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Real-World study checks OZURDEX safety in chinese DME patients

NCT ID NCT06548568

Knowledge-focused Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 110 adults with diabetic macular edema who are prescribed OZURDEX (a dexamethasone implant placed in the eye) by their doctors in routine Chinese clinics. Researchers will track side effects like cataracts, high eye pressure, and bleeding over two years. The goal is to see how safe the drug is in real-world use, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexamethasone intravitreal implant (OZURDEX)
What this could lead to
If successful, this study will confirm that OZURDEX is safe for long-term use in Chinese patients with diabetic macular edema in everyday practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It only tracks safety, not whether the drug works better than alternatives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Community sample: participants with diabetic macular edema (DME) who resided in China.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • General Hospital of Central Theater Command /ID# 273618

    Wuhan, Hubei, 430000, China

  • Henan Provincial Eye Hosptial /ID# 272424

    Zhengzhou, Henan, 450003, China

  • Peking University People'S Hospital /ID# 274505

    Beijing, Beijing Municipality, 100034, China

  • Qingdao Eye Hospital Of Shandong First Medical University /ID# 268173

    Qingdao, Shandong, 266071, China

  • Shanghai General hospital /ID# 270376

    Shanghai, Shanghai Municipality, 200080, China

  • Shanxi Eye Hospital /ID# 270564

    Taiyuan, 030072, China

  • The Affiliated Eye Hospital Of Wenzhou Medical University /ID# 274466

    Wenzhou, Zhejiang, 325027, China

  • The First Affiliated Hospital of Dalian Medical University /ID# 270563

    Dalian, Liaoning, 116000, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 273617

    Hangzhou, Zhejiang, 310009, China

  • West China Hospital of Sichuan University /ID# 273656

    Chengdu, Sichuan, 610041, China

  • Xi'an Fourth Hospital /ID# 270562

    Xi'an, Shaanxi, 710004, China

  • Xiamen Eye Center of Xiamen University /ID# 268172

    Xiamen, Fujian, 390000, China

  • Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 274555

    Guangzhou, Guangdong, 510623, China

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