Trial Outcomes & Findings for Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration (NCT NCT01926977)
NCT ID: NCT01926977
Last Updated: 2016-03-03
Results Overview
Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
100 participants
Primary outcome timeframe
24 to 48 hours (visit #1) and 5 to 7 days (visit #2)
Results posted on
2016-03-03
Participant Flow
Participant milestones
| Measure |
Ranibizumab 0.5mg Intravitreal Injection
Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg.
|
Aflibercept 2.0mg Intravitreal Injection
Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
53
|
|
Overall Study
COMPLETED
|
47
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration
Baseline characteristics by cohort
| Measure |
Ranibizumab 0.5mg Intravitreal Injection
n=47 Participants
Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg.
|
Aflibercept 2.0mg Intravitreal Injection
n=53 Participants
Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Age, Continuous
|
76.3 years
n=99 Participants
|
80.6 years
n=107 Participants
|
78.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=99 Participants
|
53 participants
n=107 Participants
|
100 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)
Outcome measures
| Measure |
Ranibizumab 0.5mg Intravitreal Injection
n=47 Participants
Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg.
|
Aflibercept 2.0mg Intravitreal Injection
n=53 Participants
Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg.
|
|---|---|---|
|
Evidence of Anterior Chamber Inflammation
Inflammation at visit 1
|
1 participants
|
10 participants
|
|
Evidence of Anterior Chamber Inflammation
Inflammation at visit 2
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)Pain score rated on an 11 point numerical rating from 0-10 ( 0 = no pain, and 10 = worst possible pain) administered to each patient verbally at visit #1 and visit #2. The data below shows number of patients with pain score 1 or greater in each group.
Outcome measures
| Measure |
Ranibizumab 0.5mg Intravitreal Injection
n=47 Participants
Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg.
|
Aflibercept 2.0mg Intravitreal Injection
n=53 Participants
Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg.
|
|---|---|---|
|
Patients With Post Injection Pain Score of One or Higher on Pain Scale
Subjects with pain score 1 or higher at visit 1
|
7 participants
|
9 participants
|
|
Patients With Post Injection Pain Score of One or Higher on Pain Scale
Subjects with pain score 1 or higher at visit 2
|
0 participants
|
1 participants
|
Adverse Events
Ranibizumab 0.5mg Intravitreal Injection
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Aflibercept 2.0mg Intravitreal Injection
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ranibizumab 0.5mg Intravitreal Injection
n=47 participants at risk
Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg.
|
Aflibercept 2.0mg Intravitreal Injection
n=53 participants at risk
Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg.
|
|---|---|---|
|
Eye disorders
Anterior chamber inflammation at Visit 1
|
2.1%
1/47 • Number of events 1
|
18.9%
10/53 • Number of events 10
|
|
Eye disorders
Anterior chamber inflammation at Visit 2
|
0.00%
0/47
|
1.9%
1/53 • Number of events 1
|
|
Eye disorders
Vitreous inflammation at Visit 1
|
0.00%
0/47
|
7.5%
4/53 • Number of events 4
|
|
Eye disorders
Vitreous inflammation at Visit 2
|
0.00%
0/47
|
1.9%
1/53 • Number of events 1
|
Additional Information
Arshad Khanani M.D., Vitreo-Retinal Diseases and Surgery
Sierra Eye Associates
Phone: 775-329-0286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place