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

Study Identifier
P24-425
CT.gov Identifier
NCT06548568
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Macular Edema
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Peking University People'S Hospital /ID# 274505
    Beijing, Beijing Municipality, China, 100034
    Status
    Not applicable
    Location
    Xiamen Eye Center of Xiamen University /ID# 268172
    Xiamen, Fujian, China, 390000
    Status
    Not applicable
    Location
    Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 274555
    Guangzhou, Guangdong, China, 510623
    Status
    Not applicable
    Location
    Henan Provincial Eye Hosptial /ID# 272424
    Zhengzhou, Henan, China, 450003
    Status
    Not applicable
    Location
    General Hospital of Central Theater Command /ID# 273618
    Wuhan, Hubei, China, 430000
    Status
    Not applicable
    Location
    The First Affiliated Hospital of Dalian Medical University /ID# 270563
    Dalian, Liaoning, China, 116000
    Status
    Not applicable
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