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.
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.
Study Type
OBSERVATIONAL
Enrollment
22
Long term follow-up of subjects who previously received ADVM-022
Adverum Clinical Site
Beverly Hills, California, United States
Adverum Clinical Site
Reno, Nevada, United States
Adverum Clinical Site
Philadelphia, Pennsylvania, United States
Adverum Clinical Site
Austin, Texas, United States
Incidence of ocular and non-ocular adverse events (AEs)
Time frame: 168 Weeks
Severity of ocular and non-ocular AEs
Time frame: 168 Weeks
Time to worsening of DME disease activity
Time frame: 168 Weeks
Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT
Time frame: 168 Weeks
Change from Baseline in BCVA over time
Time frame: 168 Weeks
Incidence of 2-step and 3-step improvement in DRSS score over time
Time frame: 168 Weeks
Incidence of 2-step and 3-step worsening in DRSS score over time
Time frame: 168 Weeks
Frequency of supplemental aflibercept (2mg IVT) injections over time
Time frame: 168 Weeks
Occurrence of vision-threatening complications over time
Time frame: 168 Weeks
Incidence of CST < 300 μm over time
Time frame: 168 Weeks
Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation
Time frame: 168 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Adverum Clinical Site
Bellaire, Texas, United States
Adverum Clinical Site
The Woodlands, Texas, United States
Adverum Clinical Site
Arecibo, Puerto Rico