675 Participants Needed

Tarcocimab + Tabirafusp for Wet Age-Related Macular Degeneration

(DAYBREAK Trial)

Recruiting at 74 trial locations
KS
Overseen ByKodiak Sciences Inc
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Kodiak Sciences Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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?

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug Tarcocimab + Tabirafusp different from other treatments for wet age-related macular degeneration?

Tarcocimab + Tabirafusp is unique because it combines two components, Tarcocimab Tedromer and Tabirafusp Tedromer, which may offer a novel approach to treating wet age-related macular degeneration by potentially targeting different pathways involved in the disease. This combination could provide a new option compared to the standard anti-angiogenesis therapies currently used for this condition.12345

Who Is on the Research Team?

PV

Pablo Velazquez-Martin, MD

Principal Investigator

Kodiak Sciences Inc

Are You a Good Fit for This Trial?

This trial is for individuals with wet age-related macular degeneration (wAMD). Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis of wAMD and meet certain health standards.

Inclusion Criteria

I have a specific type of untreated eye condition related to AMD that affects my vision.
BCVA ETDRS score between 78 and 25 letters (Snellen equivalent ~20/32 and 20/320) inclusive, in the Study Eye at screening and reconfirmed at Day 1
I am able to understand and sign the consent form.

Exclusion Criteria

My vision in my non-study eye is very poor or I only have one eye.
Over half of the lesion in my eye is scarred or has thinned, affecting the central vision area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravitreal injections of study drugs with varying schedules: Tabirafusp tedromer every 4 weeks for 4 doses, then every 8 weeks or individualized; Tarcocimab tedromer every 4 weeks for 4 doses, then individualized every 4 to 24 weeks; Aflibercept every 4 weeks for 3 doses, then every 8 weeks.

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tabirafusp Tedromer
  • Tarcocimab Tedromer
Trial Overview The study tests the effectiveness and safety of two drugs, Tarcocimab Tedromer and Tabirafusp Tedromer, against Aflibercept in treating wAMD. It's likely that patients will be randomly assigned to receive one of these treatments.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Tarcocimab tedromer 5 mg (KSI-301)Experimental Treatment1 Intervention
Group II: Tabirafusp tedromer 5 mg (KSI-501)Experimental Treatment1 Intervention
Group III: Aflibercept 2 mgActive Control1 Intervention

Tabirafusp Tedromer is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Kimmtrak for:
🇪🇺
Approved in European Union as Kimmtrak for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kodiak Sciences Inc

Lead Sponsor

Trials
9
Recruited
3,900+

Published Research Related to This Trial

Emerging treatments for dry age-related macular degeneration (AMD) focus on two main strategies: preventing cell loss through neuroprotection and oxidative damage prevention, and suppressing inflammation.
Current and potential therapies include neuroprotective drugs, micronutrient supplementation, visual cycle modulators, and anti-inflammatory agents, suggesting a combination approach may be most effective in managing AMD.
New approaches and potential treatments for dry age-related macular degeneration.Damico, FM., Gasparin, F., Scolari, MR., et al.[2022]
Eliminating senescent retinal pigment epithelium (RPE) cells may offer a new treatment strategy for age-related macular degeneration (AMD), particularly for the dry form, which currently has no FDA-approved therapies.
Using the MDM2-p53 inhibitor Nutlin-3a to clear these senescent cells showed promising results in reducing retinal degeneration in animal models, suggesting a novel approach to address both neovascular and dry AMD.
Targeting senescent retinal pigment epithelial cells facilitates retinal regeneration in mouse models of age-related macular degeneration.Chae, JB., Jang, H., Son, C., et al.[2022]
Emixustat and lampalizumab are two promising new classes of medications being studied for the treatment of dry age-related macular degeneration (AMD), with both showing positive results in phase 2 clinical trials.
Lampalizumab is currently undergoing a large phase 3 clinical trial, focusing on its effectiveness against geographic atrophy, a severe form of dry AMD.
Emixustat and Lampalizumab: Potential Therapeutic Options for Geographic Atrophy.Jack, LS., Sadiq, MA., Do, DV., et al.[2018]

Citations

New approaches and potential treatments for dry age-related macular degeneration. [2022]
Targeting senescent retinal pigment epithelial cells facilitates retinal regeneration in mouse models of age-related macular degeneration. [2022]
Emixustat and Lampalizumab: Potential Therapeutic Options for Geographic Atrophy. [2018]
Visual cycle modulators versus placebo or observation for the prevention and treatment of geographic atrophy due to age-related macular degeneration. [2021]
Pharmacologic Treatment of Wet Type Age-related Macular Degeneration; Current and Evolving Therapies. [2018]
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