a phase i study of episcleral dexamethasone for treatment of macular edema

Conditions: Refractory Diabetic Macular Edema

Summary: 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.

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.

Eligibility criteria:
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.