Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
NCT ID: NCT05536973
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
69 participants
INTERVENTIONAL
2022-08-23
2028-08-31
Brief Summary
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Detailed Description
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Anti-VEGF treatment-experienced study participants meeting the eligibility criteria that will be randomized between the 2E11 vg/eye and 6E10 vg/eye ADVM-022 doses each with 4 prophylaxis arms for a total of 8 treatment arms, and only one eye per study participant will be selected as the study eye.
Safety, tolerability, and efficacy will be evaluated for a period of approximately 5 years from baseline.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dose 1
A single intravitreal injection of ADVM-022 2E11 vg/eye
ADVM-022
A single IVT injection of 2E11 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens
Dose 2
A single intravitreal injection of ADVM-022 6E10 vg/eye
ADVM-022
A single IVT injection of 6E10 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens
Interventions
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ADVM-022
A single IVT injection of 2E11 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens
ADVM-022
A single IVT injection of 6E10 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide written, signed informed consent for this study
* Demonstrated a meaningful response to anti-VEGF therapy
* Participants must be under active anti-VEGF treatment for wet AMD and received a minimum of 2 injections within 4 months prior to screening for the treatment of choroidal neovascularization secondary to nAMD in the study eye
* Vision of the study eye at Baseline: BCVA in the range of 25 - 83 ETDRS letters, inclusive (approximate Snellen equivalent visual acuity range of 20/25 - 20/320)
* Vision of the non-study eye at Baseline: BCVA ≥ 35 ETDRS letters (approximate Snellen equivalent of 20/200 or better)
Exclusion Criteria
* Ocular or periocular infection or intraocular inflammation in either eye within 1 month prior to or at the Randomization Visit (Day -7)
* Uncontrolled diabetes or HbA1c ≥ 7.0 %
* History or evidence of significant uncontrolled concomitant disease within 6 months of the Screening visit
* Any history of ongoing bleeding disorders or INR \>3.0
* History or evidence of macular or retinal disease other than nAMD
* History or evidence of retinal detachment or retinal pigment epithelium rip/tear
* Uncontrolled ocular hypertension or glaucoma
* Prior treatment with photodynamic therapy or retinal laser for the treatment of nAMD
* Any history of vitrectomy or any other vitreoretinal surgery
* Prior treatment with gene therapy at any time or any non-gene therapy investigational treatment or medical device in the study eye within 3 months of the Screening Visit or 5 half-lives of the investigational medicinal product
50 Years
ALL
No
Sponsors
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Adverum Biotechnologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Turpcu, PhD
Role: STUDY_DIRECTOR
Adverum Biotechnologies, Inc.
Locations
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Adverum Clinical Site 178
Phoenix, Arizona, United States
Adverum Clinical Site 126
Phoenix, Arizona, United States
Adverum Clinical Site 159
Tucson, Arizona, United States
Adverum Clinical Site 100
Beverly Hills, California, United States
Adverum Clinical Site 172
Encino, California, United States
Adverum Clinical Site 169
Fullerton, California, United States
Adverum Clinical Site 170
Pasadena, California, United States
Adverum Clinical Site 174
Poway, California, United States
Adverum Clinical Site 164
Riverside, California, United States
Adverum Clinical Site 166
Sacramento, California, United States
Adverum Clinical Site 175
Santa Barbara, California, United States
Adverum Clinical Site 116
Lakewood, Colorado, United States
Adverum Clinical Site 165
Waterford, Connecticut, United States
Adverum Clinical Site 124
Deerfield Beach, Florida, United States
Adverum Clinical Site 176
Fort Lauderdale, Florida, United States
Adverum Clinical Site 168
Jacksonville, Florida, United States
Adverum Clinical Site 149
‘Aiea, Hawaii, United States
Adverum Clinical Site 167
Detroit, Michigan, United States
Adverum Clinical Site 161
Royal Oak, Michigan, United States
Adverum Clinical Site 163
Southaven, Mississippi, United States
Adverum Clinical Site 177
Omaha, Nebraska, United States
Adverum Clinical Site 119
Reno, Nevada, United States
Adverum Clinical Site 146
Cherry Hill, New Jersey, United States
Adverum Clinical Site 171
Teaneck, New Jersey, United States
Adverum Clinical Site 122
West Columbia, South Carolina, United States
Adverum Clinical Site 144
Rapid City, South Dakota, United States
Adverum Clinical Site 101
Nashville, Tennessee, United States
Adverum Clinical Site 123
Abilene, Texas, United States
Adverum Clinical Site 154
Austin, Texas, United States
Adverum Clinical Site 108
Bellaire, Texas, United States
Adverum Clinical Site 162
McAllen, Texas, United States
Adverum Clinical Site 151
San Antonio, Texas, United States
Adverum Clinical Site 107
The Woodlands, Texas, United States
Adverum Clinical Site 152
Morgantown, West Virginia, United States
Adverum Clinical Site 502
Nantes, Loire-Atlantique, France
Adverum Clinical Site 501
Lyon, Rhône, France
Adverum Clinical Site 500
Créteil, Val-de-Marne, France
Adverum Clinical Site 600
London, , United Kingdom
Adverum Clinical Site 601
Oxford, , United Kingdom
Countries
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Other Identifiers
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ADVM-022-11
Identifier Type: -
Identifier Source: org_study_id
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