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

Phase 4

Completed

• Conditions: Inflammation; Cataract
• Interventions: Drug: Dexycu

• Registration Number: NCT06497699
• Lead Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-10-28
• Primary Completion: 2023-07-08
• Study Completion: 2023-12-14
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-12
• Results First Submitted: 2025-07-29
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Results First Posted: 2025-09-03
• Last Update Posted: 2025-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Dexycu	Single injection of DEXYCU in the treatment eye after cataract surgery.

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Cell Clearing Rate	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).

Trial Locations

Locations (2)

Hainan Traditional Chinese Medicine Hospital; 🇨🇳 Haikou, Hainan, China

Boao Super Hospital; 🇨🇳 Bo'ao, China