Clinical trial NCT05607810: Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Official title: A Long-Term Follow-Up Study of ADVM-022 in Diabetic Macular Edema- INFINITY Extension
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Macular Edema
Diabetic Retinopathy
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
Lead sponsor: Adverum Biotechnologies, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received ADVM-022 at any dose in the INFINITY study

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of ocular and non-ocular adverse events (AEs)
timeFrame: 168 Weeks
measure: Severity of ocular and non-ocular AEs
timeFrame: 168 Weeks
Secondary outcomes:
measure: Time to worsening of DME disease activity
timeFrame: 168 Weeks
measure: Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT
timeFrame: 168 Weeks
measure: Change from Baseline in BCVA over time
timeFrame: 168 Weeks
measure: Incidence of 2-step and 3-step improvement in DRSS score over time
timeFrame: 168 Weeks
measure: Incidence of 2-step and 3-step worsening in DRSS score over time
timeFrame: 168 Weeks
measure: Frequency of supplemental aflibercept (2mg IVT) injections over time
timeFrame: 168 Weeks
measure: Occurrence of vision-threatening complications over time
timeFrame: 168 Weeks
measure: Incidence of CST < 300 μm over time
timeFrame: 168 Weeks
measure: Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation
timeFrame: 168 Weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Adverum Clinical Site
state: California
city: Reno
country: United States
facility: Adverum Clinical Site
state: Nevada
city: Philadelphia
country: United States
facility: Adverum Clinical Site
state: Pennsylvania
city: Austin
country: United States
facility: Adverum Clinical Site
state: Texas
city: Bellaire
country: United States
facility: Adverum Clinical Site
state: Texas
city: The Woodlands
country: United States
facility: Adverum Clinical Site
state: Texas
city: Arecibo
country: Puerto Rico
facility: Adverum Clinical Site
Study officials:
affiliation: Adverum Biotechnologies
name: Adam Turpcu, Ph.D.
role: STUDY_DIRECTOR
References: