WHO ICTRP trial
A study to learn about the blood levels of aflibercept when high-dose…
CTIS2024-511665-11-00 · EU Clinical Trials Information System · Not Recruiting
Key facts
| Trial ID | CTIS2024-511665-11-00 |
|---|---|
| Public title | A study to learn about the blood levels of aflibercept when high-dose aflibercept is injected in both eyes of participants with diabetic macular edema or neovascular age-related macular degeneration |
| Scientific title | (22578) An open-label, non-randomized, multi-center, phase 4 pharmacokinetic study to evaluate the systemic exposure after bilateral intravitreal administration of high dose (8 mg) aflibercept in adults with diabetic macular edema or neovascular age-related macular degeneration - 22578 |
| Primary sponsor | Bayer AG |
| Registry | EU Clinical Trials Information System |
| 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): No Therapeutic use - (Phase IV): Yes |
| Countries | Czechia;Slovakia;Hungary |
| Conditions | Neovascular age-related macular degeneration (nAMD), Diabetic macular edema (DME) MedDRA version: 20.1Level: LLTClassification code: 10057934Term: Diabetic macular edema Class: 10015919 MedDRA version: 20.0Level: PTClassification code… |
| Interventions | Product Name: Eylea 114.3 mg/ml solution for injection, Product Code:PRD11034383, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: |
| Registration date | Apr 24, 2024 |
| Target size | 45 |
| Registry page | euclinicaltrials.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: