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

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.