Neovascular Age-related Macular Degeneration, Wet Age-related Macular Degeneration
Conditions
Keywords
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, AAV, Ixoberogene soroparvovec, Ixo-vec, Neovascular age-related macular degeneration, Adeno-associated viruses, Eye disease
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALADVM-022
Long term follow-up of subjects that received ADVM-022
Sponsors
Adverum Biotechnologies, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity and incidence of ocular and systemic adverse events (AEs). | 416 weeks (8 years) | Severity and incidence of ocular and systemic adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in best corrected visual acuity (BCVA) from baseline, over time | 416 weeks (8 years) | Mean change in best corrected visual acuity (BCVA) from baseline, over time |
| Mean change in central subfield thickness (CST) and macular volume from baseline, over time | 416 weeks (8 years) | Mean change in central subfield thickness (CST) and macular volume from baseline, over time |
| Mean number of supplemental aflibercept injections over time | 416 weeks (8 years) | Mean number of supplemental aflibercept injections over time |
| Percentage of participants requiring supplemental bolus aflibercept over time | 416 weeks (8 years) | Percentage of participants requiring supplemental bolus aflibercept over time |
| Time to first supplemental aflibercept requirement | 416 weeks (8 years) | Time to first supplemental aflibercept requirement |
| 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 intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time |
| Percentage of participants without subretinal fluid (SRF) by SD-OCT over time | 416 weeks (8 years) | Percentage of participants without subretinal fluid (SRF) by SD-OCT over time |
| Time to first dry retina (defined as no IRF or SRF by SD-OCT) | 416 weeks (8 years) | Time to first dry retina (defined as no IRF or SRF by SD-OCT) |
| Percentage of participants developing geographic atrophy over time (as assessed by multiple imaging modalities) | 416 weeks (8 years) | Percentage of participants developing 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) | Growth of geographic atrophy over time, as assessed by multiple imaging modalities |
| Duration of fluid free status (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) |
| Percentage of participants with CST fluctuations > 50 μm over time | 416 weeks (8 years) | Percentage of participants with CST fluctuations \> 50 μm over time |
Countries
United States
Contacts
STUDY_DIRECTOROPTIC-EXT Medical Monitor
Adverum Biotechnologies, Inc.
Outcome results
None listed