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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 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. |
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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 week 48. 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 |
|---|---|---|---|---|---|---|
| Research Network Arizona / Retina Macula Institute of Arizona | Recruiting | Scottsdale | Arizona | 85255 | United States |
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| Aflibercept | Drug | Administered by intravitreal injection (IVT) |
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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 |
| Retina Center of Arkansas | Recruiting | Fayetteville | Arkansas | 72703 | United States |
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| Retina Partners of Northwest Arkansas, PLLC | Recruiting | Springdale | Arkansas | 72764 | United States |
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| Global Research Management, Inc. | Recruiting | Glendale | California | 91204 | United States |
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| Retinal Consultants Medical Group (Site 024) | Recruiting | Modesto | California | 95356 | United States |
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| Retina Consultants of Southern California (Site 043) | Recruiting | Redlands | California | 92374 | United States |
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| Retinal Consultants Medical Group (Site 020) | Recruiting | Sacramento | California | 95825 | United States |
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| Retinal Consultants Medical Group (Site 022) | Recruiting | Sacramento | California | 95841 | United States |
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| Florida Eye Clinic (Site 130) | Recruiting | Altamonte Springs | Florida | 32701 | United States |
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| Retina Group of Florida (Site 070) | Recruiting | Fort Lauderdale | Florida | 33308 | United States |
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| Vitreo Retinal Associates | Recruiting | Gainesville | Florida | 32607 | United States |
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| Fort Lauderdale Eye Institute (Site 042) | Recruiting | Plantation | Florida | 33324 | United States |
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| Retina Vitreous Associates of Florida (Site 049) | Recruiting | St. Petersburg | Florida | 33711 | United States |
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| Southern Vitreoretinal Associates | Recruiting | Tallahassee | Florida | 32308 | United States |
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| Retina Associates of Florida, LLC | Recruiting | Tampa | Florida | 33609 | United States |
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| Retina Vitreous Associates of Florida | Recruiting | Tampa | Florida | 33617 | United States |
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| Wildwood Clinical Research / Florida Retina Institute | Recruiting | Wildwood | Florida | 34785 | United States |
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| Illinois Retina Associates | Recruiting | Oak Park | Illinois | 60304 | United States |
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| Associated Vitreoretinal and Uveitis Consultants | Recruiting | Carmel | Indiana | 46032 | United States |
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| Cumberland Valley Retina Consultants (Site 007) | Recruiting | Hagerstown | Maryland | 21740 | United States |
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| Foundation for Vision Research (Site 073) | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| Mississippi Retina Associates (Site 084) | Recruiting | Madison | Mississippi | 39110 | United States |
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| Mid Atlantic Retina | Recruiting | Cherry Hill | New Jersey | 08034 | United States |
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| ong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY (Site 105) | Recruiting | Hauppauge | New York | 11788 | United States |
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| Retina Vitreous Surgeons of CNY, PC (Site 033) | Recruiting | Liverpool | New York | 13088 | United States |
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| Piedmont Retina Specialists - Winston-Salem | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
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| Cincinnati Eye Institute (Site 133) | Recruiting | Cincinnati | Ohio | 45242 | United States |
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| Tulsa Retina Consultants | Recruiting | Tulsa | Oklahoma | 74114 | United States |
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| Retina Northwest, PC | Recruiting | Portland | Oregon | 97221 | United States |
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| EyeHealth Northwest | Recruiting | Portland | Oregon | 97225 | United States |
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| Mid Atlantic Retina (Site 050) | Recruiting | Bethlehem | Pennsylvania | 18017 | United States |
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| Palmetto Retina Center | Recruiting | Aiken | South Carolina | 29803 | United States |
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| Charleston Neuroscience Institute - Bluffton (Site 124) | Recruiting | Bluffton | South Carolina | 29910 | United States |
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| Charleston Neuroscience Institute (Site 104) | Recruiting | Charleston | South Carolina | 29414 | United States |
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| Charleston Neuroscience Institute (CNI) d/b/a Retina Consultants of South Carolina | Recruiting | Mt. Pleasant | South Carolina | 29464 | United States |
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| Charles Retina Institute | Recruiting | Germantown | Tennessee | 38138 | United States |
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| Retina Research Institute of Texas (Site 010) | Recruiting | Abilene | Texas | 79606 | United States |
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| Southwest Retina Specialists | Recruiting | Amarillo | Texas | 79106 | United States |
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| Texas Retina Associates | Recruiting | Arlington | Texas | 76012 | United States |
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| Austin Research Center for Retina | Recruiting | Austin | Texas | 78705 | United States |
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| Austin Retina Associates (Site 012) | Recruiting | Austin | Texas | 78705 | United States |
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| Retina & Vitreous of Texas | Recruiting | Bellaire | Texas | 77401 | United States |
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| Texas Retina Associates | Recruiting | Dallas | Texas | 75231 | United States |
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| Texas Retina (Site 037) | Recruiting | Plano | Texas | 75075 | United States |
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| Retina Center of Texas | Recruiting | Southlake | Texas | 76092 | United States |
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| Retina Consultants of Texas (Site 014) | Recruiting | The Woodlands | Texas | 77384 | United States |
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| Strategic Clinical Research Group | Recruiting | Weatherford | Texas | 76087 | United States |
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| Retina Associates of Utah | Recruiting | Salt Lake City | Utah | 84107 | United States |
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| Piedmont Eye Center (Site 054) | Recruiting | Lynchburg | Virginia | 24502 | United States |
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| Pacific Northwest Retina (Site 112) | Recruiting | Burlington | Washington | 98233 | United States |
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| Spokane Eye Clinical Research (Site 075) | Recruiting | Spokane | Washington | 99204 | United States |
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| Grupo Laser Vision (Rosario Eximer Laser Vision SA) | Recruiting | Rosario | Santa Fe Province | S2000DLA | Argentina |
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| OftalmologÃa Global (Centro Médico OftalmologÃa Global) (Site 304) | Recruiting | Rosario | Santa Fe Province | S2000DSK | Argentina |
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| Microcirugia Ocular Rosario (Site 310) | Recruiting | Rosario | Santa Fe Province | S2000TC | Argentina |
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| Centro de Ojos Quilmes | Recruiting | Buenos Aires | B1878KDF | Argentina |
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| Fundacion Jorge Zambrano para la investigación, diagnostivo y tratamiento de enfermedades oculares (Site 302) | Recruiting | Buenos Aires | C1023AAQ | Argentina |
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| RSresearch (Site 308) | Recruiting | Buenos Aires | C1033AAW | Argentina |
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| Instituto Oftalmologico de Buenos Aires SA (Site 306) | Recruiting | Buenos Aires | C1120AAN | Argentina |
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| Centro Oftalmologico Dr Charles y Asociados (Site 300) | Recruiting | Buenos Aires | C1121ABB | Argentina |
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| Centro de Ojos Loria SRL (Site 312) | Recruiting | Buenos Aires | CP1832 | Argentina |
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| Centro Oftalmológico Dr. Zas | Recruiting | Buenos Aires | PC1023 | Argentina |
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| Instituto Donato | Recruiting | Cdad. Autónoma de Buenos Aires | C1428 | Argentina |
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| Instituto de MicrocirugÃa Ocular Córdoba (IMOC S.R.L) (Site 305) | Recruiting | Córdoba | 5000 | Argentina |
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| Centro Privado de Ojos Romagosa SA (Site 307) | Recruiting | Córdoba | X5000AAI | Argentina |
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| Centrovision Clinica Oftalmologica | Recruiting | Mendoza | 5500 | Argentina |
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| Oftar Centro De OftalmologÃa en Mendoza | Recruiting | Mendoza | 5500 | Argentina |
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| Centro de la Visión (Site 309) | Recruiting | Salta | A4400 | Argentina |
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| Instituto Zeman Bardeci (Site 311) | Recruiting | Salta | A4400 | Argentina |
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| Eye Clinic Albury Wodonga (Site 425) | Recruiting | Albury | 2640 NSW | Australia |
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| Marsden Eye Specialists (Site 420) | Recruiting | Parramatta | 2150, NSW | Australia |
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| Marsden Eye Specialists (Site 423) | Recruiting | Strathfield | 2135 NSW | Australia |
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| Sydney Eye Hospital (Site 426) | Recruiting | Sydney | 2000 NSW | Australia |
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| Sydney Retina Clinic and Day Surgery (Site 424) | Recruiting | Sydney | 2000, NSW | Australia |
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| Barzilai Medical Center | Recruiting | Ashkelon | 7830604 | Israel |
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| Rambam Health Corporation (Site 706) | Recruiting | Haifa | 3109601 | Israel |
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| Carmel Medical Center (Site 704) | Recruiting | Haifa | 3436212 | Israel |
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| Hadassah Medical Center Opthalmology Department (Site 701) | Recruiting | Jerusalem | 9112001 | Israel |
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| Rabin Medical Center (Site 700) | Recruiting | Petah Tikva | 49100 | Israel |
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| Sheba Medical Center (Site 707) | Recruiting | Ramat Gan | 6265601 | Israel |
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| Kaplan Medical Center Ophthalmology Department (Site 705) | Recruiting | Rehovot | 7661005 | Israel |
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| Shamir Medical Center (Site 703) | Recruiting | Ẕerifin | 7033001 | Israel |
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| P.Stradins clinical university hospital | Recruiting | Riga | LV1002 | Latvia |
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| University Hospital Basel, Eye Clinic | Recruiting | Basel | CH-4031 | Switzerland |
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| Swiss Eye Institute and Berner Augenklinik | Recruiting | Bern | CH-3007 | Switzerland |
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| Vista Augenklinik Binningen | Recruiting | Binnigen | CH-4102 | Switzerland |
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| University Hospitals of Leicester NHS Trust (Site 209) | Recruiting | Leicester | LE1 5WW | United Kingdom |
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| London North West University Healthcare NHS Trust (LNWH) (Site 201) | Recruiting | London | NW10 7NS | United Kingdom |
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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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