Diabetic RetinopathyPhase 3GLOW2NCT06270836
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)
A Phase 3 study testing Tarcocimab in people with Diabetic Retinopathy, run by Kodiak Sciences Inc at 39 sites in 2 countries.
Trial summary
This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Tarcocimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 1 May 2024to 13 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Signed informed consent prior to participation in the study.
- Type 1 or 2 diabetes mellitus and HbA1c of ≤12%.
- DR in the Study Eye (DRSS as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for DR or DME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
- CST ≤320 microns and a BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the Study Eye at screening and confirmed at Day 1; OR
- CST >320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79 letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye at screening and confirmed at Day 1.
Who cannot join
- Prior PRP in the Study Eye.
- Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
- Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1.
- Prior intravitreal or periocular steroid in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1.
- Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye.
- History of vitreoretinal surgery in the Study Eye.
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- History of uveitis in either eye.
- Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
- Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT, or FP.
- Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or alter visual acuity during the study.
- Active or suspected ocular or periocular infection or inflammation.
- Women who are pregnant or lactating or intending to become pregnant during the study.
- History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
- Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
- Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥ 100 mmHg while at rest.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States38 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Panhandle Eye Group, LLP. - Southwest Retina Specialists
Amarillo, Texas, 79106
Asheville Eye Associates
Asheville, North Carolina, 28803
Southeast Retina Center
Augusta, Georgia, 30909
Austin Retina Associates, PLLC (Austin)
Austin, Texas, 78705-1169
Austin Research Center for Retina
Austin, Texas, 78705
Retina Consultants of Texas (Bellaire)
Bellaire, Texas, 77401
Pacific Northwest Retina (Bellevue)
Bellevue, Washington, 98004
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
Star Vision Research
Burleson, Texas, 76028
Associated Vitreoretinal and Uveitis Consultants
Carmel, Indiana, 46290
North Carolina Retina Associates (Cary)
Cary, North Carolina, 27511
Charleston Neuroscience Institute
Charleston, South Carolina, 29414
Erie Retina Research
Erie, Pennsylvania, 16507
Retina Group of Florida
Fort Lauderdale, Florida, 33308
Retina Consultants of Orange County
Fullerton, California, 92835
Charles Retina Institute
Germantown, Tennessee, 38138
Global Research Management, Inc. - Lugene Eye Institute
Glendale, California, 91204
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Retina Consultants of Nevada
Henderson, Nevada, 89052
Retina Consultants of Texas (Katy)
Katy, Texas, 77494
Southeastern Retina Associates PC
Knoxville, Tennessee, 37922
Piedmont Eye Center
Lynchburg, Virginia, 24502
Florida Eye Associates
Melbourne, Florida, 32901
Retinal Consultants Medical Group, Inc.
Modesto, California, 95356
Texas Retina Associates
Plano, Texas, 75075
Retina Consultants of Southern California
Redlands, California, 92374
Austin Retina Associates, PLLC (Round Rock)
Round Rock, Texas, 78681
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825
Retina Consultants of Texas (San Antonio)
San Antonio, Texas, 78240
Spokane Eye Clinical Research
Spokane, Washington, 99204
Springfield Clinic LLP
Springfield, Illinois, 62703
Cascade Medical Research Institute
Springfield, Oregon, 97477
Retina Consultants of Texas (Woodlands)
The Woodlands, Texas, 77384
Retina Associates SW
Tucson, Arizona, 85704
North Carolina Retina Associates (Wake Forest)
Wake Forest, North Carolina, 27587
Retina Group of New England, PC
Waterford, Connecticut, 06385
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
Puerto Rico1 site
Emanuelli Research & Development Center, LLC
Arecibo, 00612
About this study
Official title: A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants With Diabetic Retinopathy (DR) - GLOW2
This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.
Read the detailed description
This is a prospective, randomized, double-masked, two-arm, multi-center Phase 3 study to demonstrate that tarcocimab 5 mg is superior to sham treatment, with respect to the proportion of eyes improving from baseline at Week 48 in participants with DR.
- Conditions
- Diabetic Retinopathy
- Being tested
- Tarcocimab, Sham injection
- Keywords
- Diabetic Retinopathy, NPDR, KSI-301, VEGF, Anti-VEGF, Vascular Endothelial Growth Factor, Antibody Biopolymer Conjugate, Retinal Degeneration, Retinal Diseases, Eye Diseases, Retinopathy, Vision Disorders, Kodiak, Tarcocimab Tedromer, Tarcocimab, Diabetic Eye Disease
- Medical subject headings
- Diabetic Retinopathy, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarcocimabDrug
Also called Tarcocimab tedromer, KSI-301
Intravitreal injection
Sham injectionOther
The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
| Study group | Role | What they receive |
|---|---|---|
| Tarcocimab 5 mg (Treatment Group A) | Experimental | Tarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44. Receives: Drug: Tarcocimab |
| Treatment Group B | Sham comparator | Sham injection on the same schedule as Treatment Group A Receives: Other: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.
Measured: Day 1 to Week 48
Secondary outcomes (2)
Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy
Sight-threatening complications include diabetic macular edema, new or worsening proliferative diabetic retinopathy, and anterior segment neovascularization
Measured: Day 1 to Week 48
Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.
Measured: Day 1 to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 May 2024
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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 1:1 into one of two arms: KSI-301 or sham.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kodiak Sciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Velazquez-Martin, MD, Study director, Kodiak Sciences Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270836
- Sponsor's protocol ID
- KS301P108
- Acronym
- GLOW2
- Status last verified
- May 2026
- First submitted
- 14 Feb 2024
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants With Diabetic Retinopathy (DR) - GLOW2
- ClinicalTrials.gov ID
- NCT06270836
- Acronym / sponsor ID
- GLOW2 / KS301P108
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy, NPDR, KSI-301, VEGF, Anti-VEGF, Vascular Endothelial Growth Factor, Antibody Biopolymer Conjugate, Retinal Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Kodiak Sciences IncIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 21 Feb 2024 (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.
This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.
Detailed description
This is a prospective, randomized, double-masked, two-arm, multi-center Phase 3 study to demonstrate that tarcocimab 5 mg is superior to sham treatment, with respect to the proportion of eyes improving from baseline at Week 48 in participants with DR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 into one of two arms: KSI-301 or sham.
| Arm | Type | Receives |
|---|---|---|
| Tarcocimab 5 mg (Treatment Group A) | Experimental | Drug: TarcocimabTarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44. |
| Treatment Group B | Sham comparator | Other: Sham injectionSham injection on the same schedule as Treatment Group A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent prior to participation in the study.
- Type 1 or 2 diabetes mellitus and HbA1c of ≤12%.
- DR in the Study Eye (DRSS as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for DR or DME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
- CST ≤320 microns and a BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the Study Eye at screening and confirmed at Day 1; OR
- CST >320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79 letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye at screening and confirmed at Day 1.
Key exclusion criteria (16 listed)
- Prior PRP in the Study Eye.
- Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
- Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1.
- Prior intravitreal or periocular steroid in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1.
- Prior use of an investigational intravitreal treatment for DR or DME 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 |
|---|---|---|
| TarcocimabAlso: Tarcocimab tedromer, KSI-301Intravitreal injection | Drug | Tarcocimab 5 mg (Treatment Group A) |
| Sham injectionThe sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study. | Other | Treatment Group B |
Primary outcome
Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Time frame: Day 1 to Week 48
Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.
2 secondary outcomes
Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy
Time frame: Day 1 to Week 48
Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Time frame: Day 1 to Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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. This study is not recruiting at the moment.
Pablo Velazquez-Martin, MD study director
Kodiak Sciences Inc
39 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 Tarcocimab in people with Diabetic Retinopathy, run by Kodiak Sciences Inc at 39 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) (time frame: Day 1 to Week 48). 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 13 May 2026.