Treatment for CI-DME in Eyes With Very Good VA Study

Inclusion Criteria

• •1. Age \>= 18 years
• •2. Diagnosis of diabetes mellitus (type 1 or type 2)
• •Any one of the following will be considered to be sufficient evidence that diabetes is present:
• •1. Current regular use of insulin for the treatment of diabetes
• •2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
• •3. Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization (WHO) criteria.
• •3. Able and willing to provide informed consent.
• •Meets all of the following ocular criteria in at least the one eye:
• •1. Best corrected E-ETDRS visual acuity letter score ≥ 79 (approximate Snellen equivalent 20/25 or better) at two consecutive visits within 1 to 28 days.
• •2. On clinical exam, definite retinal thickening due to DME involving the center of the macula.
• •3. Diabetic macular edema confirmed on OCT (equivalent to CSF thickness on OCT ≥250 microns on Zeiss Stratus or gender-specific spectral domain OCT equivalent) at two consecutive visits within 1 to 28 days.
• •(a) Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality.
• •4. The investigator is comfortable with the eye being randomized to any of the three treatment groups (observation, laser, or anti-VEGF initially).
• •(a) If focal/grid photocoagulation is contraindicated because all leaking microaneurysms are too close to the fovea or the investigator believes the DME that is present will not benefit from focal/grid photocoagulation, the eye should not be enrolled.
• •5. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.
• •2. An ocular condition is present such that, in the opinion of the investigator, any visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
• •3. An ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
• •4. Cataract is present that, in the opinion of the investigator, may alter visual acuity during the course of the study.
• •5. Any history of prior laser or other surgical, intravitreal, or peribulbar treatment for DME (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, or anti-VEGF).
• •6. History of topical steroid or nonsteroidal anti-inflammatory drugs (NSAID) treatment within 30 days prior to randomization.
• •7. History of intravitreal or peribulbar corticosteroid within 4 months prior to randomization for an ocular condition other than DME.
• •8. Any history of or anticipated need for intravitreal anti-VEGF within the next 6 months for an ocular condition other than DME (e.g. choroidal neovascularization, central retinal vein occlusion, PDR).
• •9. History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
• •10. Any history of vitrectomy.
• •11. History of major ocular surgery (cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
• •12. History of YAG capsulotomy performed within 2 months prior to randomization.
• •13. Aphakia.
• •14. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.