|
Cohort1: dose level 1
|
| Administration route |
intravitreal injection |
| Dosage |
1 mg, monthly up to 18 months |
| Pts |
26 |
| Age |
Adult, Older_Adult |
| Adverse reactions |
1/26(All-cause mortality); 3/26(Cardiac disorders; Gastrointestinal disorders; Musculoskeletal and connective tissue disorders; Nervous system disorders) |
| References |
PMID:
32882310 |
NCT02686658
|
|
|
Cohort2: dose level 2
|
| Administration route |
intravitreal injection |
| Dosage |
2 mg, monthly up to 18 months |
| Pts |
25 |
| Age |
Adult, Older_Adult |
| Adverse reactions |
4/25(Gastrointestinal disorders; Hepatobiliary disorders; Infections and infestations; Injury, poisoning and procedural complications; Nervous system disorders; Respiratory, thoracic and mediastinal disorders) |
| References |
PMID:
32882310 |
NCT02686658
|
|
|
Cohort3: dose level 2_Sham
|
| Administration route |
intravitreal injection |
| Dosage |
2 mg + Sham, monthly up to 18 months |
| Pts |
42 |
| Age |
Adult, Older_Adult |
| Adverse reactions |
1/42(All-cause mortality); 8/42(Cardiac disorders; Eye disorders; General disorders; Infections and infestations; Injury, poisoning and procedural complications; Neoplasms benign, malignant and unspecified, incl cysts and polyps; Nervous system disorders) |
| References |
PMID:
32882310 |
NCT02686658
|
|
|
Cohort4: dose level 3
|
| Administration route |
intravitreal injection |
| Dosage |
4 mg, monthly up to 18 months |
| Pts |
83 |
| Age |
Adult, Older_Adult |
| Adverse reactions |
1/83(All-cause mortality); 21/83(Blood and lymphatic system disorders; Cardiac disorders; Eye disorders; Gastrointestinal disorders; Hepatobiliary disorders; Infections and infestations; Injury, poisoning and procedural complications; Neoplasms benign, malignant and unspecified, incl cysts and polyps; Nervous system disorders; Respiratory, thoracic and mediastinal disorders) |
| References |
PMID:
32882310 |
NCT02686658
|
|
|
Cohort5: Sham
|
| Administration route |
intravitreal injection |
| Dosage |
Sham, monthly up to 18 months |
| Pts |
110 |
| Age |
Adult, Older_Adult |
| Adverse reactions |
1/110(All-cause mortality); 28/110(Cardiac disorders; Gastrointestinal disorders; Hepatobiliary disorders; Infections and infestations; Injury, poisoning and procedural complications; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified, incl cysts and polyps; Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders) |
| References |
PMID:
32882310 |
NCT02686658
|
|