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

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

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.

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.