A Phase 2/3 interventional study of Tiespectus and Aflibercept in Macular Degeneration, Age-Related Macular Degeneration and Choroidal Neovascularization, sponsored by EyeBiotech Ltd.. Recruiting at 71 sites in 9 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by EyeBiotech Ltd. (part of Merck & Co., Inc) · Phase 2/3, Interventional, and Treatment
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.
93 studies on the registry are indexed under Wet Macular Degeneration; 10 are open to participants now.
This study's planned enrollment of 960 is above the median of 101 across 74 interventional studies indexed under Wet Macular Degeneration.
Browse Wet Macular Degeneration studies →EyeBiotech Ltd. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
First submitted after EyeBiotech Ltd. became part of Merck & Co., Inc.
Compared within Wet Macular Degeneration, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Macular Degeneration. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The main inclusion criteria include but are not limited to the following:
The main exclusion criteria include but are not limited to the following
Participants 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.
Drug: Tiespectus
Participants 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
Drug: Tiespectus
Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92
Drug: Aflibercept
Administered by intravitreal (IVT) injection
Also known as: EYE201, MK-8748
Administered by intravitreal (IVT) injection
Also known as: Eylea®
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.
Time frame: Baseline and Year 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.
Time frame: Up to Year 1
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.
Time frame: Year 1
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.
Time frame: Year 1
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.
Time frame: Year 1
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.
Time frame: Year 1
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.
Time frame: Year 1
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.
Time frame: Year 1
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.
Time frame: Baseline and Year 1
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.
Time frame: Up to approximately 96 weeks
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).
Time frame: Up to approximately 96 weeks
Started Apr 2026 (actual). Primary completion is estimated for Jul 2028, 27 months after the start.
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Studies of the drug tested here: EYE201