Phase 2
N=20
Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD
Exudative Age Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02732899 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Feb 2018
Primary outcome: Primary: Change in Central Subfield Thickness on OCT From Baseline to Week 36 — -54; -.1 microns
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sirolimus (Drug); EYLEA (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Maturi, Raj K., M.D., P.C.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Central Subfield Thickness on OCT From Baseline to Week 36 |
-54; -.1 | — |
| SECONDARY Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 |
2.5; 0.8 | — |
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.
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
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Data sourced from ClinicalTrials.gov (NCT02732899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.