Trial Outcomes & Findings for ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD) (NCT NCT03362190)
NCT ID: NCT03362190
Last Updated: 2025-06-10
Results Overview
Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
6 months
Results posted on
2025-06-10
Participant Flow
Participant milestones
| Measure |
Cohort 1
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
|
Cohort 2
Monthly administration of Zimura 2mg + Lucentis 0.5 mg administered (given on the same day)
|
Cohort 3
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5mg (Total: 6 doses of Zimura \& 3 doses Lucentis)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
22
|
22
|
|
Overall Study
COMPLETED
|
10
|
10
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
|
Cohort 2
Monthly administration of Zimura 2mg + Lucentis 0.5 mg administered (given on the same day)
|
Cohort 3
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5mg (Total: 6 doses of Zimura \& 3 doses Lucentis)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
Baseline characteristics by cohort
| Measure |
Cohort 1
n=10 Participants
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
|
Cohort 2
n=10 Participants
Monthly administration of Zimura 2mg + Lucentis 0.5 mg (given on the same day)
|
Cohort 3
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Lucentis 0.5mg + Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis)
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Age, Continuous
|
73.7 years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
77.9 years
STANDARD_DEVIATION 6.62 • n=7 Participants
|
74.1 years
STANDARD_DEVIATION 7.41 • n=5 Participants
|
78.1 years
STANDARD_DEVIATION 7.40 • n=4 Participants
|
76.0 years
STANDARD_DEVIATION 8.07 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
2 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
17 participants
n=4 Participants
|
45 participants
n=21 Participants
|
|
ETDRS Visual Acuity -Study Eye
|
53.9 number of letters read
STANDARD_DEVIATION 9.0 • n=5 Participants
|
51.5 number of letters read
STANDARD_DEVIATION 5.4 • n=7 Participants
|
52.5 number of letters read
STANDARD_DEVIATION 9.4 • n=5 Participants
|
53.2 number of letters read
STANDARD_DEVIATION 9.9 • n=4 Participants
|
52.8 number of letters read
STANDARD_DEVIATION 8.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Safety Population
Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
|
Cohort 2
n=10 Participants
Monthly administration of Zimura 2mg + Lucentis 0.5mg (given on the same day)
|
Cohort 3
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly adminstration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5 mg (Total: 6 doses Zimura \& 3 doses of Lucentis)
|
|---|---|---|---|---|
|
Systemic Adverse Events
All causalities
|
6 Participants
|
5 Participants
|
5 Participants
|
11 Participants
|
|
Systemic Adverse Events
Related to study drugs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Safety Population
Number of participants with ophthalmic Adverse Events (with calculated percentage)
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
|
Cohort 2
n=10 Participants
Monthly administration of Zimura 2mg + Lucentis 0.5mg (given on the same day)
|
Cohort 3
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly adminstration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5 mg (Total: 6 doses Zimura \& 3 doses of Lucentis)
|
|---|---|---|---|---|
|
Ophthalmic Adverse Events
Participants with all causality events in the fellow eye
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Ophthalmic Adverse Events
Participants with all causality events in the study eye
|
8 Participants
|
4 Participants
|
11 Participants
|
15 Participants
|
|
Ophthalmic Adverse Events
Participants with event related to injection procedure in the study eye
|
8 Participants
|
4 Participants
|
10 Participants
|
12 Participants
|
|
Ophthalmic Adverse Events
Participants with event related to injection procedure in the fellow eye
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ophthalmic Adverse Events
Participants with event related to study drugs in the study eye
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ophthalmic Adverse Events
Participants with event related to study drugs in the fellow eye
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsNumber of patients with a change on their Month 6 ECG when compared to their baseline ECG
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
|
Cohort 2
n=10 Participants
Monthly administration of Zimura 2mg + Lucentis 0.5mg (given on the same day)
|
Cohort 3
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly adminstration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5 mg (Total: 6 doses Zimura \& 3 doses of Lucentis)
|
|---|---|---|---|---|
|
Change From Baseline - ECG
Not Clinically Signigicant Change
|
3 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
|
Change From Baseline - ECG
No Change
|
7 Participants
|
5 Participants
|
18 Participants
|
12 Participants
|
|
Change From Baseline - ECG
Clinically Significant Change
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline - ECG
Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: safety population
Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
|
Cohort 2
n=10 Participants
Monthly administration of Zimura 2mg + Lucentis 0.5mg (given on the same day)
|
Cohort 3
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly adminstration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5 mg (Total: 6 doses Zimura \& 3 doses of Lucentis)
|
|---|---|---|---|---|
|
Mean Change From Baseline - Study Eye ETDRS Visual Acuity
|
9.0 number of letters read
Standard Deviation 11.0
|
10.2 number of letters read
Standard Deviation 18.7
|
10.7 number of letters read
Standard Deviation 10.3
|
9.9 number of letters read
Standard Deviation 8.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: safety population
Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
|
Cohort 2
n=10 Participants
Monthly administration of Zimura 2mg + Lucentis 0.5mg (given on the same day)
|
Cohort 3
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
n=22 Participants
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly adminstration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5 mg (Total: 6 doses Zimura \& 3 doses of Lucentis)
|
|---|---|---|---|---|
|
Mean Change From Baseline - Vital Signs
Systolic blood pressure (mm Hg)
|
-12.0 mm Hg
Standard Deviation 15.04
|
0.7 mm Hg
Standard Deviation 8.92
|
-1.9 mm Hg
Standard Deviation 14.92
|
-5.8 mm Hg
Standard Deviation 18.24
|
|
Mean Change From Baseline - Vital Signs
Diastolic blood pressure (mm Hg)
|
-3.2 mm Hg
Standard Deviation 7.93
|
-7.9 mm Hg
Standard Deviation 12.32
|
-4.7 mm Hg
Standard Deviation 11.83
|
-0.4 mm Hg
Standard Deviation 8.24
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 4
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=10 participants at risk
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4 mg
|
Cohort 2
n=10 participants at risk
Monthly administration of Zimura 2 mg + Lucentis 0.5 mg (given on the same day)
|
Cohort 3
n=22 participants at risk
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
n=22 participants at risk
Zimura 2 mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2 mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2 mg + Lucentis 0.5 mg (Total: 6 doses of Zimura \& 3 doses Lucentis)
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Eye disorders
Retinal detachment
|
0.00%
0/10 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Cohort 1
n=10 participants at risk
Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4 mg
|
Cohort 2
n=10 participants at risk
Monthly administration of Zimura 2 mg + Lucentis 0.5 mg (given on the same day)
|
Cohort 3
n=22 participants at risk
Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
|
Cohort 4
n=22 participants at risk
Zimura 2 mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2 mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura \& 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2 mg + Lucentis 0.5 mg (Total: 6 doses of Zimura \& 3 doses Lucentis)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 2 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
2/10 • Number of events 2 • 6 months
|
0.00%
0/10 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
2/10 • Number of events 2 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Injury, poisoning and procedural complications
Laceration
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
Eye disorders
Conjunctival haemorrhage
|
60.0%
6/10 • Number of events 14 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
22.7%
5/22 • Number of events 6 • 6 months
|
27.3%
6/22 • Number of events 12 • 6 months
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/10 • 6 months
|
0.00%
0/10 • 6 months
|
13.6%
3/22 • Number of events 3 • 6 months
|
13.6%
3/22 • Number of events 3 • 6 months
|
|
Eye disorders
Punctate keratitis
|
20.0%
2/10 • Number of events 2 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
4.5%
1/22 • Number of events 2 • 6 months
|
|
Eye disorders
Conjunctival hyperaemia
|
10.0%
1/10 • Number of events 1 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
9.1%
2/22 • Number of events 5 • 6 months
|
|
Eye disorders
Eye pain
|
10.0%
1/10 • Number of events 3 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
13.6%
3/22 • Number of events 6 • 6 months
|
|
Eye disorders
Corneal oedema
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
9.1%
2/22 • Number of events 3 • 6 months
|
|
Eye disorders
Ocular discomfort
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
9.1%
2/22 • Number of events 2 • 6 months
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/10 • 6 months
|
0.00%
0/10 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
9.1%
2/22 • Number of events 2 • 6 months
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
9.1%
2/22 • Number of events 2 • 6 months
|
0.00%
0/22 • 6 months
|
|
Eye disorders
Lacrimation increased
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Eye disorders
Visual impairment
|
0.00%
0/10 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
9.1%
2/22 • Number of events 2 • 6 months
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 3 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Eye disorders
Subretinal fibrosis
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Eye disorders
Vitreous opacities
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
10.0%
1/10 • Number of events 1 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Investigations
Intraocular pressure increased
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • Number of events 2 • 6 months
|
|
Eye disorders
cataract
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Eye disorders
Neovascular age-related macular degeneration
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
Additional Information
Hersh Patel, OD / Zimura Medical Director
IVERIC bio, Inc
Phone: 609-474-6755
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution/PI agrees not to individually publish the results of the Study without IVERIC bio's prior written consent. Institution/PI may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of IVERIC bio.
- Publication restrictions are in place
Restriction type: OTHER