Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD
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|ClinicalTrials.gov Identifier: NCT02732899|
Recruitment Status : Completed
First Posted : April 11, 2016
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Exudative Age Related Macular Degeneration||Drug: Sirolimus Drug: EYLEA||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
Other Name: DE-109
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
Other Name: aflibercept
- 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)
- Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 [ Time Frame: baseline to week 36 ]
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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|
- 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 -
- 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
- 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
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
|United States, Indiana|
|Raj K Maturi MD PC|
|Indianapolis, Indiana, United States, 46290|
|Principal Investigator:||Raj K Maturi, MD||Raj K. Maturi, MD, PC|
Documents provided by Maturi, Raj K., M.D., P.C.:
|Responsible Party:||Maturi, Raj K., M.D., P.C.|
|Other Study ID Numbers:||
|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|
Physiological Effects of Drugs
Angiogenesis Modulating Agents