Clinical trial NCT04645212: Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]
Official title: A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Wet Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration
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
Lead sponsor: Adverum Biotechnologies, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Subjects who received ADVM-022 at any dose in the OPTIC study
* Up to 30 subjects from all cohorts of OPTIC

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).

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.

Eligibility 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

Primary outcomes:
measure: Type, severity and incidence of ocular and systemic adverse events (AEs).
timeFrame: 156 weeks
Secondary outcomes:
measure: Change in best corrected visual acuity (BCVA) from baseline, over time
timeFrame: 156 weeks
measure: Mean change in central subfield thickness (CST) and macular volume from baseline, over time
timeFrame: 156 weeks
measure: Percentage of subjects requiring supplemental aflibercept over time
timeFrame: 156 weeks
measure: Mean number of supplemental aflibercept injections over time
timeFrame: 156 weeks
measure: Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time
timeFrame: 156 weeks
measure: Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time
timeFrame: 156 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Adverum Clinical Site
state: California
city: Beverly Hills
country: United States
facility: Adverum Clinical Site
state: California
city: Lakewood
country: United States
facility: Adverum Clinical Site
state: Colorado
city: Deerfield Beach
country: United States
facility: Adverum Clinical Site
state: Florida
city: Reno
country: United States
facility: Adverum Clinical Site
state: Nevada
city: Philadelphia
country: United States
facility: Adverum Clinical Site
state: Pennsylvania
city: Nashville
country: United States
facility: Adverum Clinical Site
state: Tennessee
city: Bellaire
country: United States
facility: Adverum Clinical Site
state: Texas
city: The Woodlands
country: United States
facility: Adverum Clinical Site
state: Texas
Study officials:
affiliation: Adverum Biotechnologies, Inc.
name: OPTIC Medical Monitor
role: STUDY_DIRECTOR
References: