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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01226628 | A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration | PHASE1 | COMPLETED | 39 | — | — | Oct 21, 2010 | May 31, 2017 | Aug 8, 2017 | 2 | United States |
This number will be summarized descriptively for treated and fellow eyes within each dose level included in Phase 1 and Phase 2a portions of the study
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Phase 1: 3 patients will receive 60,000 human umbilical tissue-derived cells (hUTC) |
| Cohort B | EXPERIMENTAL | Phase 1: 3 patients will receive 120,000 hUTC |
| Cohort C | EXPERIMENTAL | Phase 1: 3 patients will receive 300,000 hUTC |
| Cohort D | EXPERIMENTAL | Phase 1: 3 patients will receive 560,000 hUTC |
| Cohort E | EXPERIMENTAL | Phase 1: 6 patients will receive 300,000 hUTC |
| Cohort F | EXPERIMENTAL | Phase 1: 6 patients will receive either 60,000 or 300,000 hUTC |
| Cohort G | EXPERIMENTAL | Phase 1: 6 patients will receive either 60,000 or 300,000 hUTC |
| Phase 2a | EXPERIMENTAL | Up to 38 patients will receive one of two optimal doses as selected from the Phase 1 portion of the study |
| Name | Type | Description |
|---|---|---|
| CNTO 2476 | BIOLOGICAL | - |
| iTrack Model 275 micro catheter | PROCEDURE | CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment. During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula. |
Inclusion Criteria: * Women must be incapable of childbearing * Patient must be a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures * Confirmed diagnosis of bilatera...