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Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

Primary Purpose

Exudative Age Related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sirolimus

EYLEA

About this trial

This is an interventional treatment trial for Exudative Age Related Macular Degeneration focused on measuring AMD

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
-

Sites / Locations

Raj K Maturi MD PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02732899

First Posted

April 5, 2016

Last Updated

January 18, 2018

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT02732899

Brief Title

Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

Official Title

Sirolimus in Conjunction With EYLEA® (Aflibercept) Versus EYLEA® Alone for Exudative AMD

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

March 20, 2017 (Actual)

Study Completion Date

April 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Exudative Age Related Macular Degeneration

Keywords

AMD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Other Intervention Name(s)

DE-109

Intervention Type

Drug

Intervention Name(s)

EYLEA

Other Intervention Name(s)

aflibercept

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

baseline to week 36

Secondary Outcome Measure Information:

Title

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

Time Frame

baseline to week 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raj K Maturi, MD

Organizational Affiliation

Raj K. Maturi, MD, PC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Raj K Maturi MD PC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

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