Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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No Intervention - Subjects who received ADVM-022 in prior clinical study
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Genetic: ADVM-022
Long term follow-up of subjects who previously received ADVM-022
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of ocular and non-ocular adverse events (AEs) [168 Weeks]
- Severity of ocular and non-ocular AEs [168 Weeks]
Secondary Outcome Measures
- Time to worsening of DME disease activity [168 Weeks]
- Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT [168 Weeks]
- Change from Baseline in BCVA over time [168 Weeks]
- Incidence of 2-step and 3-step improvement in DRSS score over time [168 Weeks]
- Incidence of 2-step and 3-step worsening in DRSS score over time [168 Weeks]
- Frequency of supplemental aflibercept (2mg IVT) injections over time [168 Weeks]
- Occurrence of vision-threatening complications over time [168 Weeks]
- Incidence of CST < 300 μm over time [168 Weeks]
- Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation [168 Weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must have participated in the ADVM-022-04 [INFINITY] (parent) study and received ADVM-022
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Must provide signed informed consent
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Must be willing and able to comply with all study procedures
Exclusion Criteria:
- None
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- ADVM-022-10