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
1 other identifier
observational
110
1 country
13
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2024
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 12, 2024
CompletedStudy Start
First participant enrolled
November 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
September 19, 2025
September 1, 2025
2.4 years
August 8, 2024
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The AESIs can include the following: cataracts, elevated IOP and conjunctival hemorrhage.
Up to approximately 24 months
Study Arms (1)
OZURDEX
Participants with diabetic macular edema prescribed OZURDEX in routine clinical practice are observed from the first dose for up to 24 months.
Eligibility Criteria
Community sample: participants with diabetic macular edema (DME) who resided in China.
You may qualify if:
- \- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (13)
Peking University People'S Hospital /ID# 274505
Beijing, Beijing Municipality, 100034, China
Xiamen Eye Center of Xiamen University /ID# 268172
Xiamen, Fujian, 390000, China
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 274555
Guangzhou, Guangdong, 510623, China
Henan Provincial Eye Hosptial /ID# 272424
Zhengzhou, Henan, 450003, China
General Hospital of Central Theater Command /ID# 273618
Wuhan, Hubei, 430000, China
The First Affiliated Hospital of Dalian Medical University /ID# 270563
Dalian, Liaoning, 116000, China
Xi'an Fourth Hospital /ID# 270562
Xi'an, Shaanxi, 710004, China
Qingdao Eye Hospital Of Shandong First Medical University /ID# 268173
Qingdao, Shandong, 266071, China
Shanghai General hospital /ID# 270376
Shanghai, Shanghai Municipality, 200080, China
West China Hospital of Sichuan University /ID# 273656
Chengdu, Sichuan, 610041, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 273617
Hangzhou, Zhejiang, 310009, China
The Affiliated Eye Hospital Of Wenzhou Medical University /ID# 274466
Wenzhou, Zhejiang, 325027, China
Shanxi Eye Hospital /ID# 270564
Taiyuan, 030072, China
Related Links
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2024
First Posted
August 12, 2024
Study Start
November 13, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
September 19, 2025
Record last verified: 2025-09