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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05891548 | Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration | PHASE2 | COMPLETED | 60 | — | — | May 31, 2023 | Aug 20, 2024 | Jul 25, 2025 | 32 | United States |
| NCT04626128 | Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD | PHASE1 | COMPLETED | 27 | — | — | Dec 15, 2020 | Oct 13, 2022 | Sep 18, 2023 | 11 | United States |
Best Corrected Visual Acuity (BCVA) letter score measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting test distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable). An increase in BCVA letter score from baseline indicates an improvement in visual acuity.
Number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.
Number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.
| Arm | Type | Description |
|---|---|---|
| 1.0 mg CLS-AX | EXPERIMENTAL | Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX |
| Aflibercept | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept (2 mg in 0.05 mL) |
| Cohort 1 (Low Dose) | EXPERIMENTAL | Subjects will receive a low dose of 0.03 mg CLS-AX |
| Cohort 2 (Low-mid Dose) | EXPERIMENTAL | Subjects will receive a low-mid dose of 0.10 mg CLS-AX |
| Cohort 3 (High-mid Dose) | EXPERIMENTAL | Subjects will receive a high-mid dose of 0.50 mg CLS-AX |
| Cohort 4 (High Dose) | EXPERIMENTAL | Subjects will receive a high-mid dose of 1.0 mg CLS-AX |
| Name | Type | Description |
|---|---|---|
| CLS-AX | DRUG | CLS-AX will be administered by suprachoroidal injection into the study eye on Day 1 and then every 12 to 24 weeks as determined by protocol-defined disease activity criteria. |
| Aflibercept | DRUG | Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W). |
| Anti-VEGF | DRUG | Standard of care therapy used to block vascular endothelial growth factor |
Key Inclusion Criteria: * Diagnosis of neovascular age-related macular degeneration (nAMD) in the study eye within 36 months of Visit 1. * Subfoveal choroidal neovascularization (CNV) secondary to nAMD of any lesion type in the study eye that shows total lesion area ≤30 mm2, CNV component area of ≥...