Comparing tiespectus (MK-8748) with aflibercept for wet age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2/3 trial enrolls treatment‑naive patients with choroidal neovascularization secondary to AMD and randomizes them to receive intravitreal tiespectus (MK-8748) or aflibercept. Eligible participants must have a diagnosis of neovascular AMD made within 21 days before starting treatment. Patients will receive regular in‑office eye injections and follow-up visits with vision testing and retinal imaging to track response. The trial is being run at several retina clinics in the United States.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Network Arizona / Retina Macula Institute of Arizona
  Scottsdale, Arizona, United States Recruiting
• Retina Center of Arkansas
  Fayetteville, Arkansas, United States Recruiting
• Retina Partners of Northwest Arkansas, PLLC
  Springdale, Arkansas, United States Recruiting
• Global Research Management, Inc.
  Glendale, California, United States Recruiting
• Retinal Consultants Medical Group (Site 024)
  Modesto, California, United States Recruiting
• Azul Vision / California Eye Specialists Medical Group, Inc.
  Pasadena, California, United States Recruiting

+82 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tiespectus (MK-8748) versus aflibercept to treat neovascular (wet) age-related macular degeneration

  The study will see if tiespectus (MK-8748) works as well as aflibercept for people with newly diagnosed neovascular (wet) age-related macular degeneration.

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• Evaluating a stem cell treatment for geographic atrophy from dry age-related macular degeneration.

  This study is testing a new stem cell treatment for people with geographic atrophy from dry age-related macular degeneration to see if it can help improve their vision.

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• Understanding Age-Related Macular Degeneration and Its Progression

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• Using stem cells to treat retinal and optic nerve damage

  This study is testing if using stem cells from your own bone marrow can help improve vision in people with serious eye damage from conditions like age-related macular degeneration and optic nerve problems.

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• Blepharoptosis After Repeated Anti-VEGF Injections in One Eye

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.