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)

August 30, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
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
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)
Time Frame: Up to 1 year (baseline through follow-up period)
Up to 1 year (baseline through follow-up period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-to-Event for Vision-Threatening DR in the Study Eye
Time Frame: 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.
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
Time Frame: 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.
Week 36
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36
Time Frame: 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.
Baseline; Week 36

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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