nctId: NCT06270836 id: KS301P108 briefTitle: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR) acronym: GLOW2 overallStatus: RECRUITING date: 2024-03-27 date: 2025-12-30 date: 2025-12-30 date: 2024-02-21 date: 2024-04-08 name: Kodiak Sciences Inc class: INDUSTRY briefSummary: This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR. conditions: Non-proliferative Diabetic Retinopathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized 1:1 into one of two arms: KSI-301 or sham. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Tarcocimab name: Sham injection measure: Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) measure: Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy measure: Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Retina Consultants of Orange County status: NOT_YET_RECRUITING city: Fullerton state: California zip: 92835 country: United States lat: 33.87029 lon: -117.92534 facility: Global Research Management, Inc. - Lugene Eye Institute status: NOT_YET_RECRUITING city: Glendale state: California zip: 91204 country: United States lat: 34.14251 lon: -118.25508 facility: Northern California Retina Vitreous Associates status: NOT_YET_RECRUITING city: Mountain View state: California zip: 94040 country: United States lat: 37.38605 lon: -122.08385 facility: Retina Consultants of Southern California status: NOT_YET_RECRUITING city: Redlands state: California zip: 92374 country: United States lat: 34.05557 lon: -117.18254 facility: Blue Ocean Clinical Research status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33761 country: United States lat: 27.96585 lon: -82.8001 facility: Florida Eye Associates status: NOT_YET_RECRUITING city: Melbourne state: Florida zip: 32901 country: United States lat: 28.08363 lon: -80.60811 facility: Center for Retina and Macular Disease status: NOT_YET_RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States lat: 28.02224 lon: -81.73286 facility: Southeast Retina Center status: NOT_YET_RECRUITING city: Augusta state: Georgia zip: 30909 country: United States lat: 33.47097 lon: -81.97484 facility: Springfield Clinic LLP status: NOT_YET_RECRUITING city: Springfield state: Illinois zip: 62703 country: United States lat: 39.80172 lon: -89.64371 facility: Cumberland Valley Retina Consultants status: NOT_YET_RECRUITING city: Hagerstown state: Maryland zip: 21740 country: United States lat: 39.64176 lon: -77.71999 facility: Envision Ocular, LLC status: NOT_YET_RECRUITING city: Bloomfield state: New Jersey zip: 07003 country: United States lat: 40.80677 lon: -74.18542 facility: Cascade Medical Research Institute status: NOT_YET_RECRUITING city: Springfield state: Oregon zip: 97477 country: United States lat: 44.04624 lon: -123.02203 facility: Mid Atlantic Retina status: NOT_YET_RECRUITING city: Bethlehem state: Pennsylvania zip: 18017 country: United States lat: 40.62593 lon: -75.37046 facility: Southeastern Retina Associates PC status: NOT_YET_RECRUITING city: Knoxville state: Tennessee zip: 37922 country: United States lat: 35.96064 lon: -83.92074 facility: Retina Research Institute of Texas status: RECRUITING city: Abilene state: Texas zip: 79606 country: United States lat: 32.44874 lon: -99.73314 facility: Panhandle Eye Group, LLP. - Southwest Retina Specialists status: NOT_YET_RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Star Vision Research status: NOT_YET_RECRUITING city: Burleson state: Texas zip: 76028 country: United States lat: 32.54208 lon: -97.32085 facility: Texas Retina Associates status: NOT_YET_RECRUITING city: Plano state: Texas zip: 75075 country: United States lat: 33.01984 lon: -96.69889 facility: Strategic Clinical Research Group, LLC status: NOT_YET_RECRUITING city: Willow Park state: Texas zip: 76087 country: United States lat: 32.76263 lon: -97.65058 facility: Piedmont Eye Center status: NOT_YET_RECRUITING city: Lynchburg state: Virginia zip: 24502 country: United States lat: 37.41375 lon: -79.14225 facility: Emanuelli Research & Development Center, LLC status: NOT_YET_RECRUITING city: Arecibo zip: 00612 country: Puerto Rico lat: 18.47245 lon: -66.71573 hasResults: False