WHO ICTRP trial
A Study to Evaluate the Efficacy and Safety of KSI-301 Compared to Aflibercept…
EUCTR2021-000225-27-ES · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2021-000225-27-ES |
|---|---|
| Public title | A Study to Evaluate the Efficacy and Safety of KSI-301 Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD) |
| Scientific title | A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD) - Daylight |
| Primary sponsor | Kodiak Sciences Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| 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 | Latvia;Hungary;United States;Czechia;Poland;Slovakia;Spain |
| Conditions | Neovascular (Wet) Age-related Macular Degeneration (wAMD) 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… |
| Interventions | Product Name: KSI-301 Drug Product Product Code: KSI-301 Pharmaceutical Form: Solution for injection INN or Proposed INN: iridescimab vidros CAS Number: 2411896-53-0 Current Sponsor code: OG1953 Concentration unit: mg/ml… |
| Registration date | Jul 15, 2021 |
| Target size | 500 |
| Secondary IDs | KS301P107;136167 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: