Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)

Sponsor
Adverum Biotechnologies, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05607810
Collaborator
(none)
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42.7
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: ADVM-022

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
22 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Long-Term Follow-Up Study of ADVM-022 in Diabetic Macular Edema- INFINITY Extension
Actual Study Start Date :
Aug 10, 2022
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
No Intervention - Subjects who received ADVM-022 in prior clinical study

Genetic: ADVM-022
Long term follow-up of subjects who previously received ADVM-022
Other Names:
  • AAV.7m8-aflibercept
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of ocular and non-ocular adverse events (AEs) [168 Weeks]

    2. Severity of ocular and non-ocular AEs [168 Weeks]

    Secondary Outcome Measures

    1. Time to worsening of DME disease activity [168 Weeks]

    2. Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT [168 Weeks]

    3. Change from Baseline in BCVA over time [168 Weeks]

    4. Incidence of 2-step and 3-step improvement in DRSS score over time [168 Weeks]

    5. Incidence of 2-step and 3-step worsening in DRSS score over time [168 Weeks]

    6. Frequency of supplemental aflibercept (2mg IVT) injections over time [168 Weeks]

    7. Occurrence of vision-threatening complications over time [168 Weeks]

    8. Incidence of CST < 300 μm over time [168 Weeks]

    9. Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation [168 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Adverum Clinical Site Beverly Hills California United States 90211
    2 Adverum Clinical Site Reno Nevada United States 89502
    3 Adverum Clinical Site Philadelphia Pennsylvania United States 19107
    4 Adverum Clinical Site Austin Texas United States 78705
    5 Adverum Clinical Site Bellaire Texas United States 77030
    6 Adverum Clinical Site The Woodlands Texas United States 77384
    7 Adverum Clinical Site Arecibo Puerto Rico 00612

    Sponsors and Collaborators

    • Adverum Biotechnologies, Inc.

    Investigators

    • Study Director: Michael Friedman, Ph.D., Adverum Biotechnologies

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Adverum Biotechnologies, Inc.
    ClinicalTrials.gov Identifier:
    NCT05607810
    Other Study ID Numbers:
    • ADVM-022-10
    First Posted:
    Nov 7, 2022
    Last Update Posted:
    Nov 7, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Adverum Biotechnologies, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 7, 2022