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

AbbVie

Status: Enrolling

Conditions: Diabetic Macular Edema

Study type: Observational

Funder types: Industry

Identifiers

NCT06548568

P24-425

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

110 participants in 1 patient group

OZURDEX

Description:

Participants with diabetic macular edema prescribed OZURDEX in routine clinical practice are observed from the first dose for up to 24 months.