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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04246866 | First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration | PHASE1 | COMPLETED | 12 | — | — | Dec 19, 2019 | Oct 21, 2020 | Feb 11, 2021 | 12 | United States |
| Arm | Type | Description |
|---|---|---|
| Dose 1 | EXPERIMENTAL | A single dose of GEM103 will be administered via intravitreal injection. This arm will be the lowest dose of GEM103 |
| Dose 2 | EXPERIMENTAL | A single dose of GEM103 will be administered via intravitreal injection. This arm will be the medium dose of GEM103 |
| Dose 3 | EXPERIMENTAL | A single dose of GEM103 will be administered via intravitreal injection. This arm will be a higher dose of GEM103 |
| Dose 4 | EXPERIMENTAL | A single dose of GEM103 will be administered via intravitreal injection. This arm will be the highest (extension) dose of GEM103 |
| Name | Type | Description |
|---|---|---|
| GEM103 | BIOLOGICAL | GEM103 |
Inclusion Criteria: 1. At least 50 years old at the time of signed informed consent 2. Able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment and provide informed consent prior to initiation of any study procedure 3. Best corrected visual acuity (BCVA...