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)

January 15, 2024 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital
      • Sydney, New South Wales, Australia, 2000
        • Sydney Retina Clinic and Day Surgery
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Centre for Eye Research Australia
      • Rowville, Victoria, Australia, 3178
        • Retina Specialists Victoria
  • Poland
      • ?ód?, Poland, 91-321
        • Centrum Medyczne Julianow; Zeglarska
      • Katowice, Poland, 40-594
        • Gabinet Okulistyczny Prof Edward Wylegala
      • Krakow, Poland, 31-070
        • Centrum Medyczne Uno-Med
      • Olsztyn, Poland, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka LENS
      • Rybnik, Poland, 44-203
        • LensClinic
  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research and Development Center LLC
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta
      • Bratislava, Slovakia, 826 06
        • Klinika Oftalmológie LFUK a UNB
      • Bratislava, Slovakia, 851 07
        • O?ná klinika UNB a SZU
      • Košice, Slovakia, 040 11
        • 3F s.r.o
      • Trencin, Slovakia, 911 71
        • Fakultna Nemocnica Trencin
      • Zilina, Slovakia, 012 07
        • Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08025
        • Hospital Dos de Maig
      • Barcelona, Spain, 8021
        • Clinica Barraquer
      • Valladolid, Spain, 47012
        • Pio del Rio Hortega University Hospital
      • Zaragoza, Spain, 50009
        • Miguel Servet University Hospital
    • Barcelona
      • Hospitalet De Llobregat, Barcelona, Spain, 8907
        • Hospital Universitari de Bellvitge; Servicio de Oftalmologia
      • San Cugat Del Valles, Barcelona, Spain, 08195
        • Hospital General de Catalunya
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital; Outpatients Department
      • Colchester, Essex, United Kingdom, CO4 5JL
        • Colchester General Hospital
      • Guilford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital; Eye Clinic Research office
      • Hull, United Kingdom, HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust
      • Sunderland, United Kingdom, SR2 9HP
        • Sunderland Eye Infirmary
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Retina and Vitreous Consultants
      • Tucson, Arizona, United States, 85710
        • Retina Associates Tucson
    • California
      • Arcadia, California, United States, 91006
        • Win Retina
      • Glendale, California, United States, 91204
        • Global Research Management
      • Torrance, California, United States, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado PC
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants
      • Melbourne, Florida, United States, 32901
        • Florida Eye Associates
      • Miami, Florida, United States, 33143
        • MedEye Associates
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Saint Petersburg, Florida, United States, 33711
        • Retina Vitreous Assoc of FL
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
      • Marietta, Georgia, United States, 30060
        • Marietta Eye Clinic
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Retina Associated Ltd
      • Oak Forest, Illinois, United States, 60452
        • University Retina and Macula Associates, PC
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina PC
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan, Kellogg Eye Center
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Deep Blue Retina PLLC
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Eye Associates of New Mexico
    • New York
      • East Syracuse, New York, United States, 13057
        • Velocity Clinical Research
      • Oceanside, New York, United States, 11572
        • Ophthalmic Consultants of Long Island
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Charlotte Eye Ear Nose and Throat Associates
    • Oregon
      • Portland, Oregon, United States, 97225
        • EyeHealth Northwest
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Erie Retinal Surgery
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Southeastern Retina Associates Chattanooga
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Res Institute of Texas
      • Austin, Texas, United States, 78750
        • Austin Clinical Research LLC
      • San Antonio, Texas, United States, 78215
        • San Antonio Eye Center
      • The Woodlands, Texas, United States, 77384-4167
        • Retina Consultants of Texas
      • The Woodlands, Texas, United States, 77384
        • Retinal Consultants of Houston
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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

Exclusion Criteria

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
  • Known hypersensitivity to any of the excipients of the drug used, fluorescein dye or dilating eye drops
  • Use of systemic medications known to be toxic to the lens, retina or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol) used during the 6-month period prior to screening or likely need to be used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group A
Participants will receive an oral dose of placebo matched to RG7774 once daily (QD)
Drug: Placebo
Participants will receive oral placebo matched to RG7774
Experimental: Group B
Participants will receive a low oral dose of RG7774 QD
Drug: RG7774
Participants will receive oral RG7774
Experimental: Group C
Participants will receive a high oral dose of RG7774 QD
Drug: RG7774
Participants will receive oral RG7774

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Week 36
Week 36
Percentage of Participants with Adverse Events (AEs)
Time Frame: From baseline up to 52 weeks
From baseline up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Anterior Segment Neovascularization (ASNV), new Proliferative Diabetic Retinopathy (PDR), new Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention
Time Frame: From baseline up to 52 weeks
From baseline up to 52 weeks
Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time Frame: Baseline; Week 36
Baseline; Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2020

Primary Completion (Actual)

July 19, 2023

Study Completion (Actual)

July 19, 2023

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP41321
  • 2019-002067-10 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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