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Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet 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: NCT02357342
Recruitment Status : Completed
First Posted : February 6, 2015
Results First Posted : June 5, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Maturi, Raj K., M.D., P.C.

Study Description
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Brief Summary:
Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Sirolimus Drug: Standard of Care intravitreal injections of anti-VEGF Phase 2

Detailed Description:
Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 1:1 ratio. Over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. Treatment with Sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. For subjects in the extension Sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. Subjects in the standard of care group will receive anti-VEGF injections or sham monthly. Retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (CNV)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sirolimus Versus AntiVEGF for Wet AMD
Study Start Date : April 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sirolimus
Intravitreal Sirolimus
 Drug: Sirolimus
intravitreal injection
Other Name: DE-109
Active Comparator: Standard of Care intravitreal anti-VEGF
anti-VEGF intravitreal injections
 Drug: Standard of Care intravitreal injections of anti-VEGF
intravitreal injections of anti-VEGF
Other Name: avastin,bevacizumab, eylea, aflibercept,


Outcome Measures
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Primary Outcome Measures :
  1. Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography [ Time Frame: Baseline to 6 months ]
    Change in edema from baseline to month 6 as measured by mean difference in microns of central subfield thickness on Heidelberg optical coherence topography in each treatment group

  2. Visual Acuity [ Time Frame: Baseline to 6 months ]
    number of subjects with gain of 0-4 letters of visual acuity


Secondary Outcome Measures :
  1. Visual Acuity (Best Corrected Visual Acuity) [ Time Frame: baseline to 6 months ]
    number of subjects with gain of 5 or more letters of visual acuity


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • best corrected visual acuity of 5-65, inclusive, in study eye
  • presence of choroid neovascularization secondary to AMD
  • persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the past 5 months

Exclusion Criteria:

  • greater than 100 micron decrease in central subfield thickness on Optical Coherence Topography (OCT) since last standard of care visit
  • history of major ophthalmic surgery in the study eye in the past 3 months
  • history of significant ocular disease or condition other than exudative AMD that may confound results
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): NCT02357342


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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier: NCT02357342    
Other Study ID Numbers: RKM008
First Posted: February 6, 2015    Key Record Dates
Results First Posted: June 5, 2017
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sirolimus
Aflibercept
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
 Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors