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

NCT07440225

RecruitingPhase 2, Phase 3

Sponsor: EyeBiotech Ltd.

Conditions: Macular Degeneration, Age-Related Macular Degeneration, Choroidal Neovascularization, Wet Macular Degeneration

Interventions: Tiespectus, Aflibercept

Countries: United States, Argentina, Australia, Israel, Latvia, Spain, Switzerland, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 50 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (91)
  • Scottsdale, Arizona, United States
  • Fayetteville, Arkansas, United States
  • Springdale, Arkansas, United States
  • Glendale, California, United States
  • Modesto, California, United States
  • Redlands, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Altamonte Springs, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Gainesville, Florida, United States
  • Plantation, Florida, United States
  • St. Petersburg, Florida, United States
  • Tallahassee, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Wildwood, Florida, United States
  • Oak Park, Illinois, United States
  • Springfield, Illinois, United States
  • Carmel, Indiana, United States
  • Hagerstown, Maryland, United States
  • Grand Rapids, Michigan, United States
  • Madison, Mississippi, United States
  • Cherry Hill, New Jersey, United States
  • Hauppauge, New York, United States
  • Liverpool, New York, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Tulsa, Oklahoma, United States
  • Portland, Oregon, United States
  • + 61 more on CT.gov