Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole

Phase 1

Active, not recruiting

• Conditions: Macula Edema; Epiretinal Membrane; Central Serous Retinopathy With Pit of Optic Disc; Branch Retinal Vein Occlusion; Commotio Retinae; Radiation Retinopathy; Vitritis
• Interventions: Drug: Episcleral Celecoxib

• Registration Number: NCT04120636
• Lead Sponsor: Targeted Therapy Technologies, LLC

Brief Summary

This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.

Detailed Description

This phase I trial will assess primarily the safety and secondarily anti-inflammatory/neovascular effect of Episcleral Celecoxib in patients suffering from macular edema \& inflammatory disorders of the eye posterior pole Including sclera, choroid, retina, or vitreous. Celecoxib is a specific cyclooxygenase-2 inhibitor that possesses anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. Non-clinical studies have documented the activity of Celecoxib in reducing leakage of the blood-retina barrier as well as inhibiting vascular endothelial growth factor (VEGF) and prostaglandin E2 (PGE2) expression in the retina of diabetic rats. The underlying mechanisms for its anti-inflammatory and anti-angiogenic properties have been extensively characterized. The investigators hypothesize that Episcleral Celecoxib is safe, tolerable and that its anti-inflammatory/anti-neovascular activity will reduce macular edema and improve vision in patients with macular edema. Objective: to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Celecoxib in patients with macular edema and other inflammatory disorders of the posterior pole including retina, choroid and vitreous to secondarily assess efficacy in reducing macular edema and improving visual function. Methods: The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT).

Study Timeline

• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2021-03-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Age >= 18 years;
• Visual acuity letter score in study eye < 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320);
• Ophthalmoscopic evidence of center-involved macular edema, within the central subfield (CSF); • Inflammatory disorders of the sclera, choroid, retina or vitreous

Exclusion Criteria

• Inability to understand informed consent, cooperate with testing or return to follow up visits;
• Pregnant or lactating women;
• Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase I open label study	Episcleral Celecoxib	Drug: Episcleral Celecoxib Other Names: * Sequestered, Transscleral, Controlled-Release Celecoxib * Sustained Release Transscleral Celecoxib

Primary Outcome Measures

Name	Time	Method
The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.	12 Months	The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.

Secondary Outcome Measures

Name	Time	Method
A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).	12 Months	A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
A secondary outcome is assessment of visual acuity.	12 Months	A secondary outcome is assessment of visual acuity.

Trial Locations

Locations (1)

Stanford Medicine Ophthalmology; 🇺🇸 Palo Alto, California, United States