Diabetes Mellitus, Diabetic Macular Edema, Diabetic Retinopathy
Conditions
Brief summary
Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.
Interventions
3 intravitreal injections of THR-149 dose level 1, 1 month apart
3 intravitreal injections of THR-149 dose level 2, 1 month apart
3 intravitreal injections of THR-149 dose level 3, 1 month apart
DRUGTHR-149 0.13mg
3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
DRUGTHR-149 0.13mg + aflibercept 2mg
3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by an intravitreal injection of aflibercept 2mg
DRUGaflibercept 2mg + THR-149 0.13mg
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by an intravitreal injection of THR-149 0.13mg (selected dose level)
DRUGAflibercept 2mg
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection
Sponsors
Oxurion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Written informed consent obtained from the subject prior to screening procedures * Male or female aged 18 years or older at the time of signing the informed consent * Type 1 or type 2 diabetes * BCVA ETDRS letter score ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B) * Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye * Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME * BCVA ETDRS letter score ≥ 34 in the fellow eye Key
Exclusion criteria
* Macular edema due to causes other than DME in the study eye * Concurrent disease in the study eye, other than central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results * Any condition that could confound the ability to detect the efficacy of the investigational medicinal product * Previous confounding medications / interventions, or their planned administration * Presence of neovascularisation at the disc in the study eye * Presence of iris neovascularisation in the study eye * Uncontrolled glaucoma in the study eye * Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye * Untreated Diabetes Mellitus * Glycated haemoglobin A (HbA1c) \> 12% * Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study | At Month 3 |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in BCVA ETDRS letter score from Baseline, by study visit | Up to Month 6 |
| Mean change in central subfield thickness (CST) from Baseline, by study visit | Up to Month 6 |
| Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs) | Up to Month 6 |
Countries
Czechia, France, Germany, Italy, Slovakia, Spain, United Kingdom, United States
Outcome results
None listed