Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT07734844
Recruiting Phase 3

A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO

NCT07734844 · tracked via the Priya Life Science USA tracker
Sponsor
Kodiak Sciences Inc
Phase
Phase 3
Started
2026-08-03
Last updated
2026-08-21

Condition(s) studied

Diabetic Macular Edema (DME)

Investigational drug(s) / intervention(s)

Tabirafusp tedromer →Aflibercept (2.0 mg) →

Tabirafusp tedromer: Intravitreal injection

Aflibercept (2.0 mg): Intravitreal injection

Study summary

A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * DME, treatment-naïve or previously-treated * Male or female ≥18 years of age with Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12% * Capable of giving informed signed consent Exclusion Criteria: * Active iris or angle neovascularization or neovascular glaucoma in the Study Eye. * Current or history of retinal detachment (tractional or rhegmatogenous) in the Study Eye

Primary outcome measure(s)

  • Best corrected visual acuity (BCVA) — Week 52
    Mean change in BCVA from Day 1 to Year 1

Trial sites (9)

FacilityCityRegionStatus
Kodiak Research Center Glendale California Recruiting
Kodiak Research Center Pasadena California Recruiting
Kodiak Research Center St. Petersburg Florida Recruiting
Kodiak Research Center Hagerstown Maryland Recruiting
Kodiak Research Center Saint Louis Park Minnesota Recruiting
Kodiak Research Center Beaufort South Carolina Recruiting
Kodiak Research Center Charleston South Carolina Recruiting
Kodiak Research Center Ladson South Carolina Recruiting
Kodiak Research Center West Columbia South Carolina Recruiting

More Kodiak Sciences Inc trials in the USA

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) - DAYBREAK Active, not recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK Recruiting

Other trials for the same condition

A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema Recruiting
Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections Enrolling by invitation
A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME Active, not recruiting
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema Active, not recruiting
A Study to Evaluate the Efficacy and Safety of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07734844 on ClinicalTrials.gov ↗ ← All trials in the USA