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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01175395 | 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) | PHASE1 | COMPLETED | 10 | — | — | Sep 1, 2010 | Jan 1, 2013 | Oct 20, 2014 | 1 | United States |
The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis. The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit.
| Arm | Type | Description |
|---|---|---|
| IBI-20089/Lucentis | EXPERIMENTAL | Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis |
| Name | Type | Description |
|---|---|---|
| IBI-20089/Lucentis | DRUG | Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results. |
Inclusion Criteria: 1. Male or Female subjects, 55 years of age and older. 2. Diagnosis of active, subfoveal choroidal neovascular membranes (CNVM) due to age related macular degeneration (AMD) 3. Visual acuity from 20/25 to 20/400 in the study eye. Exclusion Criteria: 1. Subjects who have receiv...