Study of Dexycu in Treating Intraocular Inflammation

NCT06429306 | Completed Phase 3 FDA Drug

• 1 other identifier: OT-502-001
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase III, prospective, randomised, double-masked, placebo-controlled, parallel-design, multicenter study of the efficacy, safety and pharmacokinetics of 9% dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery.

Conditions

Inflammation; Cataract

Keywords

Cataract Surgery; Postoperative Inflammation

Outcome Measures

Primary Outcomes (1)

• Anterior chamber cell clearing rate

  The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. 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

Secondary Outcomes (5)

• Anterior chamber cell clearing rates

  DAY 1 & 3 & 15 & 30

• Anterior chamber flare clearing rates

  DAY 1 & 3 & 8 & 15 & 30

• Anterior chamber cell & flare clearing rates

  DAY 1 & 3 & 15 & 30

• Mean anterior chamber cell score and mean anterior chamber flare score

  DAY 8 & 15

• Mean anterior chamber cell + flare score

  DAY 8 &15

Study Arms (2)

Dexamethasone intraocular injection

EXPERIMENTAL

Dexamethasone implant single injection in the treatment eye after cataract surgery.

Drug: Dexycu

Placebo

PLACEBO COMPARATOR

Blank placebo single injection in the treatment eye after cataract surgery.

Drug: Placebo

Interventions

Dexycu DRUG

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

Also known as: Investigational product

Dexamethasone intraocular injection

Placebo DRUG

Acetyl triethyl citrate

Placebo

Eligibility Criteria

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

You may qualify if:

• The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
• Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
• The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye and better than 20/200 in the fellow eye.
• The patient must be considered by the Investigator to have visual acuity potential. greater than 20/30 in the study eye.
• The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
• A female patient of childbearing potential must have a negative pregnancy test on Day 0 and be using an effective method of birth control from Screening for the duration of the study.
• The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.

You may not qualify if:

• Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
• Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
• Patients who have received any intravitreal corticosteroid delivery vehicle (e.g.,Retisert, Ozurdex, Iluvien) in the study eye at any time.
• Patients who anticipate requiring treatment with any corticosteroids( by any route,except inhalation), during the study.
• Patients with an allergy or hypersensitivity to dexamethasone.
• Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
• Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
• Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
• Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
• Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
• Patients with any signs of intraocular inflammation in either eye at screening.
• Patients with evidence of corneal abnormality or dystrophy (e.g. opacities, guttae,clouding, etc.) or an inability to obtain an acceptable specular micrograph at Screening.
• Patients with a history of chronic uveitis from any cause in either eye.
• Patients who have received any prior intravitreal injections in the study eye.
• Patients with glaucomatous optic neuropathy or glaucomatous visual field loss in either eye.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai General Hospital

Shanghai, 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

Study Officials

• Zhixun Li

  Ocumension Therapeutics (Shanghai) Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 24, 2024
• Study Start: August 22, 2022
• Primary Completion: November 24, 2023
• Study Completion: April 9, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)