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
Scottsdale, Arizona 85255
Study Coordinator
602-613-5473
Springdale, Arkansas 72764
Study Coordinator
479-408-4470
Glendale, California 91204
818-246-2560
Modesto, California 95356
Study Coordinator
209-521-6173
Redlands, California 92374
Study Coordinator
951-788-0222
Sacramento, California 95825
Study Coordinator
916-974-9279
Sacramento, California 95841
Study Coordinator
916-339-3650
Altamonte Springs, Florida 32701
Study Coordinator
407-775-7495
Fort Lauderdale, Florida 33308
Study Coordinator
954-776-6880
Gainesville, Florida 32607
352-300-8412
Plantation, Florida 33324
Study Coordinator
954-635-2861
St. Petersburg, Florida 33711
Study Coordinator
727-323-0077
Tampa, Florida 33609
Study Coordinator
616-438-9395
Tampa, Florida 33617
Study Coordinator
813-987-2000
Oak Park, Illinois 60304
Study Coordinator
872-222-0139
Carmel, Indiana 46032
Study Coordinator
317-571-1501
Hagerstown, Maryland 21740
Study Coordinator
301-665-1712
Grand Rapids, Michigan 49546
Study Coordinator
616-438-9395
Madison, Mississippi 39110
Study Coordinator
601-981-4091
Hauppauge, New York 11788
Study Coordinator
516-466-0390
Liverpool, New York 13088
Study Coordinator
315-445-8166
Winston-Salem, North Carolina 27103
Study Coordinator
336-397-9216
Cincinnati, Ohio 45242
Study Coordinator
513-569-3462
Tulsa, Oklahoma 74114
Study Coordinator
918-395-0872
Portland, Oregon 97221
Study Coordinator
971-865-2781
Portland, Oregon 97225
Study Coordinator
503-296-6484
Bethlehem, Pennsylvania 18017
Study Coordinator
516-466-0390
Aiken, South Carolina 29803
Study Coordinator
803-867-7058
Bluffton, South Carolina 29910
Study Coordinator
843-278-9938
Charleston, South Carolina 29414
Study Coordinator
843-972-3857
Germantown, Tennessee 38138
Study Coordinator
901-683-0399
Abilene, Texas 79606
Study Coordinator
325-690-4414
Amarillo, Texas 79106
Study Coordinator
806-350-1113
Arlington, Texas 76012
Study Coordinator
682-433-5453
Austin, Texas 78705
Study Coordinator
512-454-5851
Austin, Texas 78705
Study Coordinator
512-451-0103
Bellaire, Texas 77401
Study Coordinator
281-249-9076
Dallas, Texas 75231
Study Coordinator
800-695-6941
Plano, Texas 75075
Study Coordinator
469-560-0177
Southlake, Texas 76092
Study Coordinator
817-865-6800
The Woodlands, Texas 77384
Study Coordinator
713-524-3434
Weatherford, Texas 76087
Study Coordinator
682-703-4318
Salt Lake City, Utah 84107
Study Coordinator
801-312-2020
Lynchburg, Virginia 24502
Study Coordinator
434-947-3984
Burlington, Washington 98233
Study Coordinator
360-205-5417
Spokane, Washington 99204
Study Coordinator
509-990-9913
More Details
- Status
- Recruiting
- Sponsor
- EyeBiotech Ltd.