Trial Outcomes & Findings for Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD (NCT NCT02732899)
NCT ID: NCT02732899
Last Updated: 2018-02-14
Results Overview
the amount of change in intraretinal and subretinal fluid as measured by microns of central subfield thickness (CST) on Heidelberg Optical Coherence Tomography (OCT)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
baseline to week 36
Results posted on
2018-02-14
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD
Baseline characteristics by cohort
| Measure |
Group 1
n=10 Participants
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
|
Group 2
n=10 Participants
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
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
77 years
n=7 Participants
|
74 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to week 36the amount of change in intraretinal and subretinal fluid as measured by microns of central subfield thickness (CST) on Heidelberg Optical Coherence Tomography (OCT)
Outcome measures
| Measure |
Group 1
n=10 Participants
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
|
Group 2
n=10 Participants
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
|
|---|---|---|
|
Change in Central Subfield Thickness on OCT From Baseline to Week 36
|
-54 microns
Interval -74.0 to -34.0
|
-.1 microns
Interval -0.6 to 0.5
|
SECONDARY outcome
Timeframe: baseline to week 36Outcome measures
| Measure |
Group 1
n=10 Participants
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
|
Group 2
n=10 Participants
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
|
|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36
|
2.5 letters
Interval 1.6 to 3.8
|
0.8 letters
Interval 0.444 to 2.2
|
Adverse Events
Group 1
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=10 participants at risk
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
|
Group 2
n=10 participants at risk
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
|
|---|---|---|
|
Vascular disorders
worsening hypertension
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Gastrointestinal disorders
pancreatitis
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
Other adverse events
| Measure |
Group 1
n=10 participants at risk
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
|
Group 2
n=10 participants at risk
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
|
|---|---|---|
|
Eye disorders
worsening subretinal hemorrhage
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Eye disorders
progressed posterior capsule opacification
|
20.0%
2/10 • Number of events 2 • 6 months
|
0.00%
0/10 • 6 months
|
|
Renal and urinary disorders
urinary tract infection
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Infections and infestations
sinusitis
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
dot hemorrhage on retina
|
20.0%
2/10 • Number of events 2 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
progressed nuclear sclerotic cataract
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
subretinal hemorrhage
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
30.0%
3/10 • Number of events 4 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
hyperemia
|
20.0%
2/10 • Number of events 2 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
increased metemorphopsia
|
20.0%
2/10 • Number of events 3 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
foreign body sensation
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
eye pain
|
10.0%
1/10 • Number of events 2 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Infections and infestations
tooth infection
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
chalazion
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
General disorders
combigan allergy
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
epiphora
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Eye disorders
eyelid edema
|
10.0%
1/10 • Number of events 1 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place