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