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Evaluating new treatments for wet age-related macular degeneration

A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Phase 3 Interventional Kodiak Sciences Inc · NCT06556368

This study is testing two new treatments for wet age-related macular degeneration to see if they can improve vision better than the current standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment675 (estimated)
Ages50 Years and up
SexAll
SponsorKodiak Sciences Inc Industry-sponsored
Drugs / interventionsTarcocimab
Locations76 sites (Gilbert, Arizona and 75 other locations)
Trial IDNCT06556368 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of two investigational treatments, Tarcocimab tedromer and Tabirafusp tedromer, in comparison to Aflibercept for patients suffering from neovascular (wet) age-related macular degeneration (wAMD). Participants will be treatment-naïve individuals with active choroidal neovascularization, and their visual acuity will be measured to determine eligibility. The study will involve multiple locations in Arizona, focusing on the impact of these new therapies on vision improvement and disease progression.

Who should consider this trial

Good fit: Ideal candidates for this study are treatment-naïve patients with active choroidal neovascularization due to wet AMD and a specific range of visual acuity.

Not a fit: Patients with severe vision loss in the non-study eye or significant fibrosis or atrophy affecting the foveal center of the study eye may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new effective treatment options for patients with wet age-related macular degeneration, potentially improving their vision and quality of life.

How similar studies have performed: Other studies have shown promise with similar approaches in treating wet AMD, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the Study Eye at Screening
* 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.
* Capable of giving signed informed consent.

Exclusion Criteria:

* BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular)
* Fibrosis or atrophy of \>50% of the lesion size and/or involving the foveal center of the Study Eye at Screening

Where this trial is running

Gilbert, Arizona and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Wet Age-related Macular DegenerationWet AMDKSI-301KSI-501TarcocimabTabirafuspAfliberceptAntibody biopolymer conjugate
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.