960 Participants NeededMy employer runs this trial

Tiespectus for Age-Related Macular Degeneration

(TORRONTES Trial)

Recruiting at 70 trial locations
TF
Overseen ByToll Free Number
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

MD

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

I have not received treatment for new blood vessel growth in my eye from AMD.
I was diagnosed with wet age-related macular degeneration within the last 21 days.

Exclusion Criteria

History of uveitis in either eye
I have had macular laser treatment in my study eye before.
I have had VEGF or other eye injections in my study eye before.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 initial administrations of tiespectus or aflibercept every 4 weeks, then continue every 8 weeks until week 48

48 weeks
3 visits (in-person) every 4 weeks, then every 8 weeks

Extended Treatment

Participants continue treatment at intervals determined based on individualized response to treatment, up to week 92

44 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Tiespectus Low DoseExperimental Treatment1 Intervention
Group II: Tiespectus High DoseExperimental Treatment1 Intervention
Group III: Aflibercept 2 mgActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

EyeBiotech Ltd.

Lead Sponsor

Trials
3
Recruited
1,100+

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 ...

Merck 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 ( ...