  • Centre Ophtalmologique Saint Exupéry

    Saint-Cyr-sur-Loire, 37540

    Study Coordinator, (+33) 6 2633 1609

    Recruiting

Other trials in France

Portugal2 sites, 2 recruiting

  • AIBILI Azinhaga de Santa Comba

    Coimbra, 3000-548

    Study Coordinator, 351 239 480127

    Recruiting

  • Espaço Médico de Coimbra

    Coimbra, 3030-163

    Study Coordinator, 00 351 965439405

    Recruiting

Other trials in Portugal

Spain2 sites, 2 recruiting

  • Hospital General de Catalunya

    Barcelona, 8195

    Study Coordinator, (+34)937071936

    Recruiting

  • Oftalvist

    Burjassot -(Valencia), 46100

    Study Coordinator, (+34)674757868

    Recruiting

Other trials in Spain

Brazil1 site, 1 recruiting

  • IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia (Site 332)

    São Paulo, 04038-032

    Study Coordinator, 5511 3016-4096

    Recruiting

Other trials in Brazil

Hungary1 site, 1 recruiting

  • Budapest Retina Associates

    Budapest, 1133

    Study Coordinator, +36-30-230-9177

    Recruiting

Other trials in Hungary

Italy1 site, 1 recruiting

  • Presidio Ospedaliero Universitario "Santa Maria della Misericordia" Clinica Oculistica - Padiglione 7 - Piano 3

    Udine, 33100

    Study Coordinator, (+39) 0432 559905

    Recruiting

Other trials in Italy

About this study

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)

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.

Being tested
Tiespectus, Aflibercept
Medical subject headings
Macular Degeneration, Choroidal Neovascularization, Wet Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TiespectusDrug

    Also called EYE201, MK-8748

    Administered by intravitreal (IVT) injection

  • AfliberceptDrug

    Also called Eylea®

    Administered by intravitreal (IVT) injection

Study groups in NCT07496567
Study groupRoleWhat they receive
Tiespectus Low DoseExperimentalParticipants receive 3 initial administrations of tiespectus low dose every 4 weeks (Q4W), then continue to receive tiespectus low dose every 8weeks (Q8W) until week 48. After week48, participants will be treated at intervals determined based on individualized response to treatment, up to week 92.
Receives: Drug: Tiespectus
Tiespectus High DoseExperimentalParticipants receive 3 initial administrations of tiespectus high dose Q4W, then continue to receive tiespectus high dose Q8W until week48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 92
Receives: Drug: Tiespectus
Aflibercept 2 mgActive comparatorParticipants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92
Receives: Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1

    Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. Mean change in ETDRS letters from baseline to Year 1 will be assessed.

    Measured: Baseline and Year 1

Secondary outcomes (10)

  1. Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time to Year 1

    Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. The mean change in BCVA from baseline over time to year 1 will be assessed.

    Measured: Up to Year 1

  2. Proportion of Participants Who Gain ≥5 ETDRS Letters at Year 1

    Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.

    Measured: Year 1

  3. Proportion of Participants Who Gain ≥10 ETDRS Letters at Year 1

    Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.

    Measured: Year 1

  4. Proportion of Participants Who Gain ≥15 ETDRS Letters at Year 1

    Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.

    Measured: Year 1

  5. Proportion of Participants Who Lose ≥5 ETDRS Letters at Year 1

    Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.

    Measured: Year 1

  6. Proportion of Participants Who Lose ≥10 ETDRS Letters at Year 1

    Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.

    Measured: Year 1

  7. Proportion of Participants Who Lose ≥15 ETDRS Letters at Year 1

    Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.

    Measured: Year 1

  8. Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Subfield Thickness (CST) From Baseline (Day 1) To Year 1

    CST will be measured in microns using SD-OCT. Mean change in CST from baseline to Year 1 will be assessed.

    Measured: Baseline and Year 1

  9. Number of Participants who Experience One or More Systemic Adverse Events (AEs)

    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal clinical laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: Up to approximately 96 weeks

  10. Number of Participants who Experience One or More Ocular AEs

    An ocular adverse event (OAE) is defined as any untoward medical occurrence involving the eye or ocular adnexa (including eyelids, conjunctiva, lacrimal apparatus, extraocular muscles, and orbit) that:

    Occurs or worsens after the first administration of the investigational product (IP) or a study-related ocular procedure, and does not necessarily have a causal relationship with the IP or procedure.

    OAEs include, but are not limited to, changes in: Symptoms (e.g., ocular pain, photophobia, floaters, blurred vision), Visual function (e.g., best-corrected visual acuity [BCVA], visual field). Intraocular pressure (IOP), Anterior segment findings (e.g., conjunctival hyperemia, keratitis, anterior chamber inflammation), Posterior segment findings (e.g., vitreous inflammation, retinal hemorrhages, retinal tears or detachment, macular edema), or ocular adnexa (e.g., eyelid edema, ptosis).

    Measured: Up to approximately 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start15 Apr 2026
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
960 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07496567
Sponsor's protocol ID
8748-003
Other IDs
MK-8748-003
Acronym
TORRONTES
Status last verified
Aug 2026
First submitted
23 Mar 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tiespectus and Aflibercept in people with Macular Degeneration and Age-Related Macular Degeneration, run by EyeBiotech Ltd. at 71 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Czechia, Colombia, France, Portugal and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1 (time frame: Baseline and Year 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07496567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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