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NCT05536973 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
A Phase 2 study of Neovascular Age-related Macular Degeneration, sponsored by Adverum Biotechnologies.
- Active
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT05536973 is a Phase 2 study of Neovascular Age-related Macular Degeneration that is active but no longer recruiting, run by Adverum Biotechnologies. The registered enrollment target is 69 participants, below the 406-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT05536973, a Phase 2 study of Neovascular Age-related Macular Degeneration, is active but no longer recruiting, sponsored by Adverum Biotechnologies.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study Summary
Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
Conditions Studied
Interventions
- GENETIC ADVM-022
Study Locations (20)
California
- Adverum Clinical Site 100 - Beverly Hills
- Adverum Clinical Site 172 - Encino
- Adverum Clinical Site 169 - Fullerton
- Adverum Clinical Site 170 - Pasadena
- Adverum Clinical Site 174 - Poway
- Adverum Clinical Site 164 - Riverside
- Adverum Clinical Site 166 - Sacramento
- Adverum Clinical Site 175 - Santa Barbara
Arizona
- Adverum Clinical Site 178 - Phoenix
- Adverum Clinical Site 126 - Phoenix
- Adverum Clinical Site 159 - Tucson
Florida
- Adverum Clinical Site 124 - Deerfield Beach
- Adverum Clinical Site 176 - Fort Lauderdale
- Adverum Clinical Site 168 - Jacksonville
Michigan
- Adverum Clinical Site 167 - Detroit
- Adverum Clinical Site 161 - Royal Oak
Colorado
- Adverum Clinical Site 116 - Lakewood
Connecticut
- Adverum Clinical Site 165 - Waterford
Hawaii
- Adverum Clinical Site 149 - ‘Aiea
Mississippi
- Adverum Clinical Site 163 - Southaven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2022-08-23 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05536973
The ClinicalTrials.gov registry entry for NCT05536973 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 406-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (83% lower). The listed sponsor is Adverum Biotechnologies, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which ADVM-022 is the first listed.
NCT05536973 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT05536973 about?
NCT05536973 is a clinical study titled "Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]". Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process...
What is the current status of trial NCT05536973?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2022-08-23. Estimated completion is 2028-08.
What conditions does trial NCT05536973 study?
This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.
What interventions are being tested in trial NCT05536973?
The interventions under investigation include: ADVM-022 (GENETIC).
Who is sponsoring clinical trial NCT05536973?
This trial is sponsored by Adverum Biotechnologies, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05536973 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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