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
- Registration Number
- NCT04265261
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The study's main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C RG7774 Participants will receive a high oral dose of RG7774 QD Group A Placebo Participants will receive an oral dose of placebo matched to RG7774 once daily (QD) Group B RG7774 Participants will receive a low oral dose of RG7774 QD
- Primary Outcome Measures
Name Time Method 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 Week 36 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)
Percentage of Participants With Adverse Events (AEs) Up to 1 year (baseline through follow-up period)
- Secondary Outcome Measures
Name Time Method Time-to-Event for Vision-Threatening DR in the Study Eye Up to Day 277 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.
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 Week 36 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.
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36 Baseline; 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.
Trial Locations
- Locations (68)
Rand Eye
🇺🇸Deerfield Beach, Florida, United States
Retina Associates Tucson
🇺🇸Tucson, Arizona, United States
University of Michigan, Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
EyeHealth Northwest
🇺🇸Portland, Oregon, United States
Win Retina
🇺🇸Arcadia, California, United States
Charlotte Eye Ear Nose and Throat Associates
🇺🇸Charlotte, North Carolina, United States
Global Research Management
🇺🇸Glendale, California, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Austin Clinical Research LLC
🇺🇸Austin, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Sydney Eye Hospital
🇦🇺Sydney, New South Wales, Australia
Marietta Eye Clinic
🇺🇸Marietta, Georgia, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Velocity Clinical Research
🇺🇸East Syracuse, New York, United States
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Cumberland Valley Retina PC
🇺🇸Hagerstown, Maryland, United States
Centrum Medyczne UNO-MED
🇵🇱Krakow, Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
🇵🇱Olsztyn, Poland
Medeye Associates
🇺🇸Miami, Florida, United States
Arizona Retina and Vitreous Consultants
🇺🇸Phoenix, Arizona, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
Retina Vitreous Assoc of FL
🇺🇸Saint Petersburg, Florida, United States
O?ná klinika UNB a SZU
🇸🇰Bratislava, Slovakia
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Retina Consultants of Southern Colorado PC
🇺🇸Colorado Springs, Colorado, United States
Retina Associated Ltd
🇺🇸Elmhurst, Illinois, United States
University Retina and Macula Associates, PC
🇺🇸Oak Forest, Illinois, United States
Deep Blue Retina PLLC
🇺🇸Southaven, Mississippi, United States
Southeastern Retina Associates Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Erie Retinal Surgery
🇺🇸Erie, Pennsylvania, United States
Retina Res Institute of Texas
🇺🇸Abilene, Texas, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Retinal Consultants of Houston
🇺🇸The Woodlands, Texas, United States
Sydney Retina Clinic and Day Surgery
🇦🇺Sydney, New South Wales, Australia
Centre For Eye Research Australia
🇦🇺East Melbourne, Victoria, Australia
Retina Specialists Victoria
🇦🇺Rowville, Victoria, Australia
Klinika Oftalmológie LFUK a UNB
🇸🇰Bratislava, Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
🇸🇰Banska Bystrica, Slovakia
Emanuelli Research and Development Center LLC
🇵🇷Arecibo, Puerto Rico
3F s.r.o
🇸🇰Košice, Slovakia
Fakultna nemocnica Trencin
🇸🇰Trencin, Slovakia
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
🇸🇰Zilina, Slovakia
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
🇪🇸Hospitalet De Llobregat, Barcelona, Spain
Hospital General de Catalunya
🇪🇸San Cugat Del Valles, Barcelona, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Dos de Maig
🇪🇸Barcelona, Spain
Hospital Clinic I Provincial
🇪🇸Barcelona, Spain
Clinica Barraquer
🇪🇸Barcelona, Spain
Miguel Servet University Hospital
🇪🇸Zaragoza, Spain
Pio del Rio Hortega University Hospital
🇪🇸Valladolid, Spain
Royal Victoria Hospital; Outpatients Department
🇬🇧Belfast, United Kingdom
Colchester General Hospital
🇬🇧Colchester, Essex, United Kingdom
Royal Surrey County Hospital; Eye Clinic Research office
🇬🇧Guilford, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Sunderland Eye Infirmary
🇬🇧Sunderland, United Kingdom
Ophthalmic Consultants of Long Island
🇺🇸Oceanside, New York, United States
Centrum Medyczne Julianow; Zeglarska
🇵🇱?ód?, Poland
Gabinet Okulistyczny Prof Edward Wylegala
🇵🇱Katowice, Poland
LensClinic
🇵🇱Rybnik, Poland
Retina Group of New England
🇺🇸Waterford, Connecticut, United States
Envision Ocular, LLC
🇺🇸Bloomfield, New Jersey, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Hull University Teaching Hospitals NHS Trust
🇬🇧Hull, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom