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)
Arizona Retina and Vitreous Consultants
🇺🇸Phoenix, Arizona, United States
Retina Associates Tucson
🇺🇸Tucson, Arizona, United States
Win Retina
🇺🇸Arcadia, California, United States
Global Research Management
🇺🇸Glendale, California, United States
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 Group of New England
🇺🇸Waterford, Connecticut, United States
Rand Eye
🇺🇸Deerfield Beach, Florida, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Scroll for more (58 remaining)Arizona Retina and Vitreous Consultants🇺🇸Phoenix, Arizona, United States