Tiespectus for Age-Related Macular Degeneration
(TORRONTES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called tiespectus to determine its effectiveness for neovascular age-related macular degeneration (NVAMD), a serious eye condition that affects vision. Researchers aim to compare tiespectus with the usual treatment, aflibercept. Participants will receive either a low or high dose of tiespectus or the standard treatment, aflibercept, to assess their effectiveness. Individuals recently diagnosed with NVAMD who have not yet received treatment may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating tiespectus's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have previously received anti-VEGF therapy or other intravitreal therapy in the study eye, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tiespectus, also known as MK-8748 or EYE201, may help treat eye conditions like neovascular age-related macular degeneration (NVAMD). In earlier studies, researchers tested tiespectus in both low and high doses. These studies found improvements in vision and eye health without serious side effects, and participants generally tolerated both doses well.
No major safety issues have been reported so far, suggesting that tiespectus might be a safe option for treating NVAMD. However, this trial is in its later stages, meaning researchers have already collected some safety data but are still studying its effects in more detail.
These findings might help prospective participants make an informed decision about tiespectus when considering joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Tiespectus for age-related macular degeneration because it offers a potentially more personalized approach to treatment. Unlike current standard treatments like Aflibercept, which have a fixed dosing schedule, Tiespectus can be adjusted based on the individual's response after the initial phase. This means Tiespectus could maintain or improve vision with fewer injections, tailoring therapy to the patient's needs. Additionally, Tiespectus comes in both low and high doses, providing options that could better suit different severities of the condition.
What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?
Research has shown that tiespectus, a new treatment for neovascular age-related macular degeneration (NVAMD), appears promising. In this trial, participants will receive either a low or high dose of tiespectus. Studies found that about 94% of patients taking higher doses of tiespectus experienced stable or improved eye conditions over three months. This treatment supports eye health and stabilizes vision. Early results suggest tiespectus might work as well as aflibercept, another treatment option in this trial and a common treatment for NVAMD. Some patients have reported better vision and healthier eye tissue, with no serious side effects. Overall, tiespectus could be a promising option for people with NVAMD.12467
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for people recently diagnosed (within 21 days) with a specific type of age-related macular degeneration that causes abnormal blood vessels in the eye. Participants must not have had prior treatments like anti-VEGF injections, certain eye surgeries, or other major eye diseases in the study eye.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 3 initial administrations of tiespectus or aflibercept every 4 weeks, then continue every 8 weeks until week 48
Extended Treatment
Participants continue treatment at intervals determined based on individualized response to treatment, up to week 92
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tiespectus
Trial Overview
The study compares a new medicine called tiespectus (MK-8748/EYE201) to aflibercept, an existing standard treatment. Both are given as injections into the affected eye to see if tiespectus works as well as aflibercept for treating neovascular age-related macular degeneration.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
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
Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92
Find a Clinic Near You
Who Is Running the Clinical Trial?
EyeBiotech Ltd.
Lead Sponsor
Citations
Real-World Outcomes of Antiangiogenic Therapy in ...
Results: More than 80% of the eyes showed improvement in VA post-loading dose, along with a statistically significant reduction in CMT. The ...
NCT07440225 | A Clinical Trial of EYE201/MK-8748 in ...
The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD. Official Title. A Randomized Double-masked, Multicenter, 3-arm, ...
Merck Announces Initiation of Pivotal Phase 2b/3 Trial ...
“Despite available therapies, many patients with neovascular age-related macular degeneration remain at risk of further vision loss due to ...
4.
finance.yahoo.com
finance.yahoo.com/sectors/healthcare/articles/merck-announces-initiation-pivotal-phase-105000556.htmlMerck Announces Initiation of Pivotal Phase 2b/3 Trial ...
Merck Announces Initiation of Pivotal Phase 2b/3 Trial Evaluating MK-8748 (Tiespectus), an Investigational Bispecific Tie2 Agonist/VEGF ...
Novel Treatments for Age-Related Macular Degeneration - PMC
At 3 months, the percentage of patients who had no change or improvement in lesion size was 94% in the groups of higher doses (108–109.5 PU) ...
Safety Outcomes of Brolucizumab in Neovascular Age ... - PMC
Overall, the rates of moderate or severe visual acuity loss were comparable in patients treated with brolucizumab (7.4%) and aflibercept (7.7%).
Clinical Trial Update October 2025
Purpose: To assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral intravitreal ( ...
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