Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]
Study Details
Study Description
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 subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Subjects with wet AMD who received any dose of ADVM-022 in a prior clinical study. |
Biological: ADVM-022
Long term follow-up of subjects that received ADVM-022
Other Names:
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Outcome Measures
Primary Outcome Measures
- Type, severity and incidence of ocular and systemic adverse events (AEs). [156 weeks]
Type, severity and incidence of ocular and systemic adverse events
Secondary Outcome Measures
- Change in best corrected visual acuity (BCVA) from baseline, over time [156 weeks]
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 [156 weeks]
Mean change in central subfield thickness (CST) and macular volume from baseline, over time
- Percentage of subjects requiring supplemental aflibercept over time [156 weeks]
Percentage of subjects requiring supplemental aflibercept over time
- Mean number of supplemental aflibercept injections over time [156 weeks]
Mean number of supplemental aflibercept injections 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 intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time
- Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time [156 weeks]
Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Adverum Clinical Site | Bakersfield | California | United States | 93309 |
| 2 | Adverum Clinical Site | Beverly Hills | California | United States | 90211 |
| 3 | Adverum Clinical Site | Lakewood | Colorado | United States | 80228 |
| 4 | Adverum Clinical Site | Deerfield Beach | Florida | United States | 33064 |
| 5 | Adverum Clinical Site | Reno | Nevada | United States | 89502 |
| 6 | Adverum Clinical Site | Philadelphia | Pennsylvania | United States | 19107 |
| 7 | Adverum Clinical Site | Nashville | Tennessee | United States | 37203 |
| 8 | Adverum Clinical Site | Bellaire | Texas | United States | 77401 |
| 9 | Adverum Clinical Site | The Woodlands | Texas | United States | 77384 |
Sponsors and Collaborators
- Adverum Biotechnologies, Inc.
Investigators
- Study Director: OPTIC Medical Monitor, Adverum Biotechnologies, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADVM-022-07