The purpose of this study is to evaluate safety, effectiveness and durability of a gene therapy called Ixo-vec (Ixoberogene soroparvovec) when administered to the contralateral (second) eye of adult participants (≥ 50 years of age) who have been diagnosed with bilateral neovascular (wet) age related macular degeneration (nAMD). The study will enroll adults with nAMD in both eyes, including participants who previously received Ixo-vec treatment in one (initial) eye and/or participants who will receive Ixo-vec treatment for the first time. This study focuses on how the treatment works when both eyes are treated at different times and how effective and long-lasting Ixo-vec treatment is in the second (contralateral) eye. Participants will receive a single administration of Ixo-vec in the contralateral eye and will be followed for approximately 5 years to evaluate safety, efficacy and durability of contralateral treatment. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy. The study is intended to provide additional information on the safety, tolerability, and use of Ixo-vec in bilateral treatment.
This is a Phase 2, single-arm, open-label, multi-center study in participants who are ≥ 50 years old with a diagnosis of bilateral choroidal neovascularization (CNV) secondary to neovascular (wet) age related macular degeneration (nAMD). This study is designed to evaluate the safety, tolerability, and efficacy of Ixo-vec dosing in the contralateral (second) eye. The study includes participants who have previously received Ixo-vec in one eye in a prior clinical study, as well as Ixo-vec-naïve participants eligible for sequential bilateral administration. The study will evaluate the use of Ixo-vec when both eyes are treated at different time points. Neovascular AMD is a progressive retinal disease characterized by the growth of abnormal blood vessels originating from the choroid, which can lead to vision loss. Current standard of care includes repeated intravitreal (IVT) administration of anti-vascular endothelial growth factor (anti-VEGF) therapies. Ixo-vec (also known as Ixoberogene soroparvovec, ADVM-022 or AAV.7m8-aflibercept) is an adeno-associated virus (AAV)-based gene therapy designed to enable sustained intraocular expression of an anti-VEGF protein following a single IVT administration. The primary objective of this study is to assess the safety and tolerability of Ixo-vec administered to the contralateral eye. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy over time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Ixo-vec (6 × 10\^10 vg/eye) will be administered intravitreally
Adverum site 126
Phoenix, Arizona, United States
RECRUITINGAdverum site 109
Bakersfield, California, United States
RECRUITINGAdverum site 169
Fullerton, California, United States
RECRUITINGAdverum site 124
Deerfield Beach, Florida, United States
RECRUITINGAdverum site 176
Fort Lauderdale, Florida, United States
RECRUITINGAdverum site 168
Jacksonville, Florida, United States
RECRUITINGAdverum site 149
‘Aiea, Hawaii, United States
RECRUITINGAdverum site 179
Lemont, Illinois, United States
RECRUITINGAdverum site 171
Teaneck, New Jersey, United States
RECRUITINGAdverum site 122
West Columbia, South Carolina, United States
RECRUITING...and 2 more locations
Incidence of ocular adverse events (AEs)
The number of participants who experience an ocular adverse event will be summarized.
Time frame: Baseline through Week 28
Incidence of ocular serious adverse events (SAEs).
The number of participants who experience ocular serious adverse event will be summarized.
Time frame: Baseline through Week 28
Incidence of non-ocular serious adverse events (SAEs).
The number of participants who experience non-ocular serious adverse event will be summarized.
Time frame: Baseline through Week 28
Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28.
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
Time frame: Baseline through Week 28
Mean change from baseline in central subfield thickness (CST) over time through Week 28.
CST as measured by spectral domain optical coherence tomography (SD-OCT).
Time frame: Baseline through Week 28
Mean number of supplemental aflibercept IVT injections received from Week 4 through Week 28
Efficacy will be measured by the number of supplemental aflibercept injections post Ixo-vec administration.
Time frame: Week 4 through Week 28
Percentage of participants who are supplemental aflibercept injection-free through Week 28.
Efficacy will be measured as the percentage of participants who will not received supplemental aflibercept injections post Ixo-vec administration.
Time frame: Baseline through Week 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.