Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

NCT02732899 | Completed Phase 2 Results

• 1 other identifier: RKM009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Exudative Age Related Macular Degeneration

Keywords

AMD

Outcome Measures

Primary Outcomes (1)

• Change in Central Subfield Thickness on OCT From Baseline to Week 36

  the amount of change in intraretinal and subretinal fluid as measured by microns of central subfield thickness (CST) on Heidelberg Optical Coherence Tomography (OCT)

  baseline to week 36

Secondary Outcomes (1)

• Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36

  baseline to week 36

Study Arms (2)

Group 1

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.

Drug: Sirolimus; Drug: EYLEA

Group 2

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

Drug: EYLEA

Interventions

Sirolimus DRUG

Also known as: DE-109

Group 1

EYLEA DRUG

Also known as: aflibercept

Group 1; Group 2

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 -

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Maturi, Raj K., M.D., P.C.: lead

Study Sites (1)

Raj K Maturi MD PC

Indianapolis, Indiana, 46290, United States

Location

Related Publications (1)

• 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.

  PMID: 36604756 DERIVED

MeSH Terms

Interventions

Sirolimus; aflibercept

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Raj K. Maturi, MD
• Organization: Raj K. Maturi, MD, PC

rmaturi@gmail.com

317-817-1414

Study Officials

• Raj K Maturi, MD

  Raj K. Maturi, MD, PC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 11, 2016
• Study Start: April 1, 2016
• Primary Completion: March 20, 2017
• Study Completion: April 4, 2017
• Last Updated: February 14, 2018
• Results First Posted: February 14, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)