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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05769153 | Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD) | PHASE1 | ACTIVE NOT_RECRUITING | 139 | — | — | Dec 6, 2023 | Oct 1, 2027 | May 26, 2026 | 42 | United States |
Visual acuity will be measured after manifest refraction using Early Treatment of Diabetic Retinopathy Study (ETDRS) letter charts in a 4-meter lane under standard illumination. Best corrected visual acuity (BCVA) will be recorded as the number of letters read correctly. The difference between the average across Weeks 44 and 48, and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (Stage 1) | EXPERIMENTAL | One intravitreal (IVT) injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR lower dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria. |
| Cohort 2 (Stage 1) | EXPERIMENTAL | One IVT injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR higher dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria. |
| AR-14034 SR one injection (Stage 2) | EXPERIMENTAL | One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR at Week 2. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections. |
| AR-14034 SR two injections (Stage 2) | EXPERIMENTAL | One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with IVT insertions of AR-14034 SR at Week 2 and Week 6. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections. |
| Aflibercept (Stage 2) | ACTIVE_COMPARATOR | One IVT injection of aflibercept 2 mg at Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections. |
| Name | Type | Description |
|---|---|---|
| AR-14034 SR implant lower dose | DRUG | AR-14034 SR administered as an intravitreal implant |
| AR-14034 SR implant higher dose | DRUG | AR-14034 SR administered as an intravitreal implant |
| AR-14034 SR implant | DRUG | AR-14034 SR administered as an intravitreal implant |
| Aflibercept Injection | DRUG | Aflibercept administered as a 2 milligram (mg) intravitreal injection |
| Sham procedure | DRUG | Needleless syringe used to simulate an intravitreal injection |
Key Inclusion Criteria \[Stage 1 and Stage 2\]: * Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD); * Best corrected visual acuity (BCVA) between 80 and 35 letters (20/25 to 20/200 Snellen equivalent) in the study eye; * BCVA greate...