Diabetic Macular Edema, Diabetic Retinopathy
Conditions
Keywords
ADVM-022, ADVM-022-04, ADVM-022-10, AAV.7m8, Anti-VEGF therapy, Blindness, INFINITY, Gene therapy, Aflibercept (Eylea), Retinal Diseases, Eye Diseases, AAV Vector, Adverum, DME, DR, INFINITY-EXT, INFINITY-Extension, Diabetic eye disease, Long-term Extension, Long-term Follow-up, AAV vector
Brief summary
This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for enrollment upon completion of the end of study visit in the parent study.
Detailed description
This is a multi-center study to evaluate the long-term safety and tolerability of a single intravitreal (IVT) injection of ADVM-022 in a preceding parent study, ADVM-022-04 \[INFINITY\]. Participants will be followed for a total of 5 years post- ADVM-022 administration (inclusive of the parent study). There is no investigational treatment administered in this study.
Interventions
GENETICADVM-022
Long term follow-up of subjects who previously received ADVM-022
Sponsors
Adverum Biotechnologies, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have participated in the ADVM-022-04 \[INFINITY\] (parent) study and received ADVM-022 * Must provide signed informed consent * Must be willing and able to comply with all study procedures
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ocular and non-ocular adverse events (AEs) | 168 Weeks |
| Severity of ocular and non-ocular AEs | 168 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT | 168 Weeks |
| Change from Baseline in BCVA over time | 168 Weeks |
| Incidence of 2-step and 3-step worsening in DRSS score over time | 168 Weeks |
| Incidence of 2-step and 3-step improvement in DRSS score over time | 168 Weeks |
| Occurrence of vision-threatening complications over time | 168 Weeks |
| Incidence of CST < 300 μm over time | 168 Weeks |
| Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation | 168 Weeks |
| Frequency of supplemental aflibercept (2mg IVT) injections over time | 168 Weeks |
| Time to worsening of DME disease activity | 168 Weeks |
Countries
Puerto Rico, United States
Outcome results
None listed