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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
960
Administered by intravitreal (IVT) injection
Administered by intravitreal injection (IVT)
Retina Partners of Northwest Arkansas, PLLC
Springdale, Arkansas, United States
RECRUITINGGlobal Research Management, Inc.
Glendale, California, United States
RECRUITINGRetinal Consultants Medical Group (Site 024)
Modesto, California, United States
RECRUITINGRetina Consultants of Southern California (Site 043)
Redlands, California, United States
Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline 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. Mean change in ETDRS letters from baseline to Year 1 will be assessed.
Time frame: Baseline and Year 1
Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time 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.
Time frame: Up to Year 1
Proportion of Participants Who Gain ≥5 ETDRS Letters at 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.
Time frame: Year 1
Proportion of Participants Who Gain ≥10 ETDRS Letters at 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.
Time frame: Year 1
Proportion of Participants Who Gain ≥15 ETDRS Letters at 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.
Time frame: Year 1
Proportion of Participants Who Lose ≥5 ETDRS Letters at 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.
Time frame: Year 1
Proportion of Participants Who Lose ≥10 ETDRS Letters at 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.
Time frame: Year 1
Proportion of Participants Who Lose ≥15 ETDRS Letters at 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.
Time frame: Year 1
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Subfield Thickness (CST) From Baseline (Day 1) To Year 1
CST will be measured in microns using SD-OCT. Mean change in CST from baseline to Year 1 will be assessed.
Time frame: Baseline and Year 1
Number of Participants who Experience One or More Systemic Adverse Events (AEs)
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.
Time frame: Up to approximately 96 weeks
Number of Participants who Experience One or More Ocular AEs
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)
Time frame: Up to approximately 96 weeks
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Retinal Consultants Medical Group (Site 020)
Sacramento, California, United States
RECRUITINGRetinal Consultants Medical Group (Site 022)
Sacramento, California, United States
RECRUITINGRetina Group of Florida (Site 070)
Fort Lauderdale, Florida, United States
RECRUITINGFort Lauderdale Eye Institute (Site 042)
Plantation, Florida, United States
RECRUITINGRetina Vitreous Associates of Florida (Site 049)
St. Petersburg, Florida, United States
RECRUITINGRetina Associates of Florida, LLC
Tampa, Florida, United States
RECRUITING...and 20 more locations