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

Phase
Phase 2/Phase 3
Recruitment status
Participants
Lead sponsor
EyeBiotech Ltd.
Start date
Number of sites

Summary
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.
Acronym
Short title
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)
Official title
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)

Control arm
Active comparator
Registry reports results
Listing at source
Recruitment status
Phase
Phase 2/Phase 3
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
EyeBiotech Ltd.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design

  1. Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1

    Timeframe: 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.

  1. Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time to Year 1

    Timeframe: 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.

  2. Proportion of Participants Who Gain ≥5 ETDRS Letters at Year 1

    Timeframe: 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.

  3. Proportion of Participants Who Gain ≥10 ETDRS Letters at Year 1

    Timeframe: 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.

  4. Proportion of Participants Who Gain ≥15 ETDRS Letters at Year 1

    Timeframe: 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.

  5. Proportion of Participants Who Lose ≥5 ETDRS Letters at Year 1

    Timeframe: 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.

  6. Proportion of Participants Who Lose ≥10 ETDRS Letters at Year 1

    Timeframe: 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.

  7. Proportion of Participants Who Lose ≥15 ETDRS Letters at Year 1

    Timeframe: 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.

  8. Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Subfield Thickness (CST) From Baseline (Day 1) To Year 1

    Timeframe: 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.

  9. Number of Participants who Experience One or More Systemic Adverse Events (AEs)

    Timeframe: 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.

  10. Number of Participants who Experience One or More Ocular AEs

    Timeframe: 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).

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Healthy volunteers
No

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
Sources for eligibility

  • Associated Retina Consultants - GilbertGilbert, United StatesRecruiting
  • The Retina PartnersEncino, United StatesRecruiting
  • Northern California Retina Vitreous Associates Medical Group, Inc.Mountain View, United StatesRecruiting
  • Orange County Retina Medical GroupSanta Ana, United StatesRecruiting
  • Retina Consultants of Southern ColoradoColorado Springs, United StatesRecruiting
  • RSC Research LLCDenver, United StatesRecruiting
  • Retina Consultants of Southern ColoradoPueblo, United StatesRecruiting
  • Connecticut Eye Consultants, P.C.Danbury, United StatesRecruiting
  • Retina Consultants, P.C.Manchester, United StatesRecruiting
  • Retina Group of New EnglandWaterford, United StatesRecruiting
  • Retina Group of FloridaFort Myers, United StatesRecruiting
  • Florida Retina InstituteOrlando, United StatesRecruiting
  • Retina Group of Florida (Site 065)Sarasota, United StatesRecruiting
  • Center for Retina and Macular Disease (Site 062)Winter Haven, United StatesRecruiting
  • Illinois Retina AssociatesJoliet, United StatesRecruiting
  • University Retina & Macula Associates, P.C.Lemont, United StatesRecruiting
  • Wolfe Eye ClinicWest Des Moines, United StatesRecruiting
  • Retina Associates, LLCLenexa, United StatesRecruiting
  • Butchertown Clinical TrialsLouisville, United StatesRecruiting
  • Maine Eye Center (Site 097)Portland, United StatesRecruiting
  • Mid Atlantic Retina SpecialistsHagerstown, United StatesRecruiting
  • Retina Research Institute at New England Retina Consultants, PCSpringfield, United StatesRecruiting
  • Retina Consultants of MinnesotaEdina, United StatesRecruiting
  • Envision Ocular, LLCBloomfield, United StatesRecruiting
  • Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NYGreat Neck, United StatesRecruiting

And 46 more, listed on the interactive page.

Sources for sites

Other registry identifiers

  • MK-8748-003
Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (2)