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

Active, not recruiting

• Conditions: Wet Age-related Macular Degeneration; Neovascular Age-related Macular Degeneration
• Interventions: Biological: ADVM-022

• Registration Number: NCT04645212
• Lead Sponsor: Adverum Biotechnologies, Inc.

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-27
• Study Start: 2020-12-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	ADVM-022	Subjects with wet AMD who received any dose of ADVM-022 in a prior clinical study.

Primary Outcome Measures

Name	Time	Method
Type, severity and incidence of ocular and systemic adverse events (AEs).	156 weeks	Type, severity and incidence of ocular and systemic adverse events

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time	156 weeks	Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time
Mean number of supplemental aflibercept injections over time	156 weeks	Mean number of supplemental aflibercept injections over time
Percentage of subjects requiring supplemental aflibercept over time	156 weeks	Percentage of subjects requiring supplemental aflibercept over time
Change in best corrected visual acuity (BCVA) from baseline, over time	156 weeks	Change in best corrected visual acuity (BCVA) from baseline, over time
Mean change in central subfield thickness (CST) and macular volume from baseline, over time	156 weeks	Mean change in central subfield thickness (CST) and macular volume from baseline, over time
Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time	156 weeks	Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time

Trial Locations

Locations (1)

Adverum Clinical Site; 🇺🇸 The Woodlands, Texas, United States