Diabetic Macular EdemaNCT06548568
A Real-world Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Adult Participants With Diabetic Macular Edema in China
An observational study of Diabetic Macular Edema, run by AbbVie at 13 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 110 participants
- Where
- 13 sitesChina
- Study dates
- 13 Nov 2024to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample: participants with diabetic macular edema (DME) who resided in China.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Peking University People'S Hospital /ID# 274505
Beijing, Beijing Municipality, 100034
West China Hospital of Sichuan University /ID# 273656
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Dalian Medical University /ID# 270563
Dalian, Liaoning, 116000
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 274555
Guangzhou, Guangdong, 510623
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 273617
Hangzhou, Zhejiang, 310009
Qingdao Eye Hospital Of Shandong First Medical University /ID# 268173
Qingdao, Shandong, 266071
Shanghai General hospital /ID# 270376
Shanghai, Shanghai Municipality, 200080
Shanxi Eye Hospital /ID# 270564
Taiyuan, 030072
The Affiliated Eye Hospital Of Wenzhou Medical University /ID# 274466
Wenzhou, Zhejiang, 325027
General Hospital of Central Theater Command /ID# 273618
Wuhan, Hubei, 430000
Xi'an Fourth Hospital /ID# 270562
Xi'an, Shaanxi, 710004
Xiamen Eye Center of Xiamen University /ID# 268172
Xiamen, Fujian, 390000
Henan Provincial Eye Hosptial /ID# 272424
Zhengzhou, Henan, 450003
About this study
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
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.
Read more
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.
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, OZURDEX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OZURDEX | Participants with diabetic macular edema prescribed OZURDEX in routine clinical practice are observed from the first dose for up to 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The AESIs can include the following: cataracts, elevated IOP and conjunctival hemorrhage.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start13 Nov 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548568
- Sponsor's protocol ID
- P24-425
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06548568
- Acronym / sponsor ID
- P24-425
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, OZURDEX
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OZURDEX | – | –Participants with diabetic macular edema prescribed OZURDEX in routine clinical practice are observed from the first dose for up to 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample: participants with diabetic macular edema (DME) who resided in China.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Concurrent participation in interventional clinical research that required treatment or use of an investigational agent.
- Participants for whom OZURDEX® is contraindicated:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs)
Time frame: Up to approximately 24 months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The AESIs can include the following: cataracts, elevated IOP and conjunctival hemorrhage.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Active, not recruitingObservational study
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by AbbVie at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.