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

ArmDescriptionAssigned 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.
  • Drug: Tiespectus
    Administered by intravitreal (IVT) injection
    Other names:
    • EYE201
    • MK-8748
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
  • Drug: Tiespectus
    Administered by intravitreal (IVT) injection
    Other names:
    • EYE201
    • MK-8748
Active Comparator
Aflibercept 2 mg 		Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92
  • Drug: Aflibercept
    Administered by intravitreal injection (IVT)
    Other names:
    • Eylea®

Recruiting Locations

Research Network Arizona / Retina Macula Institute of Arizona
Scottsdale, Arizona 85255
Contact:
Study Coordinator
602-613-5473

Retina Center of Arkansas
Fayetteville, Arkansas 72703
Contact:
Study Coordinator
479-234-4499

Retina Partners of Northwest Arkansas, PLLC
Springdale, Arkansas 72764
Contact:
Study Coordinator
479-408-4470

Global Research Management, Inc.
Glendale, California 91204
Contact:
818-246-2560

Retinal Consultants Medical Group (Site 024)
Modesto, California 95356
Contact:
Study Coordinator
209-521-6173

Retina Consultants of Southern California (Site 043)
Redlands, California 92374
Contact:
Study Coordinator
951-788-0222

Retinal Consultants Medical Group (Site 020)
Sacramento, California 95825
Contact:
Study Coordinator
916-974-9279

Retinal Consultants Medical Group (Site 022)
Sacramento, California 95841
Contact:
Study Coordinator
916-339-3650

Florida Eye Clinic (Site 130)
Altamonte Springs, Florida 32701
Contact:
Study Coordinator
407-775-7495

Retina Group of Florida (Site 070)
Fort Lauderdale, Florida 33308
Contact:
Study Coordinator
954-776-6880

Vitreo Retinal Associates
Gainesville, Florida 32607
Contact:
352-300-8412

Florida Retina Institute
Jacksonville, Florida 32216
Contact:
Study Coordinator
206-338-0248

Florida Retina Consultants
Lakeland, Florida 33805
Contact:
Study Coordinator
863-682-7474

Retina Care Specialists
Palm Beach Gardens, Florida 33410
Contact:
Study Coordinator
561-408-0853

Fort Lauderdale Eye Institute (Site 042)
Plantation, Florida 33324
Contact:
Study Coordinator
954-635-2861

Retina Vitreous Associates of Florida (Site 049)
St. Petersburg, Florida 33711
Contact:
Study Coordinator
727-323-0077

Southern Vitreoretinal Associates
Tallahassee, Florida 32308
Contact:
Study Coordinator
850-942-6700

Retina Associates of Florida, LLC
Tampa, Florida 33609
Contact:
Study Coordinator
616-438-9395

Retina Vitreous Associates of Florida
Tampa, Florida 33617
Contact:
Study Coordinator
813-987-2000

Wildwood Clinical Research / Florida Retina Institute
Wildwood, Florida 34785
Contact:
Study Coordinator
407-473-5596

Illinois Retina Associates
Oak Park, Illinois 60304
Contact:
Study Coordinator
872-222-0139

Springfield Clinic
Springfield, Illinois 62703
Contact:
Study Coordinator
217-528-7541

Associated Vitreoretinal and Uveitis Consultants
Carmel, Indiana 46032
Contact:
Study Coordinator
317-571-1501

Midwest Eye Institute
Carmel, Indiana 46032
Contact:
Study Coordinator
317-805-2152

Cumberland Valley Retina Consultants (Site 007)
Hagerstown, Maryland 21740
Contact:
Study Coordinator
301-665-1712

Foundation for Vision Research (Site 073)
Grand Rapids, Michigan 49546
Contact:
Study Coordinator
616-438-9395

Retina Consultants of Minnesota
Saint Louis Park, Minnesota 55416
Contact:
Study Coordinator
952-259-4285

Retina Specialists of Mississippi
Hattiesburg, Mississippi 39402
Contact:
Study Coordinator
601-255-0736

Mississippi Retina Associates (Site 084)
Madison, Mississippi 39110
Contact:
Study Coordinator
601-981-4091

Mid Atlantic Retina
Cherry Hill, New Jersey 08034
Contact:
Study Coordinator
215-928-3092

Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico 87109
Contact:
Study Coordinator
505-393-7483

ong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY (Site 105)
Hauppauge, New York 11788
Contact:
Study Coordinator
516-466-0390

Retina Vitreous Surgeons of CNY, PC (Site 033)
Liverpool, New York 13088
Contact:
Study Coordinator
315-445-8166

Piedmont Retina Specialists - Greensboro
Greensboro, North Carolina 27401
Contact:
Study Coordinator
336-369-7160

North Carolina Retina Associates
Greenville, North Carolina 27834
Contact:
Study Coordinator
919-782-8038

Piedmont Retina Specialists - Winston-Salem
Winston-Salem, North Carolina 27103
Contact:
Study Coordinator
336-397-9216

Cincinnati Eye Institute (Site 133)
Cincinnati, Ohio 45242
Contact:
Study Coordinator
513-569-3462

Retina Vitreous Center
Edmond, Oklahoma 73013
Contact:
Study Coordinator
405-607-6699

Tulsa Retina Consultants
Tulsa, Oklahoma 74114
Contact:
Study Coordinator
918-395-0872

Retina Northwest, PC
Portland, Oregon 97221
Contact:
Study Coordinator
971-865-2781

EyeHealth Northwest
Portland, Oregon 97225
Contact:
Study Coordinator
503-296-6484

Mid Atlantic Retina (Site 050)
Bethlehem, Pennsylvania 18017
Contact:
Study Coordinator
516-466-0390

Palmetto Retina Center
Aiken, South Carolina 29803
Contact:
Study Coordinator
803-867-7058

Charleston Neuroscience Institute - Bluffton (Site 124)
Bluffton, South Carolina 29910
Contact:
Study Coordinator
843-278-9938

Charleston Neuroscience Institute (Site 104)
Charleston, South Carolina 29414
Contact:
Study Coordinator
843-972-3857

Charleston Neuroscience Institute (CNI) d/b/a Retina Consultants of South Carolina
Mt. Pleasant, South Carolina 29464
Contact:
Study Coordinator
843-763-4466

Charles Retina Institute
Germantown, Tennessee 38138
Contact:
Study Coordinator
901-683-0399

Retina Research Institute of Texas (Site 010)
Abilene, Texas 79606
Contact:
Study Coordinator
325-690-4414

Southwest Retina Specialists
Amarillo, Texas 79106
Contact:
Study Coordinator
806-350-1113

Texas Retina Associates
Arlington, Texas 76012
Contact:
Study Coordinator
682-433-5453

Austin Research Center for Retina
Austin, Texas 78705
Contact:
Study Coordinator
512-454-5851

Austin Retina Associates (Site 012)
Austin, Texas 78705
Contact:
Study Coordinator
512-451-0103

Retina & Vitreous of Texas
Bellaire, Texas 77401
Contact:
Study Coordinator
281-249-9076

Texas Retina Associates
Dallas, Texas 75231
Contact:
Study Coordinator
800-695-6941

Texas Retina (Site 037)
Plano, Texas 75075
Contact:
Study Coordinator
469-560-0177

Retina Center of Texas
Southlake, Texas 76092
Contact:
Study Coordinator
817-865-6800

Retina Consultants of Texas (Site 014)
The Woodlands, Texas 77384
Contact:
Study Coordinator
713-524-3434

Strategic Clinical Research Group
Weatherford, Texas 76087
Contact:
Study Coordinator
682-703-4318

Retina Associates of Utah
Salt Lake City, Utah 84107
Contact:
Study Coordinator
801-312-2020

Piedmont Eye Center (Site 054)
Lynchburg, Virginia 24502
Contact:
Study Coordinator
434-947-3984

Pacific Northwest Retina (Site 112)
Burlington, Washington 98233
Contact:
Study Coordinator
360-205-5417

Spokane Eye Clinical Research (Site 075)
Spokane, Washington 99204
Contact:
Study Coordinator
509-990-9913

Retina Consultants, PLLC
Charleston, West Virginia 25301
Contact:
Study Coordinator
304-346-4400

Eye Clinic of Wisconsin
Wausau, Wisconsin 54403
Contact:
Study Coordinator
715-261-8500

Centro Oftalmologico Metropolitano
San Juan, Puerto Rico 00921
Contact:
Study Coordinator
787-692-1763

More Details

Status
Recruiting
Sponsor
EyeBiotech Ltd.

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com