A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Purpose
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.
Conditions
- Macular Degeneration
- Age-Related Macular Degeneration
- Choroidal Neovascularization
- Wet Macular Degeneration
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tiespectus Low Dose |
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. |
|
|
Experimental Tiespectus High Dose |
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 |
|
|
Active Comparator Aflibercept 2 mg |
Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92 |
|
Recruiting Locations
Springdale, Arkansas 72764
Glendale, California 91204
Modesto, California 95356
Redlands, California 92374
Sacramento, California 95825
Sacramento, California 95841
Fort Lauderdale, Florida 33308
Plantation, Florida 33324
St. Petersburg, Florida 33711
Tampa, Florida 33609
Tampa, Florida 33617
Oak Park, Illinois 60304
Hagerstown, Maryland 21740
Grand Rapids, Michigan 49546
Madison, Mississippi 39110
Hauppauge, New York 11788
Liverpool, New York 13088
Tulsa, Oklahoma 74114
Portland, Oregon 97225
Aiken, South Carolina 29803
Bluffton, South Carolina 29910
Charleston, South Carolina 29414
Abilene, Texas 79606
Austin, Texas 78705
Austin, Texas 78705
Plano, Texas 75075
The Woodlands, Texas 77384
Salt Lake City, Utah 84107
Lynchburg, Virginia 24502
Burlington, Washington 98233
More Details
- NCT ID
- NCT07440225
- Status
- Recruiting
- Sponsor
- EyeBiotech Ltd.