Status:
ACTIVE_NOT_RECRUITING
A Real-world Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Adult Participants With Diabetic Macular Edema in China
Lead Sponsor:
AbbVie
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Brief 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 ass...
Eligibility Criteria
Inclusion
- \- Participant scheduled to receive at least one intravitreal OZURDEX® injection for DME as per most current local approved label after its approval for DME in China.
Exclusion
- Concurrent participation in interventional clinical research that required treatment or use of an investigational agent.
- Participants for whom OZURDEX® is contraindicated:
- Participants with known hypersensitivity to OZURDEX® or any components of this product.
- Participants with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Participants with late stage glaucoma that cannot be controlled with medication alone.
- Aphakia with ruptured posterior lens capsule.
- Eyes with anterior chamber intraocular lenses (ACIOL), iris- or scleral-fixated intraocular lenses, and ruptured posterior lens capsule.
Key Trial Info
Start Date :
November 13 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06548568
Start Date
November 13 2024
End Date
April 1 2027
Last Update
September 19 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University People'S Hospital /ID# 274505
Beijing, Beijing Municipality, China, 100034
2
Xiamen Eye Center of Xiamen University /ID# 268172
Xiamen, Fujian, China, 390000
3
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 274555
Guangzhou, Guangdong, China, 510623
4
Henan Provincial Eye Hosptial /ID# 272424
Zhengzhou, Henan, China, 450003