Diabetic Macular Edema (DME)Phase 3ALTONCT07734844
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
A Phase 3 study testing Tabirafusp tedromer and Aflibercept (2.0 mg) in people with Diabetic Macular Edema (DME), run by Kodiak Sciences Inc at 52 sites in 2 countries.
Trial summary
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- Tabirafusp tedromer and Aflibercept (2.0 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 910 participants
- Where
- 52 sitesin 2 countries
- Study dates
- 3 Aug 2026to Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
52 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
52 sites in 2 countries
United States44 sites, 44 recruiting
- Recruiting
Kodiak Research Center
Amarillo, Texas, 79106
- Recruiting
Kodiak Research Center
Arlington, Texas, 76012
- Recruiting
Kodiak Research Center
Austin, Texas, 78705
- Recruiting
Kodiak Research Center
Bakersfield, California, 93309
- Recruiting
Kodiak Research Center
Beaufort, South Carolina, 29902
- Recruiting
Kodiak Research Center
Bellaire, Texas, 77401
- Recruiting
Kodiak Research Center
Bellevue, Washington, 98004
- Recruiting
Kodiak Research Center
Cary, North Carolina, 27511
- Recruiting
Kodiak Research Center
Charleston, South Carolina, 29414
- Recruiting
Kodiak Research Center
Elmhurst, Illinois, 60126
- Recruiting
Kodiak Research Center
Fort Lauderdale, Florida, 33308
- Recruiting
Kodiak Research Center
Fort Worth, Texas, 76104
- Recruiting
Kodiak Research Center
Glendale, California, 91204
- Recruiting
Kodiak Research Center
Greensboro, North Carolina, 27401
- Recruiting
Kodiak Research Center
Hagerstown, Maryland, 21740
- Recruiting
Kodiak Research Center
Hauppauge, New York, 11788
- Recruiting
Kodiak Research Center
Hickory, North Carolina, 28602
- Recruiting
Kodiak Research Center
Katy, Texas, 77494
- Recruiting
Kodiak Research Center
Ladson, South Carolina, 29456
- Recruiting
Kodiak Research Center
Lynchburg, Virginia, 24502
- Recruiting
Kodiak Research Center
Madison, Mississippi, 39110
- Recruiting
Kodiak Research Center
Modesto, California, 95356
- Recruiting
Kodiak Research Center
Mt. Pleasant, South Carolina, 29464
- Recruiting
Kodiak Research Center
Oxnard, California, 93036
- Recruiting
Kodiak Research Center
Pasadena, California, 91107
- Recruiting
Kodiak Research Center
Plano, Texas, 75075
- Recruiting
Kodiak Research Center
Redlands, California, 92373
- Recruiting
Kodiak Research Center
Redlands, California, 92374
- Recruiting
Kodiak Research Center
Rochester, New York, 14620
- Recruiting
Kodiak Research Center
Round Rock, Texas, 78681
- Recruiting
Kodiak Research Center
Sacramento, California, 95825
- Recruiting
Kodiak Research Center
Sacramento, California, 95841
- Recruiting
Kodiak Research Center
Saint Louis Park, Minnesota, 55416
- Recruiting
Kodiak Research Center
San Antonio, Texas, 78240
- Recruiting
Kodiak Research Center
Schertz, Texas, 78154
- Recruiting
Kodiak Research Center
Scottsdale, Arizona, 85255
- Recruiting
Kodiak Research Center
Sioux Falls, South Dakota, 57108
- Recruiting
Kodiak Research Center
St. Petersburg, Florida, 33711
- Recruiting
Kodiak Research Center
The Woodlands, Texas, 77384
- Recruiting
Kodiak Research Center
Wake Forest, North Carolina, 27587
- Recruiting
Kodiak Research Center
Waterford, Connecticut, 06385
- Recruiting
Kodiak Research Center
West Columbia, South Carolina, 29169
- Recruiting
Kodiak Research Center
Winston-Salem, North Carolina, 27587
- Recruiting
Kodiak Research Center
Winter Haven, Florida, 33880
Argentina8 sites, 8 recruiting
- Recruiting
Kodiak Research Center
Caba, Buenos Aires, 1015
- Recruiting
Kodiak Research Center
Caba, Buenos Aires, C1023AAQ
- Recruiting
Kodiak Research Center
Caba, Buenos Aires, C1061
- Recruiting
Kodiak Research Center
Caba, Buenos Aires, C1121ABB
- Recruiting
Kodiak Research Center
Comodoro Rivadavia, Chubut Province, 9000
- Recruiting
Kodiak Research Center
Mendoza, Mendoza Province, 5500
- Recruiting
Kodiak Research Center
Rosario, Santa Fe Province, 2000
- Recruiting
Kodiak Research Center
Rosario, Santa Fe Province, S2000DSK
About this study
Official title: A Randomized, Double-masked, Active-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Tedromer 5 mg Compared With Intravitreal Aflibercept 2 mg in Participants With Visual Impairment Secondary to Diabetic Macular Edema (DME) - ALTO
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- Tabirafusp tedromer, Aflibercept (2.0 mg)
- Keywords
- DME, KSI-501, tabirafusp tedromer, aflibercept, antibody biopolymer conjugate, anti-VEGF, anti-IL-6, Kodiak Sciences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tabirafusp tedromerDrug
Also called KSI-501
Intravitreal injection
Aflibercept (2.0 mg)Drug
Also called Eylea
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Tabirafusp tedromer 5 mg Q8W | Experimental | Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing) Receives: Drug: Tabirafusp tedromer |
| Tabirafusp tedromer 5 mg Q4-24W | Experimental | Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by individualized dosing every 4 to 24 weeks. Receives: Drug: Tabirafusp tedromer |
| Aflibercept 2 mg | Active comparator | Intravitreal injection of aflibercept once every 4 weeks for 5 monthly doses followed by every-8-week dosing Receives: Drug: Aflibercept (2.0 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA)
Mean change in BCVA from Day 1 to Year 1
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start3 Aug 2026
- Primary completion31 Aug 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 5:3:5 into one of three treatment groups: tabirafusp-ted Q8W; tabirafusp-ted Q4-24W; or aflibercept.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 910 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kodiak Sciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Pablo Velazquez-Martin, MD, Study director, Kodiak Sciences Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734844
- Sponsor's protocol ID
- KSMP002-S1
- Acronym
- ALTO
- Status last verified
- Aug 2026
- First submitted
- 30 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Active-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Tedromer 5 mg Compared With Intravitreal Aflibercept 2 mg in Participants With Visual Impairment Secondary to Diabetic Macular Edema (DME) - ALTO
- ClinicalTrials.gov ID
- NCT07734844
- Acronym / sponsor ID
- ALTO / KSMP002-S1
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- DME, KSI-501, tabirafusp tedromer, aflibercept, antibody biopolymer conjugate, anti-VEGF, anti-IL-6, Kodiak Sciences
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 910 participants (estimated)
- Lead sponsor
- Kodiak Sciences IncIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized 5:3:5 into one of three treatment groups: tabirafusp-ted Q8W; tabirafusp-ted Q4-24W; or aflibercept.
| Arm | Type | Receives |
|---|---|---|
| Tabirafusp tedromer 5 mg Q8W | Experimental | Drug: Tabirafusp tedromerIntravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing) |
| Tabirafusp tedromer 5 mg Q4-24W | Experimental | Drug: Tabirafusp tedromerIntravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by individualized dosing every 4 to 24 weeks. |
| Aflibercept 2 mg | Active comparator | Drug: Aflibercept (2.0 mg)Intravitreal injection of aflibercept once every 4 weeks for 5 monthly doses followed by every-8-week dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tabirafusp tedromerAlso: KSI-501Intravitreal injection | Drug | Tabirafusp tedromer 5 mg Q4-24W, Tabirafusp tedromer 5 mg Q8W |
| Aflibercept (2.0 mg)Also: EyleaIntravitreal injection | Drug | Aflibercept 2 mg |
Primary outcome
Best corrected visual acuity (BCVA)
Time frame: Week 52
Mean change in BCVA from Day 1 to Year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
J. Pablo Velazquez-Martin, MD study director
Kodiak Sciences Inc
52 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tabirafusp tedromer and Aflibercept (2.0 mg) in people with Diabetic Macular Edema (DME), run by Kodiak Sciences Inc at 52 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kodiak Sciences Inc (6502810850, ClinicalTrials@kodiak.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (BCVA) (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.