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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002100-25 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THR-317 4mg | Experimental | anti-PlGF recombinant monoclonal antibody, 4mg dose |
|
| THR-317 8mg | Experimental | anti-PlGF recombinant monoclonal antibody, 8mg dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PlGF recombinant monoclonal antibody, 4mg dose | Drug | 3 intravitreal injections of THR-317 4mg approximately 1 month apart |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Department | ThromboGenics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno | 625 00 | Czechia | ||||
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| Anti-PlGF recombinant monoclonal antibody, 8mg dose | Drug | 3 intravitreal injections of THR-317 8mg approximately 1 month apart |
|
| 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| Proportion of subjects withdrawn from repeat injection and reason for withdrawal | At day 30 and at day 60 |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 |
| Hradec Králové |
| 500 05 |
| Czechia |
| Prague | 100 34 | Czechia |
| Prague | 180 00 | Czechia |
| Budapest | 1083 | Hungary |
| Budapest | 1133 | Hungary |
| Debrecen | 4032 | Hungary |
| Pécs | 7621 | Hungary |
| Szeged | 6720 | Hungary |
| Bratislava | 826 06 | Slovakia |
| Bratislava | 851 07 | Slovakia |
| Trenčín | 911 71 | Slovakia |
| Žilina | 012 07 | Slovakia |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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