Trial Outcomes & Findings for A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery (NCT NCT06497699)

Last Updated: 2025-09-03

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

263 participants

Primary outcome timeframe

DAY 8

Results posted on

2025-09-03

Participant Flow

113 recruited to the study group treat with DEXYCU postsurgerically. 150 recruited to control group which observation study was conducted.

Unit of analysis: Eye

Participant milestones

Participant milestones
Measure	Control Group The clinical routine treatment after cataract surgery was adopted without intervention	Study Group Single injection of DEXYCU in the treatment eye after cataract surgery. Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone
Overall Study STARTED	150 150	113 113
Overall Study COMPLETED	143 143	110 110
Overall Study NOT COMPLETED	7 7	3 3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=150 Participants The clinical routine treatment after cataract surgery was adopted without intervention	Study Group n=113 Participants Single injection of DEXYCU in the treatment eye after cataract surgery. Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone	Total n=263 Participants Total of all reporting groups
Age, Customized < = 60 years	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Age, Customized > 60 years	135 Participants n=5 Participants	96 Participants n=7 Participants	231 Participants n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	55 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	58 Participants n=7 Participants	124 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	150 Participants n=5 Participants	113 Participants n=7 Participants	263 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	149 participants n=5 Participants	113 participants n=7 Participants	262 participants n=5 Participants

PRIMARY outcome

Timeframe: DAY 8

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

Outcome measures

Outcome measures
Measure	Control Group n=149 Participants The clinical routine treatment after cataract surgery was adopted without intervention	Study Group n=113 Participants Single injection of DEXYCU in the treatment eye after cataract surgery. Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone
Anterior Chamber Cell Clearing Rate	119 Participants	95 Participants

Adverse Events

Control Group

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Study Group

Serious events: 1 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Control Group n=150 participants at risk The clinical routine treatment after cataract surgery was adopted without intervention	Study Group n=113 participants at risk Single injection of DEXYCU in the treatment eye after cataract surgery. Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone
Eye disorders Endophthalmitis	0.00% 0/150 • Through study completion, an average of 90 days	0.88% 1/113 • Number of events 1 • Through study completion, an average of 90 days
Eye disorders Diplopia	0.67% 1/150 • Number of events 1 • Through study completion, an average of 90 days	0.00% 0/113 • Through study completion, an average of 90 days
Eye disorders Macular Oedema	2.7% 4/150 • Number of events 4 • Through study completion, an average of 90 days	0.00% 0/113 • Through study completion, an average of 90 days

Other adverse events

Other adverse events
Measure	Control Group n=150 participants at risk The clinical routine treatment after cataract surgery was adopted without intervention	Study Group n=113 participants at risk Single injection of DEXYCU in the treatment eye after cataract surgery. Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone
Eye disorders Corneal endothelial cell loss	9.3% 14/150 • Number of events 14 • Through study completion, an average of 90 days	13.3% 15/113 • Number of events 15 • Through study completion, an average of 90 days

Additional Information

Director of Clinical Trials

Ocumension Therapeutics (Shanghai) Co., Ltd

Phone: 2289 3653

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place