Non-proliferative Diabetic Retinopathy Clinical Trial
— GLOW2Official 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 Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR) - GLOW2
This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent prior to participation in the study. - Type 1 or 2 diabetes mellitus and HbA1c of =12%. - Moderately severe to severe NPDR in the Study Eye (DRSS levels 47 and 53 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. Exclusion Criteria: - 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. - Prior intravitreal or periocular steroid in the Study Eye for DR or DME. - 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. |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Emanuelli Research & Development Center, LLC | Arecibo | |
United States | Retina Research Institute of Texas | Abilene | Texas |
United States | Panhandle Eye Group, LLP. - Southwest Retina Specialists | Amarillo | Texas |
United States | Southeast Retina Center | Augusta | Georgia |
United States | Austin Retina Associates, PLLC (Austin) | Austin | Texas |
United States | Retina Consultants of Texas (Bellaire) | Bellaire | Texas |
United States | Mid Atlantic Retina | Bethlehem | Pennsylvania |
United States | Envision Ocular, LLC | Bloomfield | New Jersey |
United States | Star Vision Research | Burleson | Texas |
United States | Associated Vitreoretinal and Uveitis Consultants | Carmel | Indiana |
United States | Blue Ocean Clinical Research | Clearwater | Florida |
United States | Retina Group of Florida | Fort Lauderdale | Florida |
United States | Retina Consultants of Orange County | Fullerton | California |
United States | Global Research Management, Inc. - Lugene Eye Institute | Glendale | California |
United States | Cumberland Valley Retina Consultants | Hagerstown | Maryland |
United States | Retina Consultants of Texas (Katy) | Katy | Texas |
United States | Southeastern Retina Associates PC | Knoxville | Tennessee |
United States | Piedmont Eye Center | Lynchburg | Virginia |
United States | Florida Eye Associates | Melbourne | Florida |
United States | Retinal Consultants Medical Group, Inc. | Modesto | California |
United States | Northern California Retina Vitreous Associates | Mountain View | California |
United States | Texas Retina Associates | Plano | Texas |
United States | Retina Consultants of Southern California | Redlands | California |
United States | Austin Retina Associates, PLLC (Round Rock) | Round Rock | Texas |
United States | Retinal Consultants Medical Group, Inc. | Sacramento | California |
United States | Retina Consultants of Texas (San Antonio) | San Antonio | Texas |
United States | Cascade Medical Research Institute | Springfield | Oregon |
United States | Springfield Clinic LLP | Springfield | Illinois |
United States | Retina Consultants of Texas (Woodlands) | The Woodlands | Texas |
United States | Retina Group of New England, PC | Waterford | Connecticut |
United States | Strategic Clinical Research Group, LLC | Willow Park | Texas |
United States | Center for Retina and Macular Disease | Winter Haven | Florida |
Lead Sponsor | Collaborator |
---|---|
Kodiak Sciences Inc |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 1 to Week 48 | |
Secondary | Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy | Sight-threatening complications include diabetic macular edema, proliferative diabetic retinopathy and anterior segment neovascularization | Day 1 to Week 48 | |
Secondary | 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. | Day 1 to Week 48 |
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