Diabetic Retinopathy, Macular Edema
Conditions
Brief summary
This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).
Interventions
DRUGAnti-PlGF recombinant monoclonal antibody, 4mg dose
3 intravitreal injections of THR-317 4mg approximately 1 month apart
DRUGAnti-PlGF recombinant monoclonal antibody, 8mg dose
3 intravitreal injections of THR-317 8mg approximately 1 month apart
Sponsors
ThromboGenics
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 * Centre-involved DME with CST ≥ 340µm on Spectralis SD-OCT or ≥ 320µm on non-Spectralis SD OCT, in the study eye * Reduced vision primarily due to DME, with BCVA between 72 and 23 ETDRS letters read at 4 meters (20/40 and 20/320 Snellen equivalent) in the study eye * Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye * Non-proliferative diabetic retinopathy, or stable proliferative diabetic retinopathy without neovacularisation at the disc * Written informed consent obtained from the subject prior to screening procedures
Exclusion criteria
* Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results * Previous treatments / procedures in the study eyes as follows, or their planned use during the THR-317 treatment period for up to 30 days after the last injection: panretinal or focal / grid laser photocoagulation \[3 months\], anti-VEGF treatment \[any time for anti-VEGF naïve subjects; 4 weeks for subjects with a poor response to anti-VEGF treatment\], intra-ocular or peri-ocular corticosteroids \[4 months\], steroid implant \[any time\], intra-ocular surgery \[3 months\], vitrectomy \[any time\] * Any active ocular / intra-ocular infection or inflammation in either eye * Aphakic study eye * Untreated diabetes * Glycated haemoglobin A (HbA1c) \> 12% * Uncontrolled hypertension in the opinion of the Investigator * 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 suggesting lens / zonular instability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute (up to the 7-day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject | up to the 7-day follow-up visit after each injection |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject | up to the 30-day follow-up visit after each injection |
| Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150 | From day 0 to day 150 |
| Proportion of subjects withdrawn from repeat injection and reason for withdrawal | At day 30 and at day 60 |
| Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit | Up to day 150 |
| Proportion of subjects with an acute loss (up to the 7-day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after each injection | Up to 7-day follow-up visit after each injection |
| Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit | Up to day 150 |
| Mean change from baseline in BCVA, by study visit | Up to day 150 |
| Mean change from baseline in CST, by study visit, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre (CRC) | Up to day 150 |
Countries
Czechia, Hungary, Slovakia
Outcome results
None listed