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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 Trial)

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 277

Summary

This trial is testing a pill called RG7774 to see if it can help people with a specific stage of diabetic eye disease who still have good vision. The goal is to find out if the pill can improve or stabilize their eye condition.

Eligible Conditions
  • Diabetic Retinopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 277
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 277 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Secondary study objectives
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36
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-to-Event for Vision-Threatening DR in the Study Eye

Side effects data

From 2023 Phase 2 trial • 139 Patients • NCT04265261
14%
Diabetic retinal oedema
12%
COVID-19
5%
Vitreous haemorrhage
5%
Headache
2%
Osteomyelitis
2%
Coronary artery disease
2%
Retinal tear
2%
Pancreatitis
2%
Type 2 diabetes mellitus
2%
Anaphylactic reaction
2%
Extradural abscess
2%
Diabetic retinopathy
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vicasinabin 200 mg QD
Placebo
Vicasinabin 30 mg QD

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group CExperimental Treatment1 Intervention
Participants will receive a high oral dose of RG7774 QD
Group II: Group BExperimental Treatment1 Intervention
Participants will receive a low oral dose of RG7774 QD
Group III: Group APlacebo Group1 Intervention
Participants will receive an oral dose of placebo matched to RG7774 once daily (QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RG7774
2020
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,459 Previous Clinical Trials
1,098,086 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
174 Patients Enrolled for Diabetic Retinopathy
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
896,106 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
174 Patients Enrolled for Diabetic Retinopathy
~25 spots leftby Dec 2025
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