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Also known as AR-14034 SR implant lower dose
AR-14034 lower dose · 1 trial · 1 indication
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...
AR-14034 lower dose is an investigational small molecule being developed for the treatment of neovascular Age-related Macular Degeneration (nAMD), a chronic eye disease that causes blurred vision or blindness due to abnormal blood vessel growth under the macula. It is administered as a sustained-release (SR) implant.
AR-14034 lower dose is being developed by Alcon Inc. (ticker: ALC), a global medical device and pharmaceutical company specializing in eye care. The drug is currently in Phase 1 clinical development for neovascular Age-related Macular Degeneration (nAMD).
AR-14034 lower dose is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied in a Phase 1 trial for neovascular Age-related Macular Degeneration (nAMD), with the trial currently active but not recruiting participants.
AR-14034 lower dose is being evaluated in a Phase 1 clinical trial with the identifier NCT05769153, titled 'Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD).' The trial is active but not recruiting, with an enrollment of 139 participants in the United States.
Yes, AR-14034 lower dose is also known as AR-14034 SR implant lower dose. The 'SR' refers to the sustained-release formulation of the implant, which is designed to deliver the drug over an extended period for the treatment of neovascular Age-related Macular Degeneration (nAMD).