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

Sponsor

Targeted Therapy Technologies, LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04120636

Collaborator

(none)

Enrollment

Location

Arm

31.8

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macula Edema Radiation Retinopathy Branch Retinal Vein Occlusion Epiretinal Membrane Central Serous Retinopathy With Pit of Optic Disc Commotio Retinae Vitritis	Drug: Episcleral Celecoxib	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Study of Sequestered Transscleral, Controlled-Release Celecoxib Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous

Actual Study Start Date :

Mar 5, 2021

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase I open label study Drug: Episcleral Celecoxib Other Names: Sequestered, Transscleral, Controlled-Release Celecoxib Sustained Release Transscleral Celecoxib	Drug: Episcleral Celecoxib Sustained Release Transscleral Celecoxib Other Names: Sustained Release Transscleral Celecoxib

Arm

Intervention/Treatment

Experimental: Phase I open label study

Drug: Episcleral Celecoxib Other Names: Sequestered, Transscleral, Controlled-Release Celecoxib Sustained Release Transscleral Celecoxib

Drug: Episcleral Celecoxib

Sustained Release Transscleral Celecoxib

Other Names:

Sustained Release Transscleral Celecoxib

Outcome Measures

Primary Outcome Measures

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

A secondary outcome is assessment of visual acuity. [12 Months]
A secondary outcome is assessment of visual acuity.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.