Study of Dexycu in Treating Intraocular Inflammation

Phase 3

Completed

• Conditions: Inflammation; Cataract

• Registration Number: NCT06429306
• Lead Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-11
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. The patient must provide written informed consent by signing the Informed Consent<br> approved by the Institutional Review Board (IRB).<br><br> 2. Male or female patients at least 40 years of age scheduled for unilateral cataract<br> surgery by phacoemulsification with posterior chamber intraocular lens implantation.<br><br> 3. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 in<br> the study eye and better than 20/200 in the fellow eye.<br><br> 4. The patient must be considered by the Investigator to have visual acuity potential.<br> greater than 20/30 in the study eye.<br><br> 5. The patient must have a corneal endothelial cell count by specular microscopy in the<br> study eye of at least 2000 cells/mm2 with normal cell morphology.<br><br> 6. A female patient of childbearing potential must have a negative pregnancy test on<br> Day 0 and be using an effective method of birth control from Screening for the<br> duration of the study.<br><br> 7. The patient must be willing and able to understand and comply with the study<br> procedures and to communicate meaningfully with study personnel.<br><br>Exclusion Criteria:<br><br> 1. Patients who have used any ocular, topical or oral corticosteroids within 7 days<br> prior to Day 0.<br><br> 2. Patients who have received a periocular corticosteroid injection in the study eye in<br> the 3 months prior to screening.<br><br> 3. Patients who have received any intravitreal corticosteroid delivery vehicle<br> (e.g.,Retisert, Ozurdex, Iluvien) in the study eye at any time.<br><br> 4. Patients who anticipate requiring treatment with any corticosteroids( by any<br> route,except inhalation), during the study.<br><br> 5. Patients with an allergy or hypersensitivity to dexamethasone.<br><br> 6. Patients who are known steroid responders (corticosteroid-related intraocular<br> pressure elevation in either eye).<br><br> 7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior<br> to Day 0.<br><br> 8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye<br> within 6 months prior to screening.<br><br> 9. Patients who have undergone prior intraocular laser surgery in the study eye within<br> 3 months prior to screening.<br><br> 10. Patients with planned intraocular or laser surgery in the study eye for the duration<br> of the study.<br><br> 11. Patients with any signs of intraocular inflammation in either eye at screening.<br><br> 12. Patients with evidence of corneal abnormality or dystrophy (e.g. opacities,<br> guttae,clouding, etc.) or an inability to obtain an acceptable specular micrograph<br> at Screening.<br><br> 13. Patients with a history of chronic uveitis from any cause in either eye.<br><br> 14. Patients who have received any prior intravitreal injections in the study eye.<br><br> 15. Patients with glaucomatous optic neuropathy or glaucomatous visual field loss in<br> either eye.<br><br> 16. Patients with ocular hypertension with an IOP in the study eye > 21 mm Hg at<br> Screening with or without treatment with anti-glaucoma monotherapy.<br><br> 17. Patients with ocular hypertension receiving treatment with two or more anti-glaucoma<br> Medications.<br><br> 18. Patients treated with any investigational product within 30 days prior to screening<br> or patients enrolled previouslyc study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anterior chamber cell clearing rate

Secondary Outcome Measures

Name	Time	Method
Anterior chamber cell clearing rates;Anterior chamber flare clearing rates;Anterior chamber cell & flare clearing rates;Mean anterior chamber cell score and mean anterior chamber flare score;Mean anterior chamber cell + flare score