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

EyeBiotech

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Choroidal Neovascularization; Age-Related Macular Degeneration; Macular Degeneration; Wet Macular Degeneration

Treatments: Drug: Tiespectus; Drug: Aflibercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT07496567

8748-003

MK-8748-003 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 960 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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960 participants in 3 patient groups

Tiespectus Low Dose

Experimental group

Description:

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.

Treatment:

Drug: Tiespectus

Tiespectus High Dose

Experimental group

Description:

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

Treatment:

Drug: Tiespectus

Aflibercept 2 mg

Active Comparator group

Description:

Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92

Treatment:

Drug: Aflibercept