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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Macula Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy With Pit of Optic Disc, Commotio Retinae, Vitritis

Intervention / Treatment
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* Drug: Episcleral Celecoxib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase I open label study<br>Drug: Episcleral Celecoxib Other Names: Sequestered, Transscleral, Controlled-Release Celecoxib Sustained Release Transscleral Celecoxib | Drug: Episcleral Celecoxib<br>* Sustained Release Transscleral Celecoxib<br>* Other names: Sustained Release Transscleral Celecoxib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam. | The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary outcome is assessment of visual acuity. | A secondary outcome is assessment of visual acuity. | 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 anatomical changes in the macula as measured via optical coherence tomography (OCT). | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macula Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy with Pit of Optic Disc, Commotio Retinae, Vitritis