Overview

This trial is active, not recruiting.

Condition exudative age related macular degeneration
Treatments sirolimus, eylea
Phase phase 3
Targets FKBP-12, mTOR, VEGF
Sponsor Maturi, Raj K., M.D., P.C.
Start date April 2016
End date July 2017
Trial size 20 participants
Trial identifier NCT02732899, RKM009

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 antiVEGF treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.
sirolimus DE-109
eylea aflibercept
(Active Comparator)
Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment
eylea aflibercept

Primary Outcomes

Measure
change in edema
time frame: baseline to week 36

Secondary Outcomes

Measure
change in best corrected visual acuity (BCVA)
time frame: baseline to week 36
number of injections required
time frame: baseline to week 36

Eligibility Criteria

Male or female participants from 50 years up to 99 years old.

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 Anti-VEGF 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

Additional Information

Official title Sirolimus in Conjunction With EYLEA® (Aflibercept) Versus EYLEA® Alone for Exudative AMD
Principal investigator Raj K Maturi, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Maturi, Raj K., M.D., P.C..