Adverum Biotechnologies, Inc is recruiting patients for the clinical trial of Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration.
Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-12 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product, being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
This Phase 2, multi-center, randomized, double-masked, parallel group study is designed to evaluate the safety, tolerability, and efficacy of a single IVT injection of ADVM-022 at one of two dose levels (2 × 10^11 vg/eye [2E11] or 6 × 10^10 vg/eye [6E10]) accompanied by one of four prophylactic corticosteroid treatment regimens. Approximately, 72 anti-VEGF treatment-experienced study participants meeting the eligibility criteria will be randomized equally between the 2E11 vg/eye and 6E10 vg/eye ADVM-022 doses across four prophylactic corticosteroid regimens, and only one eye per study participant will be selected as the study eye. Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.
The researchers plan that August 23, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in February 2024.
Among primary outcome measures are the Mean change in best corrected visual acuity (BCVA) from Baseline and BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS).
The study will take place in several locations in the United States, and will include the following popoulation: male or female participants ≥ 50 years who demonstrated a meaningful response to anti-VEGF therapy and have current evidence of active primary or recurrent sub-foveal choroidal neovascularization (CNV) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Subjects must be under active anti-VEGF treatment for wet AMD and received a minimum of 2 injections within 4 months prior to screening. For the complete list of the inclusion and exclusion criteria, as well as for locations and contact details please consult the complete study profile here: https://ichgcp.net/clinical-trials-registry/NCT05536973.