Trials / Active Not Recruiting
Active Not RecruitingNCT06548568
A Real-world Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Adult Participants With Diabetic Macular Edema in China
A Two-year Non-interventional, Real-world, Observational Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Patients With Diabetic Macular Edema in China
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 110 (estimated)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The dexamethasone intravitreal implant (OZURDEX) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of diabetic macular edema (DME). This study will assess the long-term safety and effectiveness of OZURDEX in adult participants with DME in the routine clinical setting in China. Approximately 110 participants who are prescribed OZURDEX by their physicians will be enrolled in multiple medical institutions in China where OZURDEX is used for DME in routine clinical practice. Participants will be followed for 24 months after the first administration of OZURDEX according to the routine clinical practice of the prescribing centers. A subsequent 30-day follow-up after the last dose will be performed to obtain information on any new or ongoing safety events and concomitant medications. No additional burden for participants in this trial is expected.
Conditions
Timeline
- Start date
- 2024-11-13
- Primary completion
- 2027-04-01
- Completion
- 2027-04-01
- First posted
- 2024-08-12
- Last updated
- 2025-09-19
Locations
13 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06548568. Inclusion in this directory is not an endorsement.