Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04645212
• Other study ID #: ADVM-022-07
• Status: Active, not recruiting
• Start date: December 14, 2020
• Est. completion date: June 2025

Study information

• Verified date: February 2023
• Source: Adverum Biotechnologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Biological:
• ADVM-022
Long term follow-up of subjects that received ADVM-022

Locations

Country	Name	City	State
United States	Adverum Clinical Site	Bakersfield	California
United States	Adverum Clinical Site	Bellaire	Texas
United States	Adverum Clinical Site	Beverly Hills	California
United States	Adverum Clinical Site	Deerfield Beach	Florida
United States	Adverum Clinical Site	Lakewood	Colorado
United States	Adverum Clinical Site	Nashville	Tennessee
United States	Adverum Clinical Site	Philadelphia	Pennsylvania
United States	Adverum Clinical Site	Reno	Nevada
United States	Adverum Clinical Site	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Adverum Biotechnologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, severity and incidence of ocular and systemic adverse events (AEs).	Type, severity and incidence of ocular and systemic adverse events	156 weeks
Secondary	Change in best corrected visual acuity (BCVA) from baseline, over time	Change in best corrected visual acuity (BCVA) from baseline, over time	156 weeks
Secondary	Mean change in central subfield thickness (CST) and macular volume from baseline, over time	Mean change in central subfield thickness (CST) and macular volume from baseline, over time	156 weeks
Secondary	Percentage of subjects requiring supplemental aflibercept over time	Percentage of subjects requiring supplemental aflibercept over time	156 weeks
Secondary	Mean number of supplemental aflibercept injections over time	Mean number of supplemental aflibercept injections over time	156 weeks
Secondary	Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time	Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time	156 weeks
Secondary	Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time	Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time	156 weeks