A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)
- Conditions
- Diabetic Retinopathy
- Interventions
- Other: Sham injection
- Registration Number
- NCT06270836
- Lead Sponsor
- Kodiak Sciences Inc
- Brief Summary
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 255
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tarcocimab 5 mg (Treatment Group A) Tarcocimab Tarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44. Treatment Group B Sham injection Sham injection on the same schedule as Treatment Group A
- Primary Outcome Measures
Name Time Method Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) 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.
- Secondary Outcome Measures
Name Time Method Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy Day 1 to Week 48 Sight-threatening complications include diabetic macular edema, new or worsening proliferative diabetic retinopathy, and anterior segment neovascularization
Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) 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.
Trial Locations
- Locations (37)
Retina Associates SW
🇺🇸Tucson, Arizona, United States
Global Research Management, Inc. - Lugene Eye Institute
🇺🇸Glendale, California, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Retinal Consultants Medical Group, Inc.
🇺🇸Sacramento, California, United States
Retina Consultants of Southern California
🇺🇸Redlands, California, United States
Retina Group of New England, PC
🇺🇸Waterford, Connecticut, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Associated Vitreoretinal and Uveitis Consultants
🇺🇸Carmel, Indiana, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Springfield Clinic LLP
🇺🇸Springfield, Illinois, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Retina Consultants of Nevada
🇺🇸Henderson, Nevada, United States
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Charleston Neuroscience Institute
🇺🇸Charleston, South Carolina, United States
Envision Ocular, LLC
🇺🇸Bloomfield, New Jersey, United States
Asheville Eye Associates
🇺🇸Asheville, North Carolina, United States
North Carolina Retina Associates (Cary)
🇺🇸Cary, North Carolina, United States
North Carolina Retina Associates (Wake Forest)
🇺🇸Wake Forest, North Carolina, United States
Cascade Medical Research Institute
🇺🇸Springfield, Oregon, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Southeastern Retina Associates PC
🇺🇸Knoxville, Tennessee, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Panhandle Eye Group, LLP. - Southwest Retina Specialists
🇺🇸Amarillo, Texas, United States
Austin Retina Associates, PLLC (Austin)
🇺🇸Austin, Texas, United States
Austin Research Center for Retina
🇺🇸Austin, Texas, United States
Retina Consultants of Texas (Bellaire)
🇺🇸Bellaire, Texas, United States
Star Vision Research
🇺🇸Burleson, Texas, United States
Retina Consultants of Texas (Katy)
🇺🇸Katy, Texas, United States
Texas Retina Associates
🇺🇸Plano, Texas, United States
Austin Retina Associates, PLLC (Round Rock)
🇺🇸Round Rock, Texas, United States
Retina Consultants of Texas (San Antonio)
🇺🇸San Antonio, Texas, United States
Retina Consultants of Texas (Woodlands)
🇺🇸The Woodlands, Texas, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Pacific Northwest Retina (Bellevue)
🇺🇸Bellevue, Washington, United States
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
Emanuelli Research & Development Center, LLC
🇵🇷Arecibo, Puerto Rico