Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

NCT ID: NCT02732899

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-04-04

Brief 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.

Detailed 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.

Conditions

Exudative Age Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

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.

Group Type: EXPERIMENTAL

Sirolimus

Intervention Type: DRUG

EYLEA

Intervention Type: DRUG

Group 2

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

Group Type: ACTIVE_COMPARATOR

EYLEA

Intervention Type: DRUG

Interventions

Sirolimus

Intervention Type: DRUG

EYLEA

Intervention Type: DRUG

Other Intervention Names

DE-109; aflibercept

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.

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.

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

-

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maturi, Raj K., M.D., P.C.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raj K Maturi, MD

Role: PRINCIPAL_INVESTIGATOR

Raj K. Maturi, MD, PC

Locations

Raj K Maturi MD PC

Indianapolis, Indiana, United States

Countries

United States

References

Rowe LW, Minturn RJ, Burgett LA, Bracha P, Maturi RK. Intravitreal sirolimus with adjunct aflibercept versus aflibercept monotherapy for persistent, exudative age-related macular degeneration: a pilot study. Int J Retina Vitreous. 2023 Jan 5;9(1):1. doi: 10.1186/s40942-022-00437-6.

Reference Type: DERIVED

PMID: 36604756 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RKM009

Identifier Type: -

Identifier Source: org_study_id