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Diabetic RetinopathyPhase 2CANBERRANCT04265261

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

A Phase 2 study testing RG7774 in people with Diabetic Retinopathy, run by Hoffmann-La Roche at 68 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy
What is being tested?
RG7774
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
139 participants
Where
68 sitesin 7 countries
Study dates
5 Jun 2020to 19 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

68 sites in 7 countries.

68 sites in 7 countries

United States37 sites

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan, 48105

  • Win Retina

    Arcadia, California, 91006

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003

  • Charlotte Eye Ear Nose and Throat Associates

    Charlotte, North Carolina, 28210

  • Southeastern Retina Associates Chattanooga

    Chattanooga, Tennessee, 37421

  • Retina Consultants of Southern Colorado PC

    Colorado Springs, Colorado, 80909

  • Rand Eye

    Deerfield Beach, Florida, 33064

  • Velocity Clinical Research

    East Syracuse, New York, 13057

  • Retina Associated Ltd

    Elmhurst, Illinois, 60126

  • Erie Retinal Surgery

    Erie, Pennsylvania, 16507

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Global Research Management

    Glendale, California, 91204

  • Cumberland Valley Retina PC

    Hagerstown, Maryland, 21740

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Marietta Eye Clinic

    Marietta, Georgia, 30060

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Medeye Associates

    Miami, Florida, 33143

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85016

  • EyeHealth Northwest

    Portland, Oregon, 97225

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • San Antonio Eye Center

    San Antonio, Texas, 78215

  • Deep Blue Retina PLLC

    Southaven, Mississippi, 38671

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384-4167

  • Retinal Consultants of Houston

    The Woodlands, Texas, 77384

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Retina Associates Tucson

    Tucson, Arizona, 85710

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

Other trials in United States

Spain8 sites

  • Hospital Dos de Maig

    Barcelona, 08025

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Clinica Barraquer

    Barcelona, 8021

  • Hospital Universitari de Bellvitge; Servicio de Oftalmologia

    L'Hospitalet de Llobregat, Barcelona, 8907

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital General de Catalunya

    San Cugat Del Valles, Barcelona, 08195

  • Pio del Rio Hortega University Hospital

    Valladolid, 47012

  • Miguel Servet University Hospital

    Zaragoza, 50009

Other trials in Spain

United Kingdom7 sites

  • Royal Victoria Hospital; Outpatients Department

    Belfast, BT12 6BA

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL

  • Royal Surrey County Hospital; Eye Clinic Research office

    Guildford, GU2 7XX

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP

Other trials in United Kingdom

Slovakia6 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta

    Banská Bystrica, 974 01

  • Klinika Oftalmológie LFUK a UNB

    Bratislava, 826 06

  • O?ná klinika UNB a SZU

    Bratislava, 851 07

  • 3F s.r.o

    Košice, 040 11

  • Fakultna nemocnica Trencin

    Trenčín, 911 71

  • Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

    Žilina, 012 07

Other trials in Slovakia

Poland5 sites

  • Centrum Medyczne Julianow; Zeglarska

    ?ód?, 91-321

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594

  • Centrum Medyczne UNO-MED

    Krakow, 31-070

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10-424

  • LensClinic

    Rybnik, 44-203

Other trials in Poland

Australia4 sites

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002

  • Retina Specialists Victoria

    Rowville, Victoria, 3178

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000

Other trials in Australia

Puerto Rico1 site

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Placebo, RG7774
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Participants will receive oral placebo matched to RG7774

  • RG7774Drug

    Participants will receive oral RG7774

Study groups in NCT04265261
Study groupRoleWhat they receive
Group APlacebo comparatorParticipants will receive an oral dose of placebo matched to RG7774 once daily (QD)
Receives: Drug: Placebo
Group BExperimentalParticipants will receive a low oral dose of RG7774 QD
Receives: Drug: RG7774
Group CExperimentalParticipants will receive a high oral dose of RG7774 QD
Receives: Drug: RG7774

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Week 36

  2. Percentage of Participants With Adverse Events (AEs)

    Measured: Up to 1 year (baseline through follow-up period)

Secondary outcomes (3)

  1. Time-to-Event for Vision-Threatening DR in the Study Eye

    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.

    Measured: Up to Day 277

  2. 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

    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.

    Measured: Week 36

  3. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at 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.

    Measured: Baseline; Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start5 Jun 2020
  3. Primary completion19 Jul 2023
  4. Study completion19 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04265261
Sponsor's protocol ID
BP41321
Other IDs
2019-002067-10, 2019
Acronym
CANBERRA
Status last verified
Aug 2024
First submitted
5 Feb 2020
Last updated
25 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 39802207

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RG7774 in people with Diabetic Retinopathy, run by Hoffmann-La Roche at 68 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Spain, United Kingdom, Slovakia, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04265261, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.

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