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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

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 8weeks (Q8W) until week 48. After week48, 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 week48. 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 (IVT) injection
    Other names:
    • Eylea®

Recruiting Locations

Associated Retina Consultants - Gilbert
Gilbert, Arizona 85259
Contact:
Study Coordinator
602-242-4928

The Retina Partners
Encino, California 91436
Contact:
Jesus Vargas
818-788-9333
jesusv@theretinapartners.com

Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California 94040
Contact:
Study Coordinator
650-963-3465

Retina Consultants of Southern Colorado
Colorado Springs, Colorado 80909
Contact:
Study Coordinator
719-473-9595

RSC Research LLC
Denver, Colorado 80222
Contact:
Study Coordinator
720-443-2425

Retina Consultants of Southern Colorado
Pueblo, Colorado 81008
Contact:
Study Coordinator
719-473-9595

Connecticut Eye Consultants, P.C.
Danbury, Connecticut 06810
Contact:
Study Coordinator
203-791-2020

Retina Consultants, P.C.
Manchester, Connecticut 06042
Contact:
Study Coordinator
860-646-7704

Retina Group of New England
Waterford, Connecticut 06385
Contact:
Study Coordinator
860-444-1292

Retina Group of Florida
Fort Myers, Florida 33912
Contact:
Study Coordinator
239-938-1284

Florida Retina Institute
Orlando, Florida 32806
Contact:
Study Coordinator
407-849-9621

Retina Group of Florida (Site 065)
Sarasota, Florida 34232
Contact:
Study Coordinator
941-924-0303

Center for Retina and Macular Disease (Site 062)
Winter Haven, Florida 33880
Contact:
Study Coordinator
863-297-5400

Illinois Retina Associates
Joliet, Illinois 60435
Contact:
Study Coordinator
815-744-7515

University Retina & Macula Associates, P.C.
Lemont, Illinois 60439
Contact:
Study Coordinator
708-765-4110

Retina Associates, LLC
Lenexa, Kansas 66215
Contact:
Study Coordinator
913-831-7400

Maine Eye Center (Site 097)
Portland, Maine 04101
Contact:
Study Coordinator
207-523-5548

Mid Atlantic Retina Specialists
Hagerstown, Maryland 21740
Contact:
Study Coordinator
301-671-2400

Retina Research Institute at New England Retina Consultants, PC
Springfield, Massachusetts 01107
Contact:
Study Coordinator
413-732-2333

Retina Consultants of Minnesota
Edina, Minnesota 55435
Contact:
Study Coordinator
952-259-6262

Envision Ocular, LLC
Bloomfield, New Jersey 07003
Contact:
Study Coordinator
973-707-5632

Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY
Great Neck, New York 11021
Contact:
Study Coordinator
516-466-0390

Retina Associates of Western NY, PC (Site 051)
Rochester, New York 14620
Contact:
Study Coordinator
585-450-2082

Asheville Eye Associates, Retina Division (Site 077)
Asheville, North Carolina 28803
Contact:
Study Coordinator
828-255-8008

NC Retina
Cary, North Carolina 27511
Contact:
Amanda Smith
919-782-8038
asmith@ncretina.com

Graystone Eye
Hickory, North Carolina 28602
Contact:
Study Coordinator
828-304-6643

NC Retina Associates
Wake Forest, North Carolina 27587
Contact:
Amanda Smith
919-782-8038
asmith@ncretina.com

Erie Retina Research
Erie, Pennsylvania 16505
Contact:
Study Coordinator
814-200-9152

Charleston Neuroscience Institute (Site 034)
Beaufort, South Carolina 29902
Contact:
Study Coordinator
843-763-4466

Palmetto Retina Center
Florence, South Carolina 29501
Contact:
Study Coordinator
803-931-0077

Charleston Neuroscience Institute
Ladson, South Carolina 29456
Contact:
Study Coordinator
843-763-4466

Palmetto Retina Center
West Columbia, South Carolina 29169
Contact:
Study Coordinator
803-744-0158

Southeastern Retina Associates
Hixson, Tennessee 37343
Contact:
KaSandra "Kassy" Schratter
423-756-1002
kschratter@seretina.com

Southeastern Retina Associates (Site 095)
Johnson City, Tennessee 37604
Contact:
Study Coordinator
423-578-4364

Southeastern Retina Associates, P.C.
Knoxville, Tennessee 37922
Contact:
Study Coordinator
865-588-0811

Tennessee Retina
Nashville, Tennessee 37203
Contact:
Study Coordinator
615-983-6000

Retina Consultants of Texas
Bellaire, Texas 77401
Contact:
Study Coordinator
713-394-7576

Texas Retina Associates
Fort Worth, Texas 76104
Contact:
Study Coordinator
817-334-0882

Retina Consultants of Texas
Katy, Texas 77494
Contact:
Study Coordinator
713-524-3434

Austin Retina Associates
Round Rock, Texas 78681
Contact:
Study Coordinator
800-252-8259

Retina Consultants of Texas
San Antonio, Texas 78240
Contact:
Study Coordinator
210-903-1046

Austin Retina Associates
San Marcos, Texas 78666
Contact:
Study Coordinator
512-451-0103

Retina Consultants of Texas
Schertz, Texas 78154
Contact:
Study Coordinator
210-693-1063

Salt Lake Retina
West Jordan, Utah 84088
Contact:
Study Coordinator
801-679-4173

Vistar Eye Center (Site 129)
Roanoke, Virginia 24019
Contact:
Study Coordinator
540-342-3400

Pacific Northwest Retina
Bellevue, Washington 98004
Contact:
Study Coordinator
206-215-3850

More Details

Status
Recruiting
Sponsor
EyeBiotech Ltd.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.