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.