| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02515942 | CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA) | PHASE2 | COMPLETED | 114 | — | — | Sep 25, 2015 | Dec 1, 2017 | May 30, 2019 | - | — |
A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted.
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.
| Arm | Type | Description |
|---|---|---|
| CLG561 | EXPERIMENTAL | CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections |
| CLG561+LFG316 | EXPERIMENTAL | CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections |
| Sham Injection | SHAM_COMPARATOR | One sham injection every 28 days for total of 12 sham injections |
| Name | Type | Description |
|---|---|---|
| CLG561 | DRUG | - |
| LFG316 | DRUG | - |
| Sham injection | DRUG | Empty syringe (without a needle) placed against the eye |
Inclusion Criteria: * Sign written informed consent form; * Geographic atrophy in both eyes; * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Pregnant or lactating women and women of child-bearing potential; * Any medical condition (systemic or ophthalmic) that may p...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | — | Pegcetacoplan |