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

NCT06497699 | Completed Phase 4 Results FDA Drug

• 1 other identifier: OT-502-002
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Inflammation; Cataract

Keywords

Cataract Surgery; Postoperative Inflammation

Outcome Measures

Primary Outcomes (1)

• 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).

  DAY 8

Study Arms (2)

Study Group

EXPERIMENTAL

Single injection of DEXYCU in the treatment eye after cataract surgery.

Drug: Dexycu

Control Group

NO INTERVENTION

The clinical routine treatment after cataract surgery was adopted without intervention

Interventions

Dexycu DRUG

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

Study Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ocumension Therapeutics (Shanghai) Co., Ltd: lead

Study Sites (2)

Hainan Traditional Chinese Medicine Hospital

Haikou, Hainan, China

Location

Boao Super Hospital

Bo'ao, China

Location

MeSH Terms

Conditions

Inflammation; Cataract

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Ocumension Therapeutics (Shanghai) Co., Ltd

clinicalop@ocumension.com

2289 3653

Study Officials

• Zhixun Li

  Ocumension Therapeutics (Shanghai) Co., Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study group:Dexycu interventional group External control group;without intervention

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 12, 2024
• Study Start: October 28, 2021
• Primary Completion: July 8, 2023
• Study Completion: December 14, 2023
• Last Updated: September 3, 2025
• Results First Posted: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)