NCT06548568Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 110 (estimated)
- First submitted
- 8 Aug 2024
- Start date
- 13 Nov 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- AbbVie
- Diseases
- Diabetic eye disease
- NCT number
- NCT06548568
What you commit to
- Study type: Observational
- Planned participants: 110
- From 13 Nov 2024 to the primary completion date, Apr 2027
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in interventional clinical research that required treatment or use of an investigational agent.
Other illness
- 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.
Who the study is looking for
- \- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People'S Hospital /ID# 274505 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital of Sichuan University /ID# 273656 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Dalian Medical University /ID# 270563 Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 274555 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 273617 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Qingdao Eye Hospital Of Shandong First Medical University /ID# 268173 Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shanghai General hospital /ID# 270376 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanxi Eye Hospital /ID# 270564 Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| The Affiliated Eye Hospital Of Wenzhou Medical University /ID# 274466 Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| General Hospital of Central Theater Command /ID# 273618 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Xiamen Eye Center of Xiamen University /ID# 268172 Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Xi'an Fourth Hospital /ID# 270562 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Henan Provincial Eye Hosptial /ID# 272424 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.