AzTrials
AzTrials

Macular DegenerationPhase 2/3MALBECNCT07440225

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)

A Phase 2/3 study testing Tiespectus and Aflibercept in people with Macular Degeneration and Age-Related Macular Degeneration, run by EyeBiotech Ltd. at 132 sites in 12 countries.

Recruiting

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

Sites and contacts
Official record
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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
132 sitesin 12 countries
Study dates
27 Mar 2026to 30 Jun 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

132 sites in 12 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

132 sites in 12 countries

United States67 sites, 67 recruiting

  • Retina Research Institute of Texas (Site 010)

    Abilene, Texas, 79606

    Study Coordinator, 325-690-4414

    Recruiting

  • Palmetto Retina Center

    Aiken, South Carolina, 29803

    Study Coordinator, 803-867-7058

    Recruiting

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

    Study Coordinator, 505-393-7483

    Recruiting

  • Florida Eye Clinic (Site 130)

    Altamonte Springs, Florida, 32701

    Study Coordinator, 407-775-7495

    Recruiting

  • Southwest Retina Specialists

    Amarillo, Texas, 79106

    Study Coordinator, 806-350-1113

    Recruiting

  • Texas Retina Associates

    Arlington, Texas, 76012

    Study Coordinator, 682-433-5453

    Recruiting

  • Austin Research Center for Retina

    Austin, Texas, 78705

    Study Coordinator, 512-454-5851

    Recruiting

  • Austin Retina Associates (Site 012)

    Austin, Texas, 78705

    Study Coordinator, 512-451-0103

    Recruiting

  • Retina & Vitreous of Texas

    Bellaire, Texas, 77401

    Study Coordinator, 281-249-9076

    Recruiting

  • Mid Atlantic Retina (Site 050)

    Bethlehem, Pennsylvania, 18017

    Study Coordinator, 516-466-0390

    Recruiting

  • Charleston Neuroscience Institute - Bluffton (Site 124)

    Bluffton, South Carolina, 29910

    Study Coordinator, 843-278-9938

    Recruiting

  • Pacific Northwest Retina (Site 112)

    Burlington, Washington, 98233

    Study Coordinator, 360-205-5417

    Recruiting

  • Associated Vitreoretinal and Uveitis Consultants

    Carmel, Indiana, 46032

    Study Coordinator, 317-571-1501

    Recruiting

  • Midwest Eye Institute

    Carmel, Indiana, 46032

    Study Coordinator, 317-805-2152

    Recruiting

  • Charleston Neuroscience Institute (Site 104)

    Charleston, South Carolina, 29414

    Study Coordinator, 843-972-3857

    Recruiting

  • Retina Consultants, PLLC

    Charleston, West Virginia, 25301

    Study Coordinator, 304-346-4400

    Recruiting

  • Mid Atlantic Retina

    Cherry Hill, New Jersey, 08034

    Study Coordinator, 215-928-3092

    Recruiting

  • Cincinnati Eye Institute (Site 133)

    Cincinnati, Ohio, 45242

    Study Coordinator, 513-569-3462

    Recruiting

  • Texas Retina Associates

    Dallas, Texas, 75231

    Study Coordinator, 800-695-6941

    Recruiting

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

    Study Coordinator, 405-607-6699

    Recruiting

  • Retina Center of Arkansas

    Fayetteville, Arkansas, 72703

    Study Coordinator, 479-234-4499

    Recruiting

  • Retina Group of Florida (Site 070)

    Fort Lauderdale, Florida, 33308

    Study Coordinator, 954-776-6880

    Recruiting

  • Vitreo Retinal Associates

    Gainesville, Florida, 32607

    352-300-8412

    Recruiting

  • Charles Retina Institute

    Germantown, Tennessee, 38138

    Study Coordinator, 901-683-0399

    Recruiting

  • Global Research Management, Inc.

    Glendale, California, 91204

    818-246-2560

    Recruiting

  • Foundation for Vision Research (Site 073)

    Grand Rapids, Michigan, 49546

    Study Coordinator, 616-438-9395

    Recruiting

  • Piedmont Retina Specialists - Greensboro

    Greensboro, North Carolina, 27401

    Study Coordinator, 336-369-7160

    Recruiting

  • North Carolina Retina Associates

    Greenville, North Carolina, 27834

    Study Coordinator, 919-782-8038

    Recruiting

  • Cumberland Valley Retina Consultants (Site 007)

    Hagerstown, Maryland, 21740

    Study Coordinator, 301-665-1712

    Recruiting

  • Retina Specialists of Mississippi

    Hattiesburg, Mississippi, 39402

    Study Coordinator, 601-255-0736

    Recruiting

  • ong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY (Site 105)

    Hauppauge, New York, 11788

    Study Coordinator, 516-466-0390

    Recruiting

  • Florida Retina Institute

    Jacksonville, Florida, 32216

    Study Coordinator, 206-338-0248

    Recruiting

  • Florida Retina Consultants

    Lakeland, Florida, 33805

    Study Coordinator, 863-682-7474

    Recruiting

  • Retina Vitreous Surgeons of CNY, PC (Site 033)

    Liverpool, New York, 13088

    Study Coordinator, 315-445-8166

    Recruiting

  • Piedmont Eye Center (Site 054)

    Lynchburg, Virginia, 24502

    Study Coordinator, 434-947-3984

    Recruiting

  • Mississippi Retina Associates (Site 084)

    Madison, Mississippi, 39110

    Study Coordinator, 601-981-4091

    Recruiting

  • South Florida Retina Institute

    Miami, Florida, 33180

    Study Coordinator, 786-590-1777

    Recruiting

  • Retinal Consultants Medical Group (Site 024)

    Modesto, California, 95356

    Study Coordinator, 209-521-6173

    Recruiting

  • Charleston Neuroscience Institute (CNI) d/b/a Retina Consultants of South Carolina

    Mt. Pleasant, South Carolina, 29464

    Study Coordinator, 843-763-4466

    Recruiting

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

    Study Coordinator, 872-222-0139

    Recruiting

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

    Study Coordinator, 561-408-0853

    Recruiting

  • Azul Vision / California Eye Specialists Medical Group, Inc.

    Pasadena, California, 91107

    Study Coordinator, 661-609-2475

    Recruiting

  • Texas Retina (Site 037)

    Plano, Texas, 75075

    Study Coordinator, 469-560-0177

    Recruiting

  • Fort Lauderdale Eye Institute (Site 042)

    Plantation, Florida, 33324

    Study Coordinator, 954-635-2861

    Recruiting

  • Retina Northwest, PC

    Portland, Oregon, 97221

    Study Coordinator, 971-865-2781

    Recruiting

  • EyeHealth Northwest

    Portland, Oregon, 97225

    Study Coordinator, 503-296-6484

    Recruiting

  • Retina Consultants of Southern California (Site 043)

    Redlands, California, 92374

    Study Coordinator, 951-788-0222

    Recruiting

  • Retinal Consultants Medical Group (Site 020)

    Sacramento, California, 95825

    Study Coordinator, 916-974-9279

    Recruiting

  • Retinal Consultants Medical Group (Site 022)

    Sacramento, California, 95841

    Study Coordinator, 916-339-3650

    Recruiting

  • Retina Consultants of Minnesota

    Saint Louis Park, Minnesota, 55416

    Study Coordinator, 952-259-4285

    Recruiting

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107

    Study Coordinator, 801-312-2020

    Recruiting

  • Research Network Arizona / Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255

    Study Coordinator, 602-613-5473

    Recruiting

  • Retina Center of Texas

    Southlake, Texas, 76092

    Study Coordinator, 817-865-6800

    Recruiting

  • Spokane Eye Clinical Research (Site 075)

    Spokane, Washington, 99204

    Study Coordinator, 509-990-9913

    Recruiting

  • Retina Partners of Northwest Arkansas, PLLC

    Springdale, Arkansas, 72764

    Study Coordinator, 479-408-4470

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62703

    Study Coordinator, 217-528-7541

    Recruiting

  • Retina Vitreous Associates of Florida (Site 049)

    St. Petersburg, Florida, 33711

    Study Coordinator, 727-323-0077

    Recruiting

  • Southern Vitreoretinal Associates

    Tallahassee, Florida, 32308

    Study Coordinator, 850-942-6700

    Recruiting

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609

    Study Coordinator, 616-438-9395

    Recruiting

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617

    Study Coordinator, 813-987-2000

    Recruiting

  • Retina Consultants of Texas (Site 014)

    The Woodlands, Texas, 77384

    Study Coordinator, 713-524-3434

    Recruiting

  • Tulsa Retina Consultants

    Tulsa, Oklahoma, 74114

    Study Coordinator, 918-395-0872

    Recruiting

  • Tyler Retina Research Institute

    Tyler, Texas, 75703

    Study Coordinator, 903-597-4644

    Recruiting

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403

    Study Coordinator, 715-261-8500

    Recruiting

  • Strategic Clinical Research Group

    Weatherford, Texas, 76087

    Study Coordinator, 682-703-4318

    Recruiting

  • Wildwood Clinical Research / Florida Retina Institute

    Wildwood, Florida, 34785

    Study Coordinator, 407-473-5596

    Recruiting

  • Piedmont Retina Specialists - Winston-Salem

    Winston-Salem, North Carolina, 27103

    Study Coordinator, 336-397-9216

    Recruiting

Other trials in United States

Argentina20 sites, 20 recruiting

  • Centro de Ojos Quilmes

    Buenos Aires, B1878KDF

    Study Coordinator, 54 911 5161-5949

    Recruiting

  • Clinica Privada de Ojos

    Buenos Aires, B7600

    Study Coordinator, +54 9 2234 37-4385

    Recruiting

  • Fundacion Jorge Zambrano para la investigación, diagnostivo y tratamiento de enfermedades oculares (Site 302)

    Buenos Aires, C1023AAQ

    Study Coordinator, +54 9 11 5995-6857

    Recruiting

  • RSresearch (Site 308)

    Buenos Aires, C1033AAW

    Study Coordinator, +54 9 11 5994-4371

    Recruiting

  • Instituto Oftalmologico de Buenos Aires SA (Site 306)

    Buenos Aires, C1120AAN

    Study Coordinator, +54 9 11 4813-7795

    Recruiting

  • Centro Oftalmologico Dr Charles y Asociados (Site 300)

    Buenos Aires, C1121ABB

    Study Coordinator, +54 9 11 2282-8104

    Recruiting

  • Centro de Ojos Loria SRL (Site 312)

    Buenos Aires, CP1832

    Study Coordinator, 115857-7777

    Recruiting

  • Centro Oftalmológico Dr. Zas

    Buenos Aires, PC1023

    Study Coordinator

    Recruiting

  • Hospital Britanico- Microcentro

    Cdad. Autónoma de Buenos Aires, 1008

    Study Coordinator, +54 9 11 7123 -9245

    Recruiting

  • Instituto Donato

    Cdad. Autónoma de Buenos Aires, C1428

    Study Coordinator, +54 9 11 5344-1235

    Recruiting

  • Instituto de Microcirugía Ocular Córdoba (IMOC S.R.L) (Site 305)

    Córdoba, 5000

    Study Coordinator, +54 9 354 747-7922

    Recruiting

  • Centro Privado de Ojos Romagosa SA (Site 307)

    Córdoba, X5000AAI

    Study Coordinator, +54 9 295 452-7642

    Recruiting

  • Centrovision Clinica Oftalmologica

    Mendoza, 5500

    Study Coordinator, +54 9 261 509-7842

    Recruiting

  • Oftar Centro De Oftalmología en Mendoza

    Mendoza, 5500

    Study Coordinator, +54 9 261 501-1035

    Recruiting

  • Grupo Laser Vision (Rosario Eximer Laser Vision SA)

    Rosario, Santa Fe Province, S2000DLA

    Study Coordinator, +54 9 341 612-9382

    Recruiting

  • Oftalmología Global (Centro Médico Oftalmología Global) (Site 304)

    Rosario, Santa Fe Province, S2000DSK

    Study Coordinator, +54 9 341 617-3017

    Recruiting

  • Microcirugia Ocular Rosario (Site 310)

    Rosario, Santa Fe Province, S2000TC

    Study Coordinator, +54 9 341 361-8977

    Recruiting

  • Centro de la Visión (Site 309)

    Salta, A4400

    Study Coordinator, +54 9 387 605-6975

    Recruiting

  • Centro de la Visión

    Salta, A4400

    Study Coordinator, +54 9 387 605-6975

    Recruiting

  • Instituto Zeman Bardeci (Site 311)

    Salta, A4400

    Study Coordinator, +54 9 387 605-6975

    Recruiting

Other trials in Argentina

Australia9 sites, 9 recruiting

  • Eye Clinic Albury Wodonga (Site 425)

    Albury, 2640 NSW

    Study Coordinator, +61 2 9959 0053

    Recruiting

  • Retina and Eye Consultants

    Hurstville, 2220

    Study Coordinator, +61 2 9570 1622

    Recruiting

  • Retina and Macula Specialists

    Hurstville, Sydney, 2220 NSW

    Study Coordinator, +61 431210490

    Recruiting

  • Launceston Eye Doctors

    Launceston, 7250

    Study Coordinator, +61 422 466 330

    Recruiting

  • Nexus Eyecare

    Norwest, 2153 NSW

    Study Coordinator, +61 9680 9100

    Recruiting

  • Marsden Eye Specialists (Site 420)

    Parramatta, 2150, NSW

    Study Coordinator, + 61 2 9635 7077

    Recruiting

  • Marsden Eye Specialists (Site 423)

    Strathfield, 2135 NSW

    Study Coordinator, +61 2 9746 2988

    Recruiting

  • Sydney Eye Hospital (Site 426)

    Sydney, 2000 NSW

    Study Coordinator, +61 2 9382 7379

    Recruiting

  • Sydney Retina Clinic and Day Surgery (Site 424)

    Sydney, 2000, NSW

    Study Coordinator, +61 2 9570 1522

    Recruiting

Other trials in Australia

Israel8 sites, 8 recruiting

  • Barzilai Medical Center

    Ashkelon, 7830604

    Study Coordinator, +972 (0)54-8002038

    Recruiting

  • Rambam Health Corporation (Site 706)

    Haifa, 3109601

    Study Coordinator, +972 (0)50-2061061

    Recruiting

  • Carmel Medical Center (Site 704)

    Haifa, 3436212

    Study Coordinator, +972 (0)50-8154556

    Recruiting

  • Hadassah Medical Center Opthalmology Department (Site 701)

    Jerusalem, 9112001

    Study Coordinator, +972 (0)54-5510093

    Recruiting

  • Rabin Medical Center (Site 700)

    Petah Tikva, 49100

    Study Coordinator, +972 (0)52-5659744

    Recruiting

  • Sheba Medical Center (Site 707)

    Ramat Gan, 6265601

    Study Coordinator, +972 (0)53-2227937

    Recruiting

  • Kaplan Medical Center Ophthalmology Department (Site 705)

    Rehovot, 7661005

    Study Coordinator, +972 (0)50-6316266

    Recruiting

  • Shamir Medical Center (Site 703)

    Tsrifin, 7033001

    Study Coordinator, +972 (0)54-7541053

    Recruiting

Other trials in Israel

Poland7 sites, 7 recruiting

  • Oculomedica Eye Hospital

    Bydgoszcz, 85-157

    Study Coordinator, 48501275082

    Recruiting

  • Oftalmika Sp. z o.o.

    Bydgoszcz, 85-631

    Study Coordinator, 48606616655

    Recruiting

  • Profesorskie Centrum Medyczne Sp. z o.o.

    Gdansk, 80-180

    Study Coordinator, 48502453888

    Recruiting

  • Gabinet Okulistyczny Edward Wylęgała

    Katowice, 40-594

    Study Coordinator, +48 692613009

    Recruiting

  • Dietla Medical Center 19 Sp zoo

    Krakow, 31-070

    Study Coordinator, '+48 608088412

    Recruiting

  • Klinika okulistyczna w Olsztynie - Centrum Diagnostyki i Mikrochirurgii Oka Lens

    Olsztyn, 10-424

    Study Coordinator, 48691465320

    Recruiting

  • Caminomed Sp. zo.o

    Tarnowskie Góry, 42-600

    Study Coordinator, +48 881 343 481

    Recruiting

Other trials in Poland

Switzerland5 sites, 5 recruiting

  • University Hospital Basel, Eye Clinic

    Basel, CH-4031

    Study Coordinator, (+) 41791393928

    Recruiting

  • Swiss Eye Institute and Berner Augenklinik

    Bern, CH-3007

    Study Coordinator, (+) 41 31 311 12 22

    Recruiting

  • Vista Augenklinik Binningen

    Binnigen, CH-4102

    Study Coordinator, (+) 41 61426 6079

    Recruiting

  • Fondation Asile des aveugles (Hôpital Ophtalmique Jules-Gonin)

    Lausanne, CH-1004

    Study Coordinator, (+) 41 216 268 166

    Recruiting

  • Stadtspital Zurich Triemli Forschungszentrum Augenklinik

    Zurich, CH-8063

    Study Coordinator, (+) 41 44 416 42 80

    Recruiting

Other trials in Switzerland

Estonia4 sites, 4 recruiting

  • Silmaarst Krista Turman OÜ

    Tallinn, 10120

    Study Coordinator, +372 5207194

    Recruiting

  • East Tallinn Central Hospital

    Tallinn, 10138

    Study Coordinator, +372 53065184

    Recruiting

  • Silmalaser OÜ

    Tallinn, 11412

    Study Coordinator, +372 56207596

    Recruiting

  • Tartu University Hospital

    Tartu, 50406

    Study Coordinator, +372 53319751

    Recruiting

Other trials in Estonia

Latvia3 sites, 3 recruiting

  • P.Stradins clinical university hospital

    Riga, LV1002

    Study Coordinator, 37129106879

    Recruiting

  • Riga East University hospital, clinical centre Bikernieki

    Riga, LV1006

    Study Coordinator, (+) 37 126 520 449

    Recruiting

  • Northern Kurzeme Regional Hospital

    Ventspils, LV3601

    Study Coordinator, (+) 37126160330

    Recruiting

Other trials in Latvia

Spain3 sites, 3 recruiting

  • Clinica de Oftalmologia Barraquer

    Barcelona, 08021

    Study Coordinator, +34 932 095 311 ext. 2303

    Recruiting

  • Hospital Universitari Vall d'Hebron - despacho de coordinación de oftalmología. Planta 8, Edifici General

    Barcelona, 08035

    Study Coordinator, (+34) 674108369

    Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

    Study Coordinator, (+34)911916000

    Recruiting

Other trials in Spain

United Kingdom3 sites, 3 recruiting

  • University Hospitals of Leicester NHS Trust (Site 209)

    Leicester, LE1 5WW

    Study Coordinator, 447929873467

    Recruiting

  • South West Retina

    Liverpool, 2170 NSW

    Study Coordinator, +61 2 8778 9400

    Recruiting

  • London North West University Healthcare NHS Trust (LNWH) (Site 201)

    London, NW10 7NS

    Study Coordinator, 44208 453 2711

    Recruiting

Other trials in United Kingdom

Germany2 sites, 2 recruiting

  • Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde

    Hamburg, 20251

    Study Coordinator

    Recruiting

  • Augenzentrum am St. Franziskus Hospital Münster

    Münster, 48145

    Study Coordinator

    Recruiting

Other trials in Germany

Puerto Rico1 site, 1 recruiting

  • Centro Oftalmologico Metropolitano

    San Juan, 00921

    Study Coordinator, 787-692-1763

    Recruiting

Other trials in Puerto Rico

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 injection (IVT)

Study groups in NCT07440225
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 8 weeks (Q8W) until week 48. After week 48, 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 week 48. 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 Feb 2026
  2. Study start27 Mar 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 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
NCT07440225
Sponsor's protocol ID
8748-002
Acronym
MALBEC
Status last verified
Sep 2026
First submitted
23 Feb 2026
Last updated
2 Oct 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 132 sites in 12 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, Argentina, Australia, Israel, Poland and 7 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 NCT07440225.

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 2 Oct 2026.

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