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Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02732899
Recruitment Status : Completed
First Posted : April 11, 2016
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Maturi, Raj K., M.D., P.C.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Exudative Age Related Macular Degeneration Drug: Sirolimus Drug: EYLEA Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sirolimus in Conjunction With EYLEA® (Aflibercept) Versus EYLEA® Alone for Exudative AMD
Study Start Date : April 2016
Actual Primary Completion Date : March 20, 2017
Actual Study Completion Date : April 4, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Sirolimus
Other Name: DE-109

Drug: EYLEA
Other Name: aflibercept
Active Comparator: 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
 Drug: EYLEA
Other Name: aflibercept


Outcome Measures
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Primary Outcome Measures :
  1. Change in Central Subfield Thickness on OCT From Baseline to Week 36 [ Time Frame: 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 :
  1. Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 [ Time Frame: baseline to week 36 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732899


Locations
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United States, Indiana
Raj K Maturi MD PC
Indianapolis, Indiana, United States, 46290
Sponsors and Collaborators
Maturi, Raj K., M.D., P.C.
Investigators
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Principal Investigator: Raj K Maturi, MD Raj K. Maturi, MD, PC
  Study Documents (Full-Text)

Documents provided by Maturi, Raj K., M.D., P.C.:
Study Protocol and Statistical Analysis Plan  [PDF] March 11, 2016

More Information
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Responsible Party: Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier: NCT02732899    
Other Study ID Numbers: RKM009
First Posted: April 11, 2016    Key Record Dates
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maturi, Raj K., M.D., P.C.:
AMD
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sirolimus
Aflibercept
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
 Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors