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

Phase 2 Completed 139 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2020-06-05
Primary completion: 2023-07-19
Completion: 2023-07-19

Outcome

Missed primary endpoint

paper The primary efficacy endpoint was not met: PMID 39802207 ↗

registry p = 0.8586; Risk Difference (RD) 1.19 (95% CI -11.86 to 14.23) NCT04265261 ↗

registry p = 0.6388; Risk Difference (RD) -2.93 (95% CI -15.18 to 9.31) NCT04265261 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	vicasinabin	Small molecule	30 mg	Oral
Subject	vicasinabin	Small molecule	200 mg	Oral