Episcleral Dexamethasone 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 anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other 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 effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. 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) and fluorescein angiogram.

Official Title
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Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone 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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Macular 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 Dexamethasone


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 Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone Other Names: • Sustained Release Transscleral Dexamethasone | Drug: Episcleral Dexamethasone<br>* Sustained Release Episcleral Dexamethasone<br>* Other names: Sustained Release Transscleral Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam. | Assessment of ocular safety 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. | 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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Macular Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy with Pit of Optic Disc, Commotio Retinae, Vitritis