A Phase 1/2 Two-Stage Dose Escalation and Randomized Parallel-Group Study to Evaluate the Safety, Preliminary Treatment Effects, and Durability of AR-14034 Sustained Release Implant Compared to Intravitreal Anti-Vascular Endothelial Growth Factor Treatment in Participants With Neovascular Age-Related Macular Degeneration (NOVA-1)

NCT05769153 Phase 1/Phase 2 RECRUITING

The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).

Details

Lead sponsor	Alcon Research
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	140
Start date	2023-12-06
Completion	2027-10

Conditions

• Neovascular Age-related Macular Degeneration (nAMD)

Interventions

• AR-14034 SR implant lower dose
• AR-14034 SR implant higher dose
• AR-14034 SR implant
• Aflibercept Injection
• Sham procedure

Primary outcomes

• Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2) — Baseline, Week 44, Week 48
  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.

Countries

United States