A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003) (TORRONTES)

July 22, 2026 updated by: EyeBiotech Ltd.

A Randomized Double-masked, Multicenter, 3-arm, Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) EYE201/MK-8748 Compared to Aflibercept (2 mg) in Participants With Neovascular Age-related Macular Degeneration (NVAMD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
960

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04038-032
        • Recruiting
        • IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia (Site 332)
        • Contact:
          • Study Coordinator
          • Phone Number: 5511 3016-4096
  • Colombia
      • Barranquilla, Colombia, 080001 - Atlantico
        • Recruiting
        • Clinica Oftalmologica del Caribe (COFCA)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3043909153
      • Bogotá, Colombia, 110231 - D.C.
        • Recruiting
        • Fundacion Oftalmologica Nacional
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3108790322
      • Medellín, Colombia, 050021 - Antioquia
        • Recruiting
        • Clinica de Oftalmologia Sandiego
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3136997380
  • Czechia
      • Mladá Boleslav, Czechia, 293 01
        • Recruiting
        • Klaudians Hospital - Ophthalmology department
        • Contact:
          • Study Coordinator
          • Phone Number: 420731542840
      • Náchod, Czechia, 54701
        • Recruiting
        • VISUS spol. s r.o.
        • Contact:
          • Study Coordinator
          • Phone Number: 420775270681
      • Prague, Czechia, 150 00
        • Recruiting
        • Axon Clinical, s.r.o. (Site 400)
        • Contact:
          • Study Coordinator
          • Phone Number: 420 602171106
      • Prague, Czechia, 184 00
        • Recruiting
        • Astra Clinic.s.r.o.
        • Contact:
          • Study Coordinator
          • Phone Number: 420724728981
  • France
      • Créteil, France, 94010
        • Recruiting
        • Hopital Intercommunal De Creteil
        • Contact:
          • Study Coordinator
          • Phone Number: (+33) 1 570 23068
  • Hungary
      • Budapest, Hungary, 1133
        • Recruiting
        • Budapest Retina Associates
        • Contact:
          • Study Coordinator
          • Phone Number: +36-30-230-9177
  • Portugal
      • Coimbra, Portugal, 3000-548
        • Recruiting
        • AIBILI Azinhaga de Santa Comba
        • Contact:
          • Study Coordinator
          • Phone Number: 351 239 480127
  • Spain
      • Barcelona, Spain, 8195
        • Recruiting
        • Hospital General de Catalunya
        • Contact:
          • Study Coordinator
          • Phone Number: (+34)937071936
      • Burjassot -(Valencia), Spain, 46100
        • Recruiting
        • Oftalvist
        • Contact:
          • Study Coordinator
          • Phone Number: (+34)674757868
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85259
        • Recruiting
        • Associated Retina Consultants - Gilbert
        • Contact:
          • Study Coordinator
          • Phone Number: 602-242-4928
    • California
      • Encino, California, United States, 91436
        • Recruiting
        • The Retina Partners
        • Contact:
        • Principal Investigator:
          • Amir Guerami
      • Mountain View, California, United States, 94040
        • Recruiting
        • Northern California Retina Vitreous Associates Medical Group, Inc.
        • Contact:
          • Study Coordinator
          • Phone Number: 650-963-3465
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • Retina Consultants of Southern Colorado
        • Contact:
          • Study Coordinator
          • Phone Number: 719-473-9595
      • Denver, Colorado, United States, 80222
        • Recruiting
        • RSC Research LLC
        • Contact:
          • Study Coordinator
          • Phone Number: 720-443-2425
      • Pueblo, Colorado, United States, 81008
        • Recruiting
        • Retina Consultants of Southern Colorado
        • Contact:
          • Study Coordinator
          • Phone Number: 719-473-9595
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Recruiting
        • Connecticut Eye Consultants, P.C.
        • Contact:
          • Study Coordinator
          • Phone Number: 203-791-2020
      • Manchester, Connecticut, United States, 06042
        • Recruiting
        • Retina Consultants, P.C.
        • Contact:
          • Study Coordinator
          • Phone Number: 860-646-7704
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Retina Group of New England
        • Contact:
          • Study Coordinator
          • Phone Number: 860-444-1292
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Retina Group of Florida
        • Contact:
          • Study Coordinator
          • Phone Number: 239-938-1284
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Florida Retina Institute
        • Contact:
          • Study Coordinator
          • Phone Number: 407-849-9621
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Retina Group of Florida (Site 065)
        • Contact:
          • Study Coordinator
          • Phone Number: 941-924-0303
      • Winter Haven, Florida, United States, 33880
        • Recruiting
        • Center for Retina and Macular Disease (Site 062)
        • Contact:
          • Study Coordinator
          • Phone Number: 2020 863-297-5400
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Recruiting
        • Illinois Retina Associates
        • Contact:
          • Study Coordinator
          • Phone Number: 815-744-7515
      • Lemont, Illinois, United States, 60439
        • Recruiting
        • University Retina & Macula Associates, P.C.
        • Contact:
          • Study Coordinator
          • Phone Number: 708-765-4110
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Wolfe Eye Clinic
        • Contact:
          • Study Coordinator
          • Phone Number: 515-223-8686
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • Recruiting
        • Retina Associates, LLC
        • Contact:
          • Study Coordinator
          • Phone Number: 913-831-7400
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Recruiting
        • Butchertown Clinical Trials
        • Contact:
          • Study Coordinator
          • Phone Number: 502-589-1500
    • Maine
      • Portland, Maine, United States, 04101
        • Recruiting
        • Maine Eye Center (Site 097)
        • Contact:
          • Study Coordinator
          • Phone Number: 207-523-5548
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Mid Atlantic Retina Specialists
        • Contact:
          • Study Coordinator
          • Phone Number: 301-671-2400
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Recruiting
        • Retina Research Institute at New England Retina Consultants, PC
        • Contact:
          • Study Coordinator
          • Phone Number: 413-732-2333
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Retina Consultants of Minnesota
        • Contact:
          • Study Coordinator
          • Phone Number: 952-259-6262
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Recruiting
        • Envision Ocular, LLC
        • Contact:
          • Study Coordinator
          • Phone Number: 1124 973-707-5632
    • New York
      • Great Neck, New York, United States, 11021
        • Recruiting
        • Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY
        • Contact:
          • Study Coordinator
          • Phone Number: 516-466-0390
      • Rochester, New York, United States, 14620
        • Recruiting
        • Retina Associates of Western NY, PC (Site 051)
        • Contact:
          • Study Coordinator
          • Phone Number: 585-450-2082
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Asheville Eye Associates, Retina Division (Site 077)
        • Contact:
          • Study Coordinator
          • Phone Number: 2824 828-255-8008
      • Cary, North Carolina, United States, 27511
        • Recruiting
        • NC Retina
        • Contact:
        • Principal Investigator:
          • Lekha Desai
      • Hickory, North Carolina, United States, 28602
        • Recruiting
        • Graystone Eye
        • Contact:
          • Study Coordinator
          • Phone Number: 828-304-6643
      • Wake Forest, North Carolina, United States, 27587
        • Recruiting
        • NC Retina Associates
        • Contact:
        • Principal Investigator:
          • John Thordsen
    • Oregon
      • Salem, Oregon, United States, 97302
        • Recruiting
        • Retina Consultants, LLC
        • Contact:
          • Study Coordinator
          • Phone Number: 503-371-4350
      • Springfield, Oregon, United States, 97477
        • Recruiting
        • Cascade Medical Research Institute, LLC
        • Contact:
          • Study Coordinator
          • Phone Number: 541-687-1927
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • Erie Retina Research
        • Contact:
          • Study Coordinator
          • Phone Number: 814-200-9152
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Recruiting
        • Charleston Neuroscience Institute (Site 034)
        • Contact:
          • Study Coordinator
          • Phone Number: 1404 843-763-4466
      • Florence, South Carolina, United States, 29501
        • Recruiting
        • Palmetto Retina Center
        • Contact:
          • Study Coordinator
          • Phone Number: 803-931-0077
      • Ladson, South Carolina, United States, 29456
        • Recruiting
        • Charleston Neuroscience Institute
        • Contact:
          • Study Coordinator
          • Phone Number: 843-763-4466
      • West Columbia, South Carolina, United States, 29169
        • Recruiting
        • Palmetto Retina Center
        • Contact:
          • Study Coordinator
          • Phone Number: 803-744-0158
    • Tennessee
      • Hixson, Tennessee, United States, 37343
        • Recruiting
        • Southeastern Retina Associates
        • Contact:
        • Principal Investigator:
          • Devon Ghodasra
      • Johnson City, Tennessee, United States, 37604
        • Recruiting
        • Southeastern Retina Associates (Site 095)
        • Contact:
          • Study Coordinator
          • Phone Number: 423-578-4364
      • Knoxville, Tennessee, United States, 37922
        • Recruiting
        • Southeastern Retina Associates, P.C.
        • Contact:
          • Study Coordinator
          • Phone Number: 865-588-0811
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Retina
        • Contact:
          • Study Coordinator
          • Phone Number: 615-983-6000
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Retina Consultants of Texas
        • Contact:
          • Study Coordinator
          • Phone Number: 713-394-7576
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Retina Associates
        • Contact:
          • Study Coordinator
          • Phone Number: 405 817-334-0882
      • Katy, Texas, United States, 77494
        • Recruiting
        • Retina Consultants of Texas
        • Contact:
          • Study Coordinator
          • Phone Number: 713-524-3434
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Austin Retina Associates
        • Contact:
          • Study Coordinator
          • Phone Number: 800-252-8259
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Retina Consultants of Texas
        • Contact:
          • Study Coordinator
          • Phone Number: 2051 210-903-1046
      • San Marcos, Texas, United States, 78666
        • Recruiting
        • Austin Retina Associates
        • Contact:
          • Study Coordinator
          • Phone Number: 512-451-0103
      • Schertz, Texas, United States, 78154
        • Recruiting
        • Retina Consultants of Texas
        • Contact:
          • Study Coordinator
          • Phone Number: 210-693-1063
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Salt Lake Retina
        • Contact:
          • Study Coordinator
          • Phone Number: 801-679-4173
    • Virginia
      • Roanoke, Virginia, United States, 24019
        • Recruiting
        • Vistar Eye Center (Site 129)
        • Contact:
          • Study Coordinator
          • Phone Number: 540-342-3400
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Pacific Northwest Retina
        • Contact:
          • Study Coordinator
          • Phone Number: 206-215-3850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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®
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:
  • MK-8748
  • EYE201
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:
  • MK-8748
  • EYE201

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1
Time Frame: Baseline and Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. Mean change in ETDRS letters from baseline to Year 1 will be assessed.
Baseline and Year 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time to Year 1
Time Frame: Up to Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. The mean change in BCVA from baseline over time to year 1 will be assessed.
Up to Year 1
Proportion of Participants Who Gain ≥5 ETDRS Letters at Year 1
Time Frame: Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
Year 1
Proportion of Participants Who Gain ≥10 ETDRS Letters at Year 1
Time Frame: Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
Year 1
Proportion of Participants Who Gain ≥15 ETDRS Letters at Year 1
Time Frame: Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
Year 1
Proportion of Participants Who Lose ≥5 ETDRS Letters at Year 1
Time Frame: Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
Year 1
Proportion of Participants Who Lose ≥10 ETDRS Letters at Year 1
Time Frame: Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
Year 1
Proportion of Participants Who Lose ≥15 ETDRS Letters at Year 1
Time Frame: Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
Year 1
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Subfield Thickness (CST) From Baseline (Day 1) To Year 1
Time Frame: Baseline and Year 1
CST will be measured in microns using SD-OCT. Mean change in CST from baseline to Year 1 will be assessed.
Baseline and Year 1
Number of Participants who Experience One or More Systemic Adverse Events (AEs)
Time Frame: Up to approximately 96 weeks
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal clinical laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to approximately 96 weeks
Number of Participants who Experience One or More Ocular AEs
Time Frame: Up to approximately 96 weeks

An ocular adverse event (OAE) is defined as any untoward medical occurrence involving the eye or ocular adnexa (including eyelids, conjunctiva, lacrimal apparatus, extraocular muscles, and orbit) that:

Occurs or worsens after the first administration of the investigational product (IP) or a study-related ocular procedure, and does not necessarily have a causal relationship with the IP or procedure.

OAEs include, but are not limited to, changes in: Symptoms (e.g., ocular pain, photophobia, floaters, blurred vision), Visual function (e.g., best-corrected visual acuity [BCVA], visual field). Intraocular pressure (IOP), Anterior segment findings (e.g., conjunctival hyperemia, keratitis, anterior chamber inflammation), Posterior segment findings (e.g., vitreous inflammation, retinal hemorrhages, retinal tears or detachment, macular edema), or ocular adnexa (e.g., eyelid edema, ptosis).
Up to approximately 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EyeBiotech Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8748-003
  • MK-8748-003 (Other Identifier: MSD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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