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Clinical Trial Details

Trial ID: L6493
Source ID: NCT04265261
Associated Drug: Placebo
Title: A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
Acronym: CANBERRA
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04265261/results
Conditions: Diabetic Retinopathy
Interventions: DRUG: Placebo|DRUG: RG7774
Outcome Measures: Primary: Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye, The ETDRS DRSS is a standardized grading test to measure diabetic retinopathy progression, where higher scores indicate a higher risk of vision loss. The DRSS ranges from level 10 (no diabetic retinopathy) to level 85 (advanced diabetic retinopathy), Week 36|Percentage of Participants With Adverse Events (AEs), Up to 1 year (baseline through follow-up period) | Secondary: Time-to-Event for Vision-Threatening DR in the Study Eye, Vision-threatening DR was defined as anterior segment neovascularization (ASNV), new proliferative diabetic retinopathy (PDR), new diabetic macular edema (DME), and pre-existing DME requiring treatment. Time-to-event was defined as the time where 50% of the population develops a DR vision-threatening event., Up to Day 277|Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye, This is a descriptive summary of the incidence of new ASNV, new PDR, new DME, and pre-existing DME, all of which indicate disease progression. Each row presents the proportion of participants amongst the overall population for each event., Week 36|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36, BCVA was measured by a qualified VA examiner prior to pupil dilation using modified ETDRS Charts 1, 2, and R. The adjusted mean is reported for each group., Baseline; Week 36
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 139
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-06-05
Completion Date: 2023-07-19
Results First Posted: 2024-09-25
Last Update Posted: 2024-09-25
Locations: Arizona Retina and Vitreous Consultants, Phoenix, Arizona, 85016, United States|Retina Associates Tucson, Tucson, Arizona, 85710, United States|Win Retina, Arcadia, California, 91006, United States|Global Research Management, Glendale, California, 91204, United States|Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, 90502, United States|Retina Consultants of Southern Colorado PC, Colorado Springs, Colorado, 80909, United States|Retina Group of New England, Waterford, Connecticut, 06385, United States|Rand Eye, Deerfield Beach, Florida, 33064, United States|Florida Retina Consultants, Lakeland, Florida, 33805, United States|Florida Eye Associates, Melbourne, Florida, 32901, United States|Medeye Associates, Miami, Florida, 33143, United States|Retina Specialty Institute, Pensacola, Florida, 32503, United States|Retina Vitreous Assoc of FL, Saint Petersburg, Florida, 33711, United States|Southeast Retina Center, Augusta, Georgia, 30909, United States|Marietta Eye Clinic, Marietta, Georgia, 30060, United States|Retina Associated Ltd, Elmhurst, Illinois, 60126, United States|University Retina and Macula Associates, PC, Oak Forest, Illinois, 60452, United States|Cumberland Valley Retina PC, Hagerstown, Maryland, 21740, United States|University of Michigan, Kellogg Eye Center, Ann Arbor, Michigan, 48105, United States|Deep Blue Retina PLLC, Southaven, Mississippi, 38671, United States|Sierra Eye Associates, Reno, Nevada, 89502, United States|Envision Ocular, LLC, Bloomfield, New Jersey, 07003, United States|Eye Associates of New Mexico, Albuquerque, New Mexico, 87109, United States|Velocity Clinical Research, East Syracuse, New York, 13057, United States|Ophthalmic Consultants of Long Island, Oceanside, New York, 11572, United States|Charlotte Eye Ear Nose and Throat Associates, Charlotte, North Carolina, 28210, United States|EyeHealth Northwest, Portland, Oregon, 97225, United States|Erie Retinal Surgery, Erie, Pennsylvania, 16507, United States|Charleston Neuroscience Institute, Ladson, South Carolina, 29456, United States|Southeastern Retina Associates Chattanooga, Chattanooga, Tennessee, 37421, United States|Charles Retina Institute, Germantown, Tennessee, 38138, United States|Retina Res Institute of Texas, Abilene, Texas, 79606, United States|Austin Clinical Research LLC, Austin, Texas, 78750, United States|San Antonio Eye Center, San Antonio, Texas, 78215, United States|Retina Consultants of Texas, The Woodlands, Texas, 77384-4167, United States|Retinal Consultants of Houston, The Woodlands, Texas, 77384, United States|Strategic Clinical Research Group, LLC, Willow Park, Texas, 76087, United States|Sydney Eye Hospital, Sydney, New South Wales, 2000, Australia|Sydney Retina Clinic and Day Surgery, Sydney, New South Wales, 2000, Australia|Centre For Eye Research Australia, East Melbourne, Victoria, 3002, Australia|Retina Specialists Victoria, Rowville, Victoria, 3178, Australia|Centrum Medyczne Julianow; Zeglarska, ?ód?, 91-321, Poland|Gabinet Okulistyczny Prof Edward Wylegala, Katowice, 40-594, Poland|Centrum Medyczne UNO-MED, Krakow, 31-070, Poland|Centrum Diagnostyki i Mikrochirurgii Oka LENS, Olsztyn, 10-424, Poland|LensClinic, Rybnik, 44-203, Poland|Emanuelli Research and Development Center LLC, Arecibo, 00612, Puerto Rico|Fakultna nemocnica s poliklinikou F.D. Roosevelta, Banska Bystrica, 974 01, Slovakia|Klinika Oftalmológie LFUK a UNB, Bratislava, 826 06, Slovakia|O?ná klinika UNB a SZU, Bratislava, 851 07, Slovakia|3F s.r.o, Košice, 040 11, Slovakia|Fakultna nemocnica Trencin, Trencin, 911 71, Slovakia|Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie, Zilina, 012 07, Slovakia|Hospital Universitari de Bellvitge; Servicio de Oftalmologia, Hospitalet De Llobregat, Barcelona, 8907, Spain|Hospital General de Catalunya, San Cugat Del Valles, Barcelona, 08195, Spain|Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, 28222, Spain|Hospital Dos de Maig, Barcelona, 08025, Spain|Hospital Clinic I Provincial, Barcelona, 08036, Spain|Clinica Barraquer, Barcelona, 8021, Spain|Pio del Rio Hortega University Hospital, Valladolid, 47012, Spain|Miguel Servet University Hospital, Zaragoza, 50009, Spain|Royal Victoria Hospital; Outpatients Department, Belfast, BT12 6BA, United Kingdom|Colchester General Hospital, Colchester, Essex, CO4 5JL, United Kingdom|Royal Surrey County Hospital; Eye Clinic Research office, Guilford, GU2 7XX, United Kingdom|Hull University Teaching Hospitals NHS Trust, Hull, HU3 2JZ, United Kingdom|Royal Liverpool University Hospital, Liverpool, L7 8XP, United Kingdom|Nottingham University Hospitals NHS Trust, Nottingham, NG7 2UH, United Kingdom|Sunderland Eye Infirmary, Sunderland, SR2 9HP, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04265261

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress