> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-of-eye201-mk-8748-in-people-with-macular-90b89db5-5302-42fb-ba5b-3d3437205ca8 > Record changed: 2026-10-13 # A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) NCT07440225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) Participants 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) Lead sponsor EyeBiotech Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) Start date 2026-03-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) Number of sites 110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Title and summary **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. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Acronym** MALBEC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Short title** A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Dates **Completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **First posted** 2026-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Primary completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Start date** 2026-03-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Size and sites **Participants** 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Planned participants** 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Number of sites** 110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Lead sponsor** EyeBiotech Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Identifiers **Registry ID** NCT07440225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **ClinicalTrials.gov ID** NCT07440225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Outcomes ### Primary outcomes 1. Mean Change in Best-Corrected Visual Acuity (BCVA) \[Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)\] From Baseline to Year 1 Timeframe: Baseline and 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. ### Secondary outcomes 1. Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time to Year 1 Timeframe: Up 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. 2. Proportion of Participants Who Gain ≥5 ETDRS Letters at Year 1 Timeframe: 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. 3. Proportion of Participants Who Gain ≥10 ETDRS Letters at Year 1 Timeframe: 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. 4. Proportion of Participants Who Gain ≥15 ETDRS Letters at Year 1 Timeframe: 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. 5. Proportion of Participants Who Lose ≥5 ETDRS Letters at Year 1 Timeframe: 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. 6. Proportion of Participants Who Lose ≥10 ETDRS Letters at Year 1 Timeframe: 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. 7. Proportion of Participants Who Lose ≥15 ETDRS Letters at Year 1 Timeframe: 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. 8. Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Subfield Thickness (CST) From Baseline (Day 1) To Year 1 Timeframe: Baseline and Year 1 CST will be measured in microns using SD-OCT. Mean change in CST from baseline to Year 1 will be assessed. 9. Number of Participants who Experience One or More Systemic Adverse Events (AEs) Timeframe: Up to approximately 96 weeks 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. 10. Number of Participants who Experience One or More Ocular AEs Timeframe: Up to approximately 96 weeks 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) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 50 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Sites - Research Network Arizona / Retina Macula Institute of ArizonaScottsdale, United StatesRecruiting - Retina Center of ArkansasFayetteville, United StatesRecruiting - Retina Partners of Northwest Arkansas, PLLCSpringdale, United StatesRecruiting - Global Research Management, Inc.Glendale, United StatesRecruiting - Retinal Consultants Medical Group (Site 024)Modesto, United StatesRecruiting - Retina Consultants of Southern California (Site 043)Redlands, United StatesRecruiting - Retinal Consultants Medical Group (Site 020)Sacramento, United StatesRecruiting - Retinal Consultants Medical Group (Site 022)Sacramento, United StatesRecruiting - Florida Eye Clinic (Site 130)Altamonte Springs, United StatesRecruiting - Retina Group of Florida (Site 070)Fort Lauderdale, United StatesRecruiting - Vitreo Retinal AssociatesGainesville, United StatesRecruiting - Florida Retina InstituteJacksonville, United StatesRecruiting - Retina Care SpecialistsPalm Beach Gardens, United StatesRecruiting - Fort Lauderdale Eye Institute (Site 042)Plantation, United StatesRecruiting - Retina Vitreous Associates of Florida (Site 049)St. Petersburg, United StatesRecruiting - Southern Vitreoretinal AssociatesTallahassee, United StatesRecruiting - Retina Associates of Florida, LLCTampa, United StatesRecruiting - Retina Vitreous Associates of FloridaTampa, United StatesRecruiting - Wildwood Clinical Research / Florida Retina InstituteWildwood, United StatesRecruiting - Illinois Retina AssociatesOak Park, United StatesRecruiting - Springfield ClinicSpringfield, United StatesRecruiting - Associated Vitreoretinal and Uveitis ConsultantsCarmel, United StatesRecruiting - Midwest Eye InstituteCarmel, United StatesRecruiting - Cumberland Valley Retina Consultants (Site 007)Hagerstown, United StatesRecruiting - Foundation for Vision Research (Site 073)Grand Rapids, United StatesRecruiting And 85 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07440225) ## Related records ### Drugs (1) - [Aflibercept](https://trialight.com/data/asset/aflibercept-6bb09e87-ca99-436b-8634-71b90510b8fb.md) ### Lead sponsors (1) - [EyeBiotech Ltd.](https://trialight.com/data/company/eyebiotech-ltd-f9e7412c-e280-452d-8432-26e5fabee9a4.md) ### Conditions (4) - [Age-related macular degeneration](https://trialight.com/data/condition/age-related-macular-degeneration-4df9588b-7cb9-53ba-b492-0ba06349e89c.md) - [Choroidal neovascularization](https://trialight.com/data/condition/choroidal-neovascularization-5e4d725e-9e65-52d5-8a90-0001a1196b7f.md) - [Macular degeneration](https://trialight.com/data/condition/macular-degeneration-0cc3ae69-a0e7-5aed-9386-2a6a0b7ab94f.md) Primary condition - [Wet macular degeneration](https://trialight.com/data/condition/wet-macular-degeneration-fce04054-9f5d-5a0b-8ba9-fb08ba7393ba.md) ### Targets (2) - [PGF](https://trialight.com/data/target/pgf-4fda0322-a74e-5a50-9f97-af000c418e8b.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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