Tiespectus (MK-8748) versus aflibercept to treat neovascular (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 Phase 2/3 interventional trial compares the investigational agent tiespectus (MK-8748) with the approved anti-VEGF drug aflibercept in people with treatment-naive neovascular AMD. Eligible participants must have a new diagnosis of choroidal neovascularization related to AMD made within 21 days and will receive intravitreal injections of one of the two treatments with scheduled follow-up visits to monitor vision and retinal status. Key exclusion criteria include uncontrolled blood pressure, uncontrolled glaucoma, recent intraocular surgery, history of uveitis, prior macular laser in the study eye, or other active retinal disease. The trial is being run at multiple retina centers in the United States to collect safety and effectiveness data across sites.

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

• Associated Retina Consultants - Gilbert
  Gilbert, Arizona, United States Recruiting
• The Retina Partners
  Encino, California, United States Recruiting
• Northern California Retina Vitreous Associates Medical Group, Inc.
  Mountain View, California, United States Recruiting
• Orange County Retina Medical Group
  Santa Ana, California, United States Recruiting
• Retina Consultants of Southern Colorado
  Colorado Springs, Colorado, United States Recruiting
• RSC Research LLC
  Denver, Colorado, United States Recruiting

+21 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.

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

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

  Recruiting at 132 sites Phase 2/3 EyeBiotech Ltd. · Scottsdale, Arizona and 131 other locations · NCT07440225

• Watching a short video before anti-VEGF eye injections

  This trial will test whether watching a brief procedural video before a first anti-VEGF intravitreal injection helps people with retinal diseases feel less anxious and have fewer or smaller subconjunctival hemorrhages.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07002372

• 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.

  Recruiting at 3 sites Phase 1/2 Eyestem Research Pvt. Ltd. · Jālna, Maharashtra and 2 other locations · NCT06394232

• Understanding Age-Related Macular Degeneration and Its Progression

  This study looks at how age-related macular degeneration develops and progresses by comparing people with the condition to healthy individuals, using non-invasive tests and personal feedback.

  Recruiting Center for Eye Research Australia · East Melbourne, Victoria · NCT04739319

• 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.

  Recruiting at 4 sites MD Stem Cells · Westport, Connecticut and 3 other locations · NCT03011541

• Blepharoptosis After Repeated Anti-VEGF Injections in One Eye

  This study tests whether repeated intravitreal anti-VEGF injections in one eye affect eyelid position compared with the untreated fellow eye.

  Recruiting Fatih Sultan Mehmet Training and Research Hospital · Istanbul · NCT07821450

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.