Phase 2
N=139
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
Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT04265261 ↗Enrolled (actual)
139
Serious AEs
11.6%
Results posted
Sep 2024
Primary outcome: Primary: 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 — 7.89; 9.52; 5.71 Percentage of participants — p=0.8586
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); RG7774 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
7.89; 9.52; 5.71 | 0.8586 |
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
72.3; 64.6; 81.4 | — |
| SECONDARY Time-to-Event for Vision-Threatening DR in the Study Eye |
NA; 267.0; NA | — |
| SECONDARY 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 |
0; 0; 0; 0; 6.3; 0 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36 |
0.12; -0.45; -0.22 | — |
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.
Eligibility Criteria
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) 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
Data sourced from ClinicalTrials.gov (NCT04265261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.