ADVM-022 Intravitreal Gene Therapy for Wet AMD

Launched by ADVERUM BIOTECHNOLOGIES, INC. · Nov 19, 2018

Keywords

ClinConnect Summary

This open-label, multicenter, dose-ranging study will evaluate 2 dose levels in up to 30 subjects (15 per dose) with active choroidal neovascularization (CNV) secondary to AMD. Subjects who are under active anti-VEGF treatment and have demonstrated a meaningful response to anti-VEGF therapy will be considered for participation in this study. The primary endpoint for this study is safety and tolerability of ADVM-022. All subjects will continue to be assessed for 104 weeks following treatment with ADVM-022.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 50
• • Diagnosis of neovascular (wet) AMD
• • BCVA ETDRS Snellen equivalent between ≤20/32 and ≥20/320 for each cohort
• • Subjects must be under active anti-VEGF treatment for wAMD and received a minimum of 2 injections within 4 months prior to screening
• • Demonstrated a meaningful response to anti-VEGF therapy
• • Willing and able to provide consent
• Exclusion Criteria:
• • History of retinal disease in the study eye other than wet AMD
• • Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye, or any condition preventing visual acuity improvement
• • History of retinal detachment (with or without repair) in the study eye
• • History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
• • Uncontrolled glaucoma in the study eye
• • Any prior treatment with photodynamic therapy or retinal laser for the treatment of wet AMD and any previous therapeutic radiation in the region of the study eye
• • Any previous intraocular or periocular surgery on the study eye within 6 months
• • Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
• • Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg