A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type … (NCT04265261) | Clinical Trial Compass
CompletedPhase 2
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
United States139 participantsStarted 2020-06-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
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
Timeframe: Week 36
2
Percentage of Participants With Adverse Events (AEs)
Timeframe: Up to 1 year (baseline through follow-up period)