Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT) | NCT05607810

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

NCT05607810

Sponsor

Adverum Biotechnologies, Inc.

Status

Active, not recruiting

Last Update Posted

Apr 22, 2025Actual

Enrollment

22Estimated

Phase

Not provided

Conditions

Diabetic Macular Edema
Diabetic Retinopathy

Interventions

ADVM-022

Countries

United States
Puerto Rico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2022Actual

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Oct 21, 2022

First Submission Date that Met QC Criteria

Nov 4, 2022

First Posted Date

Nov 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2025

Last Update Posted Date

Apr 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Intervention - Subjects who received ADVM-022 in prior clinical study			Genetic: ADVM-022

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ADVM-022	Genetic	Long term follow-up of subjects who previously received ADVM-022	No Intervention - Subjects who received ADVM-022 in prior clinical study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of ocular and non-ocular adverse events (AEs)		168 Weeks
Severity of ocular and non-ocular AEs		168 Weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who received ADVM-022 at any dose in the INFINITY study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam Turpcu, Ph.D.	Adverum Biotechnologies, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Adverum Clinical Site		Beverly Hills	California	90211	United States
Adverum Clinical Site

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy
D001766	Blindness
D012164	Retinal Diseases
D005128	Eye Diseases

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided