| Eligibility |
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.
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