Diabetes Mellitus, Diabetic Retinopathy, Macular Edema
Conditions
Brief summary
This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).
Interventions
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
DRUGTHR-317 8mg
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
DRUGSham injection
3 sham injections, approximately 1 month apart. No actual injections. No medication is used.
Sponsors
Oxurion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 years or older * Type 1 or type 2 Diabetes Mellitus * CI-DME with central subfield thickness of ≥ 320μm on Spectralis® SD-OCT or ≥ 305μm on non Spectralis SD-OCT, in the study eye * Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye * Reduced vision primarily due to DME, with BCVA ≤ 72 and ≥ 23 ETDRS letter score (≤ 20/40 and ≥ 20/320 Snellen equivalent) in the study eye * Non-proliferative diabetic retinopathy of any stage in the study eye * Written informed consent obtained from the subject prior to screening procedures
Exclusion criteria
* Concurrent disease in the study eye, other than CI-DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results * Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment * Any active ocular / intraocular infection or inflammation in either eye * Aphakic study eye * Poorly controlled Diabetes Mellitus * Uncontrolled hypertension * Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in BCVA | At Day 84 (Month 3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of systemic and ocular adverse events including serious adverse events | From Day 0 to Day 140 | — |
| Change from baseline in BCVA, by study visit | From Day 0 to Day 140 | — |
| Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit | From Screening to Day 140 | — |
| Withdrawal from repeat study treatment and reason for withdrawal | At Day 28 and at Day 56 | Number of subjects meeting withdrawal criteria from repeat study treatment |
Countries
Belgium, France, Germany, Slovakia, Spain, Switzerland, United Kingdom
Outcome results
None listed