Assessing the safety of OZURDEX for diabetic macular edema in adults 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

This study is testing the long-term safety of a treatment called OZURDEX for adults with diabetic macular edema in China to see how well it works in real life.

Quick facts

• Study type: Observational
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Locations: 7 sites (Xiamen, Fujian and 6 other locations)
• Trial ID: NCT06548568 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the long-term safety and effectiveness of the dexamethasone intravitreal implant (OZURDEX) in adult patients diagnosed with diabetic macular edema (DME) in a real-world clinical setting in China. Approximately 110 participants who are scheduled to receive OZURDEX will be enrolled across multiple medical institutions. Participants will be monitored for 24 months following their first injection, with an additional 30-day follow-up to assess any ongoing safety concerns or adverse events. The study aims to gather data without imposing additional burdens on participants.

Who should consider this trial

Good fit: Ideal candidates for this study are adults scheduled to receive at least one intravitreal OZURDEX injection for diabetic macular edema.

Not a fit: Patients with contraindications to OZURDEX or those participating in other interventional clinical research may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety profile of OZURDEX for treating diabetic macular edema.

How similar studies have performed: Other studies have shown positive outcomes with similar approaches in assessing the safety and effectiveness of OZURDEX for diabetic macular edema.

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.

Where this trial is running

Xiamen, Fujian and 6 other locations

• Xiamen Eye Center of Xiamen University /ID# 268172 — Xiamen, Fujian, China (Recruiting)
• Henan Provincial Eye Hosptial /ID# 272424 — Zhengzhou, Henan, China (Recruiting)
• Xi'an Fourth Hospital /ID# 270562 — Xian, Shaanxi, China (Recruiting)
• Qingdao Eye Hospital Of Shandong First Medical University /ID# 268173 — Qingdao, Shandong, China (Recruiting)
• Shanghai General hospital /ID# 270376 — Shanghai, Shanghai, China (Recruiting)
• West China Hospital of Sichuan University /ID# 273656 — Chengdu, Sichuan, China (Recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 273617 — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: AbbVie China Evidence Solutions

Conditions Diabetic Macular Edema; OZURDEX