InflammationPhase 4NCT06497699

A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery

A Phase 4 study testing Dexycu in people with Inflammation and Cataract, run by Ocumension Therapeutics (Shanghai) Co., Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Inflammation, Cataract
What is being tested?: Dexycu
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 263 participants
Where: 2 sitesChina
Study dates: 28 Oct 2021to 14 Dec 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must be able to understand and sign the informed consent form and be able to follow the study procedures.
Male or female subjects over 40 years of age who are scheduled to undergo cataract phacoemulsification surgery combined with intraocular lens implantation.

Who cannot join

Known hypersensitivity to dexamethasone or any component of the Dexycu.
History of intraocular inflammation of any cause in either eye, presence of corneal abnormalities or malnutrition.
Have high intraocular pressure, with an IOP(intraocular pressure) of > 21 mmHg in the test eye at screening, regardless of whether receiving anti-glaucoma monotherapy therapy.
Posterior capsule rupture or lens dislocation, anterior vitreal membrane rupture, vitreous prolapse and intraoperative floppy iris syndrome during cataract surgery.
Other conditions that the investigator considers inappropriate to participate the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Boao Super Hospital
Bo'ao
Hainan Traditional Chinese Medicine Hospital
Haikou, Hainan

Other trials in China

About this study

Official title: A Real-world Study to Evaluate the Efficacy and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associated With Cataract Surgery

This is a prospective, real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts.

Read the detailed description

To evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts in real-world clinical settings, medical history and follow-up data from 113 subjects of Dexycu group and 150 subjects of external control group will be prospectively collected in Hainan, China. Additionally, questionnaires will be collected from surgeons on 30 cases to evaluate the difficulty, duration and safety of the Dexycu injector.

Conditions: Inflammation, Cataract
Being tested: Dexycu
Keywords: Cataract Surgery, Postoperative Inflammation
Medical subject headings: Inflammation, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexycuDrug
single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone

Study groups in NCT06497699
Study group	Role	What they receive
Study Group	Experimental	Single injection of DEXYCU in the treatment eye after cataract surgery. Receives: Drug: Dexycu
Control Group	No intervention	The clinical routine treatment after cataract surgery was adopted without intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Anterior Chamber Cell Clearing Rate
The primary outcome is to compare the ratio of subjects with anterior chamber cell grade 0 at day 8 after cataract surgery of both Dexycu group and external control group.
The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
Measured: DAY 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202114 Dec 2023

First posted12 Jul 2024
Study start28 Oct 2021
Primary completion8 Jul 2023
Study completion14 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InflammationStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Study group:Dexycu interventional group External control group;without intervention
Masking: None (open label)
Enrolment: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06497699
Sponsor's protocol ID: OT-502-002
Status last verified: Aug 2025
First submitted: 20 Jun 2024
Last updated: 3 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Real-world Study to Evaluate the Efficacy and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associated With Cataract Surgery
ClinicalTrials.gov ID: NCT06497699
Acronym / sponsor ID: OT-502-002
Conditions: Inflammation, Cataract
Keywords: Cataract Surgery, Postoperative Inflammation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: Ocumension Therapeutics (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
Study start: 28 Oct 2021 (actual)
Primary completion: 8 Jul 2023 (actual)
Study completion: 14 Dec 2023 (actual)
First posted: 12 Jul 2024 (actual)
Results: Posted 3 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a prospective, real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Study group:Dexycu interventional group External control group;without intervention

Arm	Type	Receives
Study Group	Experimental	Drug: DexycuSingle injection of DEXYCU in the treatment eye after cataract surgery.
Control Group	No intervention	–The clinical routine treatment after cataract surgery was adopted without intervention

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects must be able to understand and sign the informed consent form and be able to follow the study procedures.
Male or female subjects over 40 years of age who are scheduled to undergo cataract phacoemulsification surgery combined with intraocular lens implantation.

Key exclusion criteria (5 listed)

Known hypersensitivity to dexamethasone or any component of the Dexycu.
History of intraocular inflammation of any cause in either eye, presence of corneal abnormalities or malnutrition.
Have high intraocular pressure, with an IOP(intraocular pressure) of > 21 mmHg in the test eye at screening, regardless of whether receiving anti-glaucoma monotherapy therapy.
Posterior capsule rupture or lens dislocation, anterior vitreal membrane rupture, vitreous prolapse and intraoperative floppy iris syndrome during cataract surgery.
Other conditions that the investigator considers inappropriate to participate the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexycusingle injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone	Drug	Study Group

Primary outcome

Anterior Chamber Cell Clearing Rate
Time frame: DAY 8
The primary outcome is to compare the ratio of subjects with anterior chamber cell grade 0 at day 8 after cataract surgery of both Dexycu group and external control group. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).

Results and safety

Results posted to the registry on 3 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	150	143
Study Group	113	110

Primary outcome: Anterior Chamber Cell Clearing Rate

Time frame: DAY 8. Count of participants. Unit: Participants

Measure	Control Group n = 149	Study Group n = 113
Value	119	95

Population analysed: 1 control group participant loss to follow up before reaching DAY 8.

Adverse events

Time frame: Through study completion, an average of 90 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	5 of 150 (3.3%)	14 of 150 (9.3%)	0 of 150
Study Group	1 of 113 (0.9%)	15 of 113 (13.3%)	1 of 113

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Zhixun Li study director

Ocumension Therapeutics (Shanghai) Co., Ltd

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexycu in people with Inflammation and Cataract, run by Ocumension Therapeutics (Shanghai) Co., Ltd at 2 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 3 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 2 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Anterior Chamber Cell Clearing Rate (time frame: DAY 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06497699.

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 3 Sep 2025.