Clinical trial NCT06548568: A Real-world Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Adult Participants With Diabetic Macular Edema in China
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema
OZURDEX
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample: participants with diabetic macular edema (DME) who resided in China.

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs)
timeFrame: Up to approximately 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Eye Center of Xiamen University /ID# 268172
state: Fujian
city: Zhengzhou
country: China
facility: Henan Provincial Eye Hosptial /ID# 272424
state: Henan
city: Xian
country: China
facility: Xi'an Fourth Hospital /ID# 270562
state: Shaanxi
city: Qingdao
country: China
facility: Qingdao Eye Hospital Of Shandong First Medical University /ID# 268173
state: Shandong
city: Shanghai
country: China
facility: Shanghai General hospital /ID# 270376
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University /ID# 273656
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 273617
state: Zhejiang
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: