WHO ICTRP trial

A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and…

CTIS2023-507207-66-00 · EU Clinical Trials Information System · Not Recruiting

Key facts

Trial ID CTIS2023-507207-66-00
Public title A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema
Scientific title A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema - DX221
Primary sponsor Oculis Operations S.a.r.l.
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): Yes Therapeutic use - (Phase IV): No
Countries Canada;India;United States;Korea, Republic of;Bulgaria;Czechia;France;Germany;Italy;Spain
Conditions Diabetic Macular Edema (DME) MedDRA version: 20.1Level: LLTClassification code: 10057934Term: Diabetic macular edema Class: 10015919;Therapeutic area: Phenomena and Processes [G] - Ocular Physiological Phenomena [G14]
Interventions Product Name: , Product Code:PRD9600068, Pharmaceutical Form: EYE DROPS, SUSPENSION, Other descriptive name: , Strength: , Product Name: Eye drops, suspension, ocular use, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name…
Registration date Jan 31, 2024
Target size 348
Registry page euclinicaltrials.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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