WHO ICTRP trial
A clinical study of OPT-302 with aflibercept compared to aflibercept alone in…
EUCTR2020-004694-46-SK · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-004694-46-SK |
|---|---|
| Public title | A clinical study of OPT-302 with aflibercept compared to aflibercept alone in patients with neovascular age-related macular degeneration |
| Scientific title | A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD) - COAST |
| Primary sponsor | Opthea Limited |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Puerto Rico;Malaysia;Denmark;Australia;Latvia;Netherlands;Korea, Republic… |
| Conditions | Neovascular Age-related Macular Degeneration (wet AMD) MedDRA version: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10071129… |
| Interventions | Product Name: OPT-302 Product Code: OPT-302 Pharmaceutical Form: Solution for injection INN or Proposed INN: Vascular endothelial growth factor receptor-3 (VEGFR-3) derivative fused to a human immunoglobulin (IgG)1 Fc fragment (no proposed… |
| Registration date | Sep 6, 2021 |
| Target size | 990 |
| Secondary IDs | OPT-302-1005 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: