NCT04645212

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 participants with neovascular, or exudative (wet), age-related macular degeneration (nAMD).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
50mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Dec 2020Jun 2030

First Submitted

Initial submission to the registry

November 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2030

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

9.5 years

First QC Date

November 20, 2020

Last Update Submit

February 6, 2026

Conditions

Wet Age-related Macular DegenerationNeovascular Age-related Macular Degeneration

Keywords

Choroidal NeovascularizationADVM-022OPTIC StudyCNVADVM-022-01ADVM-022-07AAV.7m8Anti-VEGF therapyBlindnessGene therapyAflibercept (Eylea)Age-Related Macular DegenerationWet Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesAAV VectorAdverumwAMDAMDwet AMDnAMDOPTIC ExtensionOPTIC-EXTLong-term Follow UpLong-term ExtensionAAVIxoberogene soroparvovecIxo-vecNeovascular age-related macular degenerationAdeno-associated virusesEye disease

Outcome Measures

Primary Outcomes (1)

  • Severity and incidence of ocular and systemic adverse events (AEs).

    Severity and incidence of ocular and systemic adverse events

    416 weeks (8 years)

Secondary Outcomes (12)

  • Mean change in best corrected visual acuity (BCVA) from baseline, over time

    416 weeks (8 years)

  • Mean change in central subfield thickness (CST) and macular volume from baseline, over time

    416 weeks (8 years)

  • Mean number of supplemental aflibercept injections over time

    416 weeks (8 years)

  • Percentage of participants requiring supplemental bolus aflibercept over time

    416 weeks (8 years)

  • Time to first supplemental aflibercept requirement

    416 weeks (8 years)

  • +7 more secondary outcomes

Study Arms (1)

1

Participants with wet AMD who received any dose of ADVM-022 in a prior clinical study.

Biological: ADVM-022

Interventions

ADVM-022BIOLOGICAL

Long term follow-up of subjects that received ADVM-022

Also known as: AAV.7m8-aflibercept
1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Participants who received ADVM-022 at any dose in the OPTIC study * Up to 30 participants from all cohorts of OPTIC

You may qualify if:

  • Participants who received a single dose of ADVM-022 at any dose in the OPTIC study
  • Willing and able to provide informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Adverum Clinical Site

Bakersfield, California, 93309, United States

Location

Adverum Clinical Site

Beverly Hills, California, 90211, United States

Location

Adverum Clinical Site

Lakewood, Colorado, 80228, United States

Location

Adverum Clinical Site

Deerfield Beach, Florida, 33064, United States

Location

Adverum Clinical Site

Reno, Nevada, 89502, United States

Location

Adverum Clinical Site

Philadelphia, Pennsylvania, 19107, United States

Location

Adverum Clinical Site

Nashville, Tennessee, 37203, United States

Location

Adverum Clinical Site

Bellaire, Texas, 77401, United States

Location

Adverum Clinical Site

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Conditions

Choroidal NeovascularizationBlindnessMacular DegenerationWet Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsEye Diseases, Hereditary

Study Officials

  • OPTIC-EXT Medical Monitor

    Adverum Biotechnologies, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 27, 2020

Study Start

December 14, 2020

Primary Completion (Estimated)

June 26, 2030

Study Completion (Estimated)

June 26, 2030

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(9)