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)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    135
  • sponsor
    Hoffmann-La Roche
Updated on 11 July 2022
diabetes
type 2 diabetes mellitus
hemoglobin a1c
glycosylated hemoglobin
retinopathy
diabetic retinopathy
pupil dilation
proliferative diabetic retinopathy
background diabetic retinopathy
severe nonproliferative diabetic retinopathy

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.

Details
Condition Diabetic Retinopathy
Treatment Placebo, RG7774
Clinical Study IdentifierNCT04265261
SponsorHoffmann-La Roche
Last Modified on11 July 2022

Eligibility

Yes No Not Sure

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)
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
Uncontrolled glaucoma
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
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