A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema

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 refractory diabetic macular edema.

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 refractory diabetic macular edema. 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 reduce macular edema and improve vision in patients with diabetic macular edema.

Official Title
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A Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered From an Episcleral Reservoir for Treatment of Macular Edema Secondary to Diabetes and Other Causes

Conditions
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Refractory Diabetic Macular Edema

Intervention / Treatment
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* Drug: Episcleral Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type I or II diabetes; 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 DME, within the central subfield (CSF); OCT CSF thickness value (microns): Zeiss Cirrus: ≥290 in women; ≥305 in men Heidelberg Spectralis: ≥305 in women; ≥320 in men Previous treatment with laser, anti-VEGF therapy and/or intravitreal steroids; No previous history of glaucoma or steroid-induced intraocular pressure response in either eye. Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; Retinal or optic nerve neovascularization on clinical exam, fundus photographs, or fluorescein angiograms; Evidence of external ocular infection; History of open-angle glaucoma or intraocular pressure >= 25 mmHg; History of steroid-induced IOP elevation that required IOP-lowering treatment; History of prior herpetic ocular infection; History of intravitreal or periocular corticosteroids within 3 months prior to enrollment; History of macular laser photocoagulation within 4 months prior to enrollment; History of antiangiogenic therapy within 4 weeks prior to enrollment; History of panretinal photocoagulation (PRP) within 4 months prior to enrollment or anticipated need for PRP in the next 6 months following enrollment; Presence of vitreomacular traction, epiretinal membrane, tractional retinal detachment, vitreous hemorrhage and or any ocular condition that the investigator judges could interfere in the safety and efficacy assessments; No other major non-diabetic pathology, or anticipation of such in the next 6 months following enrollment that in the opinion of the investigator would substantially and adversely affect assessment of safety and toxicity during the study; Participation in another clinical trial of non-approved medical treatment within 3 months prior to enrollment; Degenerative myopia; Malignant intraocular disease; 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 1<br>Phase I open label study | Drug: Episcleral Dexamethasone<br>* Sequestered Transscleral, Controlled-Release 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 |
| --- | --- | --- |
| The primary outcome measure of the study is safety assessment. | The main outcome of the study is safety assessment. | 12 Months | 

Secondary Outcome Measures

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