Exudative Age Related Macular Degeneration
Conditions
Keywords
AMD
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.
Interventions
DRUGEYLEA
DRUGSirolimus
Sponsors
Maturi, Raj K., M.D., P.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Subfield Thickness on OCT From Baseline to Week 36 | 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
| Measure | Time frame |
|---|---|
| Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 | baseline to week 36 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Sirolimus
EYLEA | 10 |
| 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
EYLEA | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Continuous | 71 years | 77 years | 74 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 10 / 10 | 5 / 10 |
| serious Total, serious adverse events | 3 / 10 | 0 / 10 |
Outcome results
Primary
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)
Time frame: baseline to week 36
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | Change in Central Subfield Thickness on OCT From Baseline to Week 36 | -54 microns |
| Group 2 | Change in Central Subfield Thickness on OCT From Baseline to Week 36 | -.1 microns |
Secondary
Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36
Time frame: baseline to week 36
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 | 2.5 letters |
| Group 2 | Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 | 0.8 letters |