Sirolimus to Treat Diabetic Macular Edema

Exclusion Criteria

• •1. History of chronic renal failure requiring dialysis or kidney transplant.
• •2. Positive serum or urine pregnancy test or currently lactating for women of childbearing potential.
• •3. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
• •4. Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.
• •5. History of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years that could be worsened by immunosuppression.\*
• •\*The risk of immunosuppression must be determined by an oncology consultation prior to enrollment.
• •6. Laboratory values outside normal limits and considered clinically significant by the investigator.
• •7. Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110).
• •8. History of intravitreal anti-VEGF therapy or subtenon/intravitreal steroids in either eye within three months prior to study entry.
• •9. History of treatment with systemic anti-VEGF agents or steroids within one year prior to study entry.
• •10. Participant is currently taking one of the following drugs: amprenavir, atazanavir, clarithromycin, darunavir, delavirdine, erythromycin, fluconazole (at doses of 200mg or greater), fluvoxamine, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, quinupristin, ritonavir, saquinavir, telithromycin, troleandomycin, verapamil or voriconazole.
• •1. Macular edema is considered to be due to a cause other than diabetic macular edema.
• •2. An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition, etc.).
• •3. An ocular condition is present (other than diabetic retinopathy) 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, Irvine-Gass Syndrome, etc.).
• •4. Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
• •5. History of focal/grid macular photocoagulation within 12 weeks (three months) prior to study entry.
• •6. History of panretinal scatter photocoagulation (PRP) within four months prior to study entry.
• •7. Anticipated need for PRP in the four months following study entry.
• •8. History of prior pars plana vitrectomy.
• •9. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior six months or anticipated within the next six months following study entry.
• •10. History of (Yttrium Aluminium Garnet) YAG laser capsulotomy performed within two months prior to study entry.
• •11. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.