Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01242254 | A Study Assessing the Safety and Efficacy of Multiple Intravitreal KH902 in Patients With CNV Due to AMD | PHASE1 | COMPLETED | 36 | — | — | Aug 1, 2009 | Feb 1, 2011 | Mar 27, 2014 | 3 | China |
To evaluate the safety of multiple intravitreal injection of KH902 of each group.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Patients will receive an intravitreal injection of KH902 0.5mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52 |
| Group B | EXPERIMENTAL | Patients will receive an intravitreal injection of KH902 2.0mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52 |
| Name | Type | Description |
|---|---|---|
| Intravitreal injection of KH902 | BIOLOGICAL | 0.5 mg 2.0 mg once per 4 weeks during fixed dosing phase once as needed during extended treatment phase |
Inclusion Criteria: * Signed the Informed Consent Form by patients or legal representative; * Men and women ≥ 45 years of age; * Active primary or recurrent lesions with CNV secondary to neovascular AMD; * Total lesion size ≤ 12 disc areas in either eye; * BCVA of the study eyes \< 69 letters and t...