Special Drug Use Observational Study With Beovu Kit for I... | NCT05526729 | Trialant

Special Drug Use Observational Study With Beovu Kit for I... | NCT05526729 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Beovu	Other	Prospective observational study. There was no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema were eligible to enroll into this study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period	Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period was collected. Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion	Up to 52 weeks
Proportions of patients with adverse events in the eyes on therapy during the observation period	Proportions of patients with adverse events in the eyes on therapy during the observation period was collected	Up to 52 weeks
Proportion of patients with systemic adverse events during the observation period	Proportion of patients with systemic (non-ocular) adverse events during the observation period was collected	Up to 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period	Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period was collected	Up to 52 weeks
Proportion of patients with systemic SAEs and adverse reactions during the observation period

Contacts/Locations Module