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Cohort1: Zimura_dose level 1
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| Administration route |
intravitreal injection |
| Dosage |
Zimura, 4 mg; Lucentis, 0.5 mg |
| Pts |
10 |
| Age |
Adult, Older_Adult |
| Outcome |
Systemic Adverse Events:All causalities Measure Type: Count of Participants:6 60.0%; Related to study drugs:0 0.0%|Ophthalmic Adverse Events:Participants with all causality events in the fellow eye Measure Type: Count of Participants:1 10.0%; Participants with all causality events in the study eye:8 80.0%; Participants with event related to injection procedure in the study eye:8 80.0%; Participants with event related to injection procedure in the fellow eye:0 0.0%; Participants with event related to study drugs in the study eye:0 0.0%; Participants with event related to study drugs in the fellow eye:0 0.0% |
| Adverse reactions |
No serious clinical adverse events |
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Cohort2: Zimura_dose level 2
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| Administration route |
intravitreal injection |
| Dosage |
Zimura, 2 mg; Lucentis, 0.5 mg |
| Pts |
10 |
| Age |
Adult, Older_Adult |
| Outcome |
Systemic Adverse Events:All causalities Measure Type: Count of Participants:5 50.0%; Related to study drugs:0 0.0%|Ophthalmic Adverse Events:Participants with all causality events in the fellow eye Measure Type: Count of Participants:1 10.0%; Participants with all causality events in the study eye:4 40.0%; Participants with event related to injection procedure in the study eye:4 40.0%; Participants with event related to injection procedure in the fellow eye:0 0.0%; Participants with event related to study drugs in the study eye:0 0.0%; Participants with event related to study drugs in the fellow eye:0 0.0% |
| Adverse reactions |
1/10(Metabolism and nutrition disorders) |
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Cohort3: Zimura_dose level 2_9 doses
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| Administration route |
intravitreal injection |
| Dosage |
Induction Phase: Zimura, 2mg, 6 doses; Lucentis 0.5 mg, 3 doses. Maintenance Phase: Zimura 2mg, 3 doses, Monthly; Lucentis 0.5 mg, 3 doses, Monthly |
| Pts |
22 |
| Age |
Adult, Older_Adult |
| Outcome |
Systemic Adverse Events:All causalities Measure Type: Count of Participants:5 22.7%; Related to study drugs:0 0.0%|Ophthalmic Adverse Events:Participants with all causality events in the fellow eye Measure Type: Count of Participants:0 0.0%; Participants with all causality events in the study eye:11 50.0%; Participants with event related to injection procedure in the study eye:10 45.5%; Participants with event related to injection procedure in the fellow eye:0 0.0%; Participants with event related to study drugs in the study eye:0 0.0%; Participants with event related to study drugs in the fellow eye:0 0.0% |
| Adverse reactions |
No serious clinical adverse events |
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Cohort4: Zimura_dose level 2_12 doses
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| Administration route |
intravitreal injection |
| Dosage |
Induction Phase: Zimura, 2mg, 6 doses; Lucentis 0.5 mg, 3 doses. Maintenance Phase: Zimura 2mg, 6 doses, Monthly; Lucentis 0.5 mg, 3 doses, Monthly |
| Pts |
22 |
| Age |
Adult, Older_Adult |
| Outcome |
Systemic Adverse Events:All causalities Measure Type: Count of Participants:11 50.0%; Related to study drugs:0 0.0%|Ophthalmic Adverse Events:Participants with all causality events in the fellow eye Measure Type: Count of Participants:2 9.1%; Participants with all causality events in the study eye:15 68.2%; Participants with event related to injection procedure in the study eye:12 54.5%; Participants with event related to injection procedure in the fellow eye:0 0.0%; Participants with event related to study drugs in the study eye:0 0.0%; Participants with event related to study drugs in the fellow eye:0 0.0% |
| Adverse reactions |
2/22(Eye disorders; Respiratory, thoracic and mediastinal disorders) |
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