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Neovascular Age-related Macular DegenerationPhase 2NCT05536973

Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]

A Phase 2 study testing ADVM-022 in people with Neovascular Age-related Macular Degeneration, run by Adverum Biotechnologies, Inc. at 39 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
ADVM-022
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
39 sitesin 3 countries
Study dates
23 Aug 2022to Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participants, ≥ 50 years of age
  • 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)

Who cannot join

  • Any condition that could affect the interpretation of results or render the participant at high risk of treatment complications in the opinion of the Investigator
  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

United States34 sites

  • Adverum Clinical Site 149

    ‘Aiea, Hawaii, 96701

  • Adverum Clinical Site 123

    Abilene, Texas, 79606

  • Adverum Clinical Site 154

    Austin, Texas, 78705

  • Adverum Clinical Site 108

    Bellaire, Texas, 77401

  • Adverum Clinical Site 100

    Beverly Hills, California, 90211

  • Adverum Clinical Site 146

    Cherry Hill, New Jersey, 08034

  • Adverum Clinical Site 124

    Deerfield Beach, Florida, 33064

  • Adverum Clinical Site 167

    Detroit, Michigan, 48201

  • Adverum Clinical Site 172

    Encino, California, 91436

  • Adverum Clinical Site 176

    Fort Lauderdale, Florida, 33308

  • Adverum Clinical Site 169

    Fullerton, California, 92835

  • Adverum Clinical Site 168

    Jacksonville, Florida, 32216

  • Adverum Clinical Site 116

    Lakewood, Colorado, 80228

  • Adverum Clinical Site 162

    McAllen, Texas, 78503

  • Adverum Clinical Site 152

    Morgantown, West Virginia, 26506

  • Adverum Clinical Site 101

    Nashville, Tennessee, 37203

  • Adverum Clinical Site 177

    Omaha, Nebraska, 68105

  • Adverum Clinical Site 170

    Pasadena, California, 91105

  • Adverum Clinical Site 178

    Phoenix, Arizona, 85020

  • Adverum Clinical Site 126

    Phoenix, Arizona, 85053

  • Adverum Clinical Site 174

    Poway, California, 92064

  • Adverum Clinical Site 144

    Rapid City, South Dakota, 57701

  • Adverum Clinical Site 119

    Reno, Nevada, 89502

  • Adverum Clinical Site 164

    Riverside, California, 92505

  • Adverum Clinical Site 161

    Royal Oak, Michigan, 48073

  • Adverum Clinical Site 166

    Sacramento, California, 95817

  • Adverum Clinical Site 151

    San Antonio, Texas, 78240

  • Adverum Clinical Site 175

    Santa Barbara, California, 93103

  • Adverum Clinical Site 163

    Southaven, Mississippi, 38671

  • Adverum Clinical Site 171

    Teaneck, New Jersey, 07666

  • Adverum Clinical Site 107

    The Woodlands, Texas, 77384

  • Adverum Clinical Site 159

    Tucson, Arizona, 85704

  • Adverum Clinical Site 165

    Waterford, Connecticut, 06385

  • Adverum Clinical Site 122

    West Columbia, South Carolina, 29169

Other trials in United States

France3 sites

  • Adverum Clinical Site 500

    Créteil, Val-de-Marne, 94000

  • Adverum Clinical Site 501

    Lyon, Rhône, 69004

  • Adverum Clinical Site 502

    Nantes, Loire-Atlantique, 44093

Other trials in France

United Kingdom2 sites

  • Adverum Clinical Site 600

    London, EC1V 2PD

  • Adverum Clinical Site 601

    Oxford, OX3 9DU

Other trials in United Kingdom

About this study

Official title: A Multi-Center, Randomized, Double-Masked Phase 2 Study to Assess Safety and Efficacy of ADVM-022 (AAV.7m8-aflibercept) in Anti-VEGF Treatment-Experienced Patients With Neovascular (Wet) Age-related Macular Degeneration (nAMD) [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 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.

Read the detailed description

This Phase 2, multi-center, randomized, double-masked, parallel group study is designed to evaluate the safety, tolerability, and efficacy of a single IVT injection of ADVM-022 at one of two doses (2 × 10^11 vg/eye [2E11] or 6 × 10^10 vg/eye [6E10]) accompanied by one of four prophylactic corticosteroid treatment regimens.

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.

Being tested
ADVM-022
Keywords
Aflibercept, Best Corrected Visual Acuity, Adverum, ADVM, ADVM-022, ADVM-022-11, Age-related macular degeneration, Wet macular degeneration, Wet AMD, Choroidal neovascularization, CNV, AAV.7m8, Anti-VEGF therapy, Gene therapy, Blindness, AAV, AAV vector, nAMD, wAMD, Eye disease
Medical subject headings
Macular Degeneration, Wet Macular Degeneration, Choroidal Neovascularization, Blindness, Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADVM-022Genetic

    A single IVT injection of 2E11 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens

  • ADVM-022Genetic

    A single IVT injection of 6E10 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens

Study groups in NCT05536973
Study groupRoleWhat they receive
Dose 1ExperimentalA single intravitreal injection of ADVM-022 2E11 vg/eye
Receives: Genetic: ADVM-022
Dose 2ExperimentalA single intravitreal injection of ADVM-022 6E10 vg/eye
Receives: Genetic: ADVM-022

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ocular and non-ocular adverse events

    Incidence of ocular and non-ocular adverse events

    Measured: Up to Week 52

  2. Severity of ocular and non-ocular adverse events

    Severity of ocular and non-ocular adverse events

    Measured: Up to Week 52

  3. Mean change in best corrected visual acuity (BCVA) from Baseline

    BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)

    Measured: Baseline up to Week 52

Secondary outcomes (10)

  1. Percentage of participants from Baseline who lose/gain at least 5, 10 or 15 letters in BCVA

    BCVA measured by ETDRS

    Measured: Baseline up to 5 years

  2. Mean change in BCVA from Baseline

    BCVA measured by ETDRS

    Measured: Baseline up to 5 years

  3. Percentage of participants who are supplemental aflibercept injection-free

    Supplemental anti-VEGF treatments required post therapy

    Measured: Baseline up to 5 years

  4. Percent reduction in annualized anti-VEGF injections

    Supplemental annualized anti-VEGF treatments required post therapy to the year prior

    Measured: Baseline up to 5 years

  5. Mean change in Central Subfield Thickness (CST) from Baseline

    To evaluate the effect of ADVM-022 on CST

    Measured: Baseline up to 5 years

  6. Percentage of participants without CST fluctuations

    To evaluate the effect of ADVM-022 on CST

    Measured: Baseline up to 5 years

  7. Mean number of CST fluctuations from Baseline

    To evaluate the effect of ADVM-022 on CST

    Measured: Baseline up to 5 years

  8. Percentage of participants without post-prophylactic inflammation

    To assess the long-term safety and tolerability of a single IVT injection of ADVM-022

    Measured: Baseline up to 5 years

  9. Incidence of ocular and non-ocular adverse events

    To assess the long-term safety and tolerability of a single IVT injection of ADVM-022

    Measured: Up to 60 months

  10. Severity of ocular and non-ocular adverse events

    To assess the long-term safety and tolerability of a single IVT injection of ADVM-022

    Measured: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start23 Aug 2022
  3. Primary completion26 Aug 2024
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05536973
Sponsor's protocol ID
ADVM-022-11
Status last verified
Aug 2026
First submitted
8 Sep 2022
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADVM-022 in people with Neovascular Age-related Macular Degeneration, run by Adverum Biotechnologies, Inc. at 39 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of ocular and non-ocular adverse events (time frame: Up to Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05536973.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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