Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD
Condition: Exudative Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Sirolimus; EYLEA
Intervention MeSH terms: Sirolimus; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 50 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: AMD

Summary:

      To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA
      in subjects with exudative age related macular degeneration (AMD) with persistent
      intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal
      anti-vascular endothelial growth factor (antiVEGF) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients, 50 years of age or older at baseline

          2. 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):

          3. 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.

          4. Presence of choroidal neovascularization secondary to AMD

          5. At least 3 previous intravitreal anti-VEGF injections in the past 6 months

          6. Injection of antiVEGF may be deferred for at least 4 weeks from randomization based on
             clinical assessment of AMD by the investigator.

          7. Clear ocular media and adequate pupil dilation to permit good quality photographic
             imaging -

        Exclusion Criteria:

          1. Females who are pregnant, nursing, planning a pregnancy or who are of childbearing
             potential not using a reliable method of contraception.

          2. History or current evidence of hypersensitivity to any components of the study
             medication or fluorescein, as assessed by the investigator.

          3. Participation in any investigational drug or device study within 30 days prior to
             baseline

          4. 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):

          5. Decrease of greater than 150 microns in central subfield thickness as measured by OCT
             since the last intravitreal injection in the study eye

          6. Aphakia

          7. History of pars plana vitrectomy in the study eye

          8. 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

          9. History of significant ocular disease or condition other than exudative AMD that may
             confound results

         10. Uncontrolled glaucoma (defined as intraocular pressure >21mm Hg despite treatment with
             two or more ocular hypotensive medications at baseline)

         11. No active ocular or periocular infections, or ocular malignancy including lymphoma

         12. Presence of significant epiretinal membrane

         13. Significant vitreoretinal traction

             -