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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-13

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)

NCT02188173

Macular Edema

COMPLETED

Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema.

NCT02121197

Diabetic Macular Edema

COMPLETED

A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated

NCT03953807

Diabetic Macular Edema

COMPLETED PHASE4

A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion

NCT01903720

Macular Edema Retinal Vein Occlusion

COMPLETED PHASE4

Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema

NCT02399657

Diabetes Mellitus Macular Edema Retinal Exudates and Deposits

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Macular Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OZURDEX

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No