Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]

Study Overview
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Brief Summary
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ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).

Detailed Description
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ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice. ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD). To evaluate potential long-term outcomes of ADVM-022, the OPTIC-EXT will follow subjects previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 [OPTIC] (NCT03748784)). Subjects will roll over from the OPTIC parent study and will be followed for 3 additional years, following completion of the preceding 2-year assessment period in the OPTIC parent study. There is no investigational treatment administered in this study.

Official Title
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A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension

Conditions
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Wet Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Biological: ADVM-022


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who received a single dose of ADVM-022 at any dose in the OPTIC study Willing and able to provide informed consent Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Subjects with wet AMD who received any dose of ADVM-022 in a prior clinical study. | Biological: ADVM-022<br>* Long term follow-up of subjects that received ADVM-022<br>* Other names: AAV.7m8-aflibercept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, severity and incidence of ocular and systemic adverse events (AEs). | Type, severity and incidence of ocular and systemic adverse events | 156 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best corrected visual acuity (BCVA) from baseline, over time | Change in best corrected visual acuity (BCVA) from baseline, over time | 156 weeks | 
| Mean change in central subfield thickness (CST) and macular volume from baseline, over time | Mean change in central subfield thickness (CST) and macular volume from baseline, over time | 156 weeks | 
| Percentage of subjects requiring supplemental aflibercept over time | Percentage of subjects requiring supplemental aflibercept over time | 156 weeks | 
| Mean number of supplemental aflibercept injections over time | Mean number of supplemental aflibercept injections over time | 156 weeks | 
| Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time | Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time | 156 weeks | 
| Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time | Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time | 156 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choroidal Neovascularization, ADVM-022, OPTIC Study, CNV, ADVM-022-01, ADVM-022-07, AAV.7m8, Anti-VEGF therapy, Blindness, Gene therapy, Aflibercept (Eylea), Age-Related Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, AAV Vector, Adverum, wAMD, AMD, wet AMD, nAMD, OPTIC Extension, OPTIC-EXT, Long-term Follow Up, Long-term Extension