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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 participants with neovascular, or exudative (wet), age-related macular degeneration (nAMD).
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 participants with neovascular or exudative (wet), age-related macular degeneration (nAMD) previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 [OPTIC] - NCT03748784). There is no investigational treatment administered in this study.
In Part 1 of the OPTIC-EXT study participants will roll over from the OPTIC parent study and will be followed for 3 additional years (following 2-years of assessment period in the OPTIC parent study). In Part 2 of the OPTIC-EXT study consenting participants will have 5 annual in-clinic assessments for an additional 5 years of long-term follow-up following the completion of OPTIC-EXT (Part 1). As such participants who complete the parent study as well as Part 1 and Part 2 of the OPTIC-EXT study will have had 10 years of total long-term follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Participants with wet AMD who received any dose of ADVM-022 in a prior clinical study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADVM-022 | Biological | Long term follow-up of subjects that received ADVM-022 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity and incidence of ocular and systemic adverse events (AEs). | Severity and incidence of ocular and systemic adverse events | 416 weeks (8 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in best corrected visual acuity (BCVA) from baseline, over time | Mean change in best corrected visual acuity (BCVA) from baseline, over time | 416 weeks (8 years) |
| Mean change in central subfield thickness (CST) and macular volume from baseline, over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| OPTIC-EXT Medical Monitor | Adverum Biotechnologies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adverum Clinical Site | Bakersfield | California | 93309 | United States | ||
| Adverum Clinical Site |
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Mean change in central subfield thickness (CST) and macular volume from baseline, over time |
| 416 weeks (8 years) |
| Mean number of supplemental aflibercept injections over time | Mean number of supplemental aflibercept injections over time | 416 weeks (8 years) |
| Percentage of participants requiring supplemental bolus aflibercept over time | Percentage of participants requiring supplemental bolus aflibercept over time | 416 weeks (8 years) |
| Time to first supplemental aflibercept requirement | Time to first supplemental aflibercept requirement | 416 weeks (8 years) |
| Percentage of participants without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time | Percentage of participants without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time | 416 weeks (8 years) |
| Percentage of participants without subretinal fluid (SRF) by SD-OCT over time | Percentage of participants without subretinal fluid (SRF) by SD-OCT over time | 416 weeks (8 years) |
| Time to first dry retina (defined as no IRF or SRF by SD-OCT) | Time to first dry retina (defined as no IRF or SRF by SD-OCT) | 416 weeks (8 years) |
| Duration of fluid free status (defined as no IRF or SRF by SD-OCT) | Duration of fluid free status (defined as no IRF or SRF by SD-OCT) | 416 weeks (8 years) |
| Percentage of participants developing geographic atrophy over time (as assessed by multiple imaging modalities) | Percentage of participants developing geographic atrophy over time (as assessed by multiple imaging modalities) | 416 weeks (8 years) |
| Growth of geographic atrophy over time, as assessed by multiple imaging modalities | Growth of geographic atrophy over time, as assessed by multiple imaging modalities | 416 weeks (8 years) |
| Percentage of participants with CST fluctuations > 50 μm over time | Percentage of participants with CST fluctuations > 50 μm over time | 416 weeks (8 years) |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Adverum Clinical Site | Lakewood | Colorado | 80228 | United States |
| Adverum Clinical Site | Deerfield Beach | Florida | 33064 | United States |
| Adverum Clinical Site | Reno | Nevada | 89502 | United States |
| Adverum Clinical Site | Philadelphia | Pennsylvania | 19107 | United States |
| Adverum Clinical Site | Nashville | Tennessee | 37203 | United States |
| Adverum Clinical Site | Bellaire | Texas | 77401 | United States |
| Adverum Clinical Site | The Woodlands | Texas | 77384 | United States |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D001766 | Blindness |
| D008268 | Macular Degeneration |
| D057135 | Wet Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D015785 | Eye Diseases, Hereditary |
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