A Real-world Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Adult Participants With Diabetic Macular Edema in China

NCT06548568 · tracked via the Priya Life Science China tracker

Sponsor

AbbVie

Phase

Observational

Started

2024-11-13

Last updated

2025-09-19

Condition(s) studied

Diabetic Macular Edema

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: \- 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 Criteria: * 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.

Primary outcome measure(s)

Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs) — Up to approximately 24 months
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.

Trial sites (13)

Facility	City	Region
Peking University People'S Hospital /ID# 274505	Beijing	Beijing Municipality
Xiamen Eye Center of Xiamen University /ID# 268172	Xiamen	Fujian
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 274555	Guangzhou	Guangdong
Henan Provincial Eye Hosptial /ID# 272424	Zhengzhou	Henan
General Hospital of Central Theater Command /ID# 273618	Wuhan	Hubei
The First Affiliated Hospital of Dalian Medical University /ID# 270563	Dalian	Liaoning
Xi'an Fourth Hospital /ID# 270562	Xi'an	Shaanxi
Qingdao Eye Hospital Of Shandong First Medical University /ID# 268173	Qingdao	Shandong
Shanghai General hospital /ID# 270376	Shanghai	Shanghai Municipality
West China Hospital of Sichuan University /ID# 273656	Chengdu	Sichuan
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 273617	Hangzhou	Zhejiang
The Affiliated Eye Hospital Of Wenzhou Medical University /ID# 274466	Wenzhou	Zhejiang
Shanxi Eye Hospital /ID# 270564	Taiyuan	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06548568 on ClinicalTrials.gov ↗ ← All trials in China