Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

This study is a single-center, masked, randomized, 36 week study, designed to evaluate the safety and treatment efficacy of intravitreal Sirolimus with adjunct EYLEA® (aflibercept) in patients with persistent edema due to neovascular AMD versus EYLEA® (aflibercept) alone. Twenty (20) patients will be randomized to receive study medication in a 1:1 ratio. Study treatment will be administered by intravitreal injections. The sham injections given in the EYLEA® alone group are needleless and they are given in order to help preserve the masking of those subjects in that treatment group.

Inclusion criteria

• Male or female patients, 50 years of age or older at baseline
• Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits.

• Ocular Inclusion Criteria (Study eye only):
• BCVA 5 - 75 (20/800-20/30), inclusive, in study eye; if both eyes are eligible, the eye with the best potential visual improvement as determined by the investigator will be selected for treatment.
• Presence of choroidal neovascularization secondary to AMD
• At least 3 previous intravitreal anti-VEGF injections in the past 6 months
• Injection of antiVEGF may be deferred for at least 4 weeks from randomization based on clinical assessment of AMD by the investigator.
• Clear ocular media and adequate pupil dilation to permit good quality photographic imaging -

Exclusion criteria

• Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
• History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.
• Participation in any investigational drug or device study within 30 days prior to baseline
• History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.

• Ocular Exclusion Criteria (Study eye only):
• Decrease of greater than 150 microns in central subfield thickness as measured by OCT since the last intravitreal injection in the study eye
• Aphakia
• History of pars plana vitrectomy in the study eye
• History of major ophthalmic surgery in the study eye in the past 3 months and any ophthalmic surgery in the study eye within the past 30 days
• History of significant ocular disease or condition other than exudative AMD that may confound results
• Uncontrolled glaucoma (defined as intraocular pressure >21mm Hg despite treatment with two or more ocular hypotensive medications at baseline)
• No active ocular or periocular infections, or ocular malignancy including lymphoma
• Presence of significant epiretinal membrane
• Significant vitreoretinal traction

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