Diabetic retinopathy MedDRA version: 20.1 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: RG7774
Product Code: RG7774/F08
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RG7774
Current Sponsor code: RG7774
Other descriptive name: RO6868847
Concentration unit: mg
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age >= 18 years Ocular Criteria for study eye: • Treatment naïve with moderately severe to severe Non-proliferative DR (NPDR) defined as Early Treatment Diabetic Retinopathy Study (ETDRS) DR severity score (DRSS) 47 or 53 • Patients are eligible with and without Diabetic Macular Edema (DME) in either eye, defined as the presence of signs in the macula such as swelling, leakage, exudates, cystoid changes and fluid. In addition, Central Subfield Thickness (CST) on SD OCT needs to be ? 300µm to confirm diagnosis of DME • If present, DME has to be treatment-naïve and not expected to require treatment during the duration of the study in the opinion of the investigator at screening and Day 1 • Best corrected visual acuity (BCVA) score at screening of at least 70 letters in study eyes without DME and at least 75 letters in case DME is present, using ETDRS visual acuity testing charts at a testing distance of 4 meters • Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images General Criteria: • Diagnosis of diabetic retinopathy type 1 or type 2, as defined by the World Health Organization and/or American Diabetes Association • HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Ocular criteria for Study eye: • Prior treatment of the retina with laser or any intravitreal anti- Vascular endothelial growth factor (VEGF) or steroid. Focal laser in the retinal periphery due to other reasons than DR at least 3 months prior to screening is permitted. • Prior periocular pharmacological intervention for other retinal diseases within 6 months prior to screening. • Intraocular surgery less than 3 months prior to screening • Aphakia or anterior chamber lens • History of vitreoretinal surgery • Uncontrolled glaucoma • Amblyopia • Any history of idiopathic or immune-mediated uveitis in either eye • Any concurrent intraocular condition 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. • 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). If the BP is controlled by antihypertensive medication, the patient should be taking the same medication continuously for at least 30 days prior to screening. • Confirmed clinically significant abnormality on ECG at screening. That includes but is not limited to QTcF > 450 ms for male participants and QTcF > 470 ms for female participants, absence of dominating sinus rhythm, AV-block II or III. • History of coagulopathies, bleeding disorders or blood dyscrasias • History of concurrent cardio-vascular disease not considered well controlled by the investigator • Risk of suicidal behavior in the opinion of the Investigator or as evidenced by a “yes” to questions 4 and/or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) taken at screening, or any suicide attempt in the last 5 years • Positive serology results for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV-1, HIV-2 • Any major illness or major surgical procedure within one month before screening. • History of or currently active other diseases, metabolic dysfunction, physical examination finding, and 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 • Alcohol and/or substance abuse/dependence during the last 12 months • Use of cannabinoids within 3 months prior to screening. One rescreening for this criterion is permitted • Use of prohibited medications within 2 weeks prior to screening, or 5 half-lives (whichever is longer) • Use of systemic medications known to be toxic to the lens, retina or optic nerve used during the 6-month period prior to screening or likely need to be used. • Participation in an investigational drug or device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Assess the effect of RG7774 on the severity of diabetic retinopathy • Evaluate the safety and tolerability of RG7774;Secondary Objective: • Assess the effect of RG7774 on progression to vision-threatening DR • Assess the effect of RG7774 on visual acuity ;Primary end point(s): 1. Proportion of participants with >= 2 step improvement in the Early Treatment Diabetic Retinopathy Study DR severity score from baseline at Week 36 measured in the study eye 2. Frequency and severity of adverse events ;Timepoint(s) of evaluation of this end point: 1. Baseline (Day 1) to Week 36 2. Up to 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of anterior segment neovascularization, new proliferative diabetic retinopathy (PDR), new DME, and pre-existing DME requiring intervention 2. Change from baseline in best corrected visual acuity at Week 36 in the study eye ;Timepoint(s) of evaluation of this end point: 1. Up to 52 weeks 2. Baseline to Week 36 | — |
Countries
Portugal, Slovakia, Spain, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed