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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8748-003 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiespectus Low Dose | Experimental | 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. |
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| Tiespectus High Dose | Experimental | 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 |
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| Aflibercept 2 mg | Active Comparator | Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiespectus | Drug | Administered by intravitreal (IVT) injection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Year 1 |
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The main inclusion criteria include but are not limited to the following:
The main exclusion criteria include but are not limited to the following
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants - Gilbert | Recruiting | Gilbert | Arizona | 85259 | United States |
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| Aflibercept | Drug | Administered by intravitreal (IVT) injection |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | Up to approximately 96 weeks |
| The Retina Partners | Recruiting | Encino | California | 91436 | United States |
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| Northern California Retina Vitreous Associates Medical Group, Inc. | Recruiting | Mountain View | California | 94040 | United States |
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| Retina Consultants of Southern Colorado | Recruiting | Colorado Springs | Colorado | 80909 | United States |
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| RSC Research LLC | Recruiting | Denver | Colorado | 80222 | United States |
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| Retina Consultants of Southern Colorado | Recruiting | Pueblo | Colorado | 81008 | United States |
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| Connecticut Eye Consultants, P.C. | Recruiting | Danbury | Connecticut | 06810 | United States |
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| Retina Consultants, P.C. | Recruiting | Manchester | Connecticut | 06042 | United States |
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| Retina Group of New England | Recruiting | Waterford | Connecticut | 06385 | United States |
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| Retina Group of Florida | Recruiting | Fort Myers | Florida | 33912 | United States |
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| Florida Retina Institute | Recruiting | Orlando | Florida | 32806 | United States |
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| Retina Group of Florida (Site 065) | Recruiting | Sarasota | Florida | 34232 | United States |
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| Center for Retina and Macular Disease (Site 062) | Recruiting | Winter Haven | Florida | 33880 | United States |
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| Illinois Retina Associates | Recruiting | Joliet | Illinois | 60435 | United States |
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| University Retina & Macula Associates, P.C. | Recruiting | Lemont | Illinois | 60439 | United States |
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| Wolfe Eye Clinic | Recruiting | West Des Moines | Iowa | 50266 | United States |
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| Retina Associates, LLC | Recruiting | Lenexa | Kansas | 66215 | United States |
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| Butchertown Clinical Trials | Recruiting | Louisville | Kentucky | 40206 | United States |
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| Maine Eye Center (Site 097) | Recruiting | Portland | Maine | 04101 | United States |
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| Mid Atlantic Retina Specialists | Recruiting | Hagerstown | Maryland | 21740 | United States |
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| Retina Research Institute at New England Retina Consultants, PC | Recruiting | Springfield | Massachusetts | 01107 | United States |
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| Retina Consultants of Minnesota | Recruiting | Edina | Minnesota | 55435 | United States |
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| Envision Ocular, LLC | Recruiting | Bloomfield | New Jersey | 07003 | United States |
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| Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY | Recruiting | Great Neck | New York | 11021 | United States |
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| Retina Associates of Western NY, PC (Site 051) | Recruiting | Rochester | New York | 14620 | United States |
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| Asheville Eye Associates, Retina Division (Site 077) | Recruiting | Asheville | North Carolina | 28803 | United States |
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| NC Retina | Recruiting | Cary | North Carolina | 27511 | United States |
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| Graystone Eye | Recruiting | Hickory | North Carolina | 28602 | United States |
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| NC Retina Associates | Recruiting | Wake Forest | North Carolina | 27587 | United States |
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| Erie Retina Research | Recruiting | Erie | Pennsylvania | 16505 | United States |
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| Charleston Neuroscience Institute (Site 034) | Recruiting | Beaufort | South Carolina | 29902 | United States |
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| Palmetto Retina Center | Recruiting | Florence | South Carolina | 29501 | United States |
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| Charleston Neuroscience Institute | Recruiting | Ladson | South Carolina | 29456 | United States |
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| Palmetto Retina Center | Recruiting | West Columbia | South Carolina | 29169 | United States |
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| Southeastern Retina Associates | Recruiting | Hixson | Tennessee | 37343 | United States |
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| Southeastern Retina Associates (Site 095) | Recruiting | Johnson City | Tennessee | 37604 | United States |
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| Southeastern Retina Associates, P.C. | Recruiting | Knoxville | Tennessee | 37922 | United States |
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| Tennessee Retina | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Retina Consultants of Texas | Recruiting | Bellaire | Texas | 77401 | United States |
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| Texas Retina Associates | Recruiting | Fort Worth | Texas | 76104 | United States |
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| Retina Consultants of Texas | Recruiting | Katy | Texas | 77494 | United States |
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| Austin Retina Associates | Recruiting | Round Rock | Texas | 78681 | United States |
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| Retina Consultants of Texas | Recruiting | San Antonio | Texas | 78240 | United States |
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| Austin Retina Associates | Recruiting | San Marcos | Texas | 78666 | United States |
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| Retina Consultants of Texas | Recruiting | Schertz | Texas | 78154 | United States |
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| Salt Lake Retina | Recruiting | West Jordan | Utah | 84088 | United States |
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| Vistar Eye Center (Site 129) | Recruiting | Roanoke | Virginia | 24019 | United States |
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| Pacific Northwest Retina | Recruiting | Bellevue | Washington | 98004 | United States |
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| IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia (Site 332) | Recruiting | São Paulo | 04038-032 | Brazil |
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| Clinica Oftalmologica del Caribe (COFCA) | Recruiting | Barranquilla | 080001 - Atlantico | Colombia |
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| Fundacion Oftalmologica Nacional | Recruiting | Bogotá | 110231 - D.C. | Colombia |
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| Clinica de Oftalmologia Sandiego | Recruiting | Medellín | 050021 - Antioquia | Colombia |
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| Klaudians Hospital - Ophthalmology department | Recruiting | Mladá Boleslav | 293 01 | Czechia |
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| VISUS spol. s r.o. | Recruiting | Náchod | 54701 | Czechia |
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| Axon Clinical, s.r.o. (Site 400) | Recruiting | Prague | 150 00 | Czechia |
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| Hopital Intercommunal De Creteil | Recruiting | Créteil | 94010 | France |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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