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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02543229 | Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™ in Patients With Wet AMD | PHASE1 | COMPLETED | 51 | — | — | Jul 1, 2015 | Sep 1, 2017 | Nov 6, 2017 | 14 | United States |
Subject incidences of ophthalmic and systemic Adverse Events during study and follow-up period
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose escalation - Cohort 1 | EXPERIMENTAL | Dose Level 1 of OPT-302 in combination with Lucentis™ |
| Part 1 Dose escalation - Cohort 2 | EXPERIMENTAL | Dose Level 2 of OPT-302 in combination with Lucentis™ |
| Part 1 Dose escalation - Cohort 3 | EXPERIMENTAL | Dose Level 3 of OPT-302 in combination with Lucentis™ |
| Part 1 Dose escalation - Cohort 4 | EXPERIMENTAL | Dose Level 3 of OPT-302 monotherapy |
| Part 2 Dose expansion - Cohort 5 | EXPERIMENTAL | OPT-302 (at Maximum Tolerated Dose \[MTD\] or highest dose tested in Part 1) in combination with Lucentis™ |
| Part 2 Dose expansion - Cohort 6 | EXPERIMENTAL | OPT-302 (at MTD or highest dose tested in Part 1) monotherapy |
| Name | Type | Description |
|---|---|---|
| OPT-302 | DRUG | OPT-302 will be administered by intravitreal injection once every month for 3 months |
| Lucentis™ | DRUG | Lucentis™ (0.5 mg) will be administered by intravitreal injection once every month for 3 months |
Inclusion Criteria: * Able and willing to provide written informed consent * Age ≥ 50 years of either gender * Active CNV lesions secondary to AMD (i.e., subretinal or intraretinal fluid on SD-OCT and / or leakage on fluorescein angiography) * Either no previous treatment in the study eye with IVT ...