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
CANBERRA
A Randomized, Double-Masked, 48-Week, Parallel-Group, Placebo-Controlled, Proof-of-Concept Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
2 other identifiers
interventional
139
7 countries
68
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
Typical duration for phase_2
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedStudy Start
First participant enrolled
June 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2023
CompletedResults Posted
Study results publicly available
September 25, 2024
CompletedSeptember 25, 2024
August 1, 2024
3.1 years
February 5, 2020
July 16, 2024
August 30, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Time-to-Event for Vision-Threatening DR in the Study Eye
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
Week 36
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36
Baseline; Week 36
Study Arms (3)
Group A
PLACEBO COMPARATORParticipants will receive an oral dose of placebo matched to RG7774 once daily (QD)
Group B
EXPERIMENTALParticipants will receive a low oral dose of RG7774 QD
Group C
EXPERIMENTALParticipants will receive a high oral dose of RG7774 QD
Interventions
Eligibility Criteria
You may qualify if:
- Able and willing to provide written informed consent and to comply with the study protocol according to International Conference of Harmonization (ICH) and local regulations
- Male and female patients of at least 18 years of age
- Treatment naïve with moderately severe to severe NPDR defined as ETDRS DRSS 47 or 53
- Patients are eligible with and without DME in either eye
- BCVA score at screening of at least 70 letters in study eyes without DME and at least 75 letters in case DME is present
- Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images.
- Diagnosis of diabetes mellitus (DM) type 1 or type 2
- Hemoglobin A1c (HbA1c) \</= 12%.
- A female is eligible to participate if she is not pregnant, not breastfeeding
You may not qualify if:
- Ocular criteria for study eye:
- Prior treatment for DR or other retinal diseases with any approved or investigational therapy, including but not limited to intravitreal steroids, intravitreal anti-VEGF, light therapy, periocular pharmacological intervention, and laser (e.g. focal, grid, micropulse, or pan-retinal)
- Uncontrolled glaucoma
- Any concurrent intraocular condition (e.g. retinal detachment, dense cataract, epiretinal membrane with traction, or vitreomacular traction, etc.) that in the opinion of the Investigator could reduce the potential for improvement, require medical surgical intervention or may confound the visual and functional assessment and interpretation of study results
- Concurrent ocular conditions in either eye:
- Any active ocular infection
- Any active intraocular inflammation
- General Criteria:
- Previous systemic use of anti-VEGF drugs within 6 months prior to screening
- Complications of diabetes such as end-stage renal disease or liver disease
- Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to screening
- Uncontrolled blood pressure (\[BP\] defined as systolic \> 180mmHg and/or diastolic \>100 mmHg while patient at rest)
- History of concurrent cardio-vascular disease not considered well controlled by the Investigator
- Any major illness or major surgical procedure within one month before screening
- History of or currently active other diseases, metabolic dysfunction, physical examination finding, malignancies not considered cured, or clinical laboratory findings giving reasonable suspicion of a condition that contraindicated the use of the investigational medicinal drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications in the opinion of the investigator
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
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
St. 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
Banská 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
Trenčín, 911 71, Slovakia
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
Žilina, 012 07, Slovakia
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
L'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
Guildford, 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
Related Publications (1)
Armendariz BG, Luhman UFO, Berger B, Hernandez-Sanchez J, Bogman K, Mitrousis N, Wollenhaupt M, Kent D, Wenzel A, Fauser S. CANBERRA: A Phase II Randomized Clinical Trial to Test the Therapeutic Potential of Oral Vicasinabin in Diabetic Retinopathy. Ophthalmol Sci. 2024 Nov 8;5(2):100650. doi: 10.1016/j.xops.2024.100650. eCollection 2025 Mar-Apr.
PMID: 39802207DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2020
First Posted
February 11, 2020
Study Start
June 5, 2020
Primary Completion
July 19, 2023
Study Completion
July 19, 2023
Last Updated
September 25, 2024
Results First Posted
September 25, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).