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Wet Age-related Macular DegenerationPhase 1OPTICNCT03748784

ADVM-022 Intravitreal Gene Therapy for Wet AMD

A Phase 1 study testing ADVM-022 in people with Wet Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Adverum Biotechnologies, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
ADVM-022
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
11 sitesUnited States
Study dates
14 Nov 2018to 22 Jun 2022
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age ≥ 50
  • Diagnosis of neovascular (wet) AMD
  • BCVA ETDRS Snellen equivalent between ≤20/32 and ≥20/320 for each cohort
  • Subjects must be under active anti-VEGF treatment for wAMD and received a minimum of 2 injections within 4 months prior to screening
  • Demonstrated a meaningful response to anti-VEGF therapy
  • Willing and able to provide consent

Who cannot join

  • History of retinal disease in the study eye other than wet AMD
  • Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye, or any condition preventing visual acuity improvement
  • History of retinal detachment (with or without repair) in the study eye
  • History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
  • Uncontrolled glaucoma in the study eye
  • Any prior treatment with photodynamic therapy or retinal laser for the treatment of wet AMD and any previous therapeutic radiation in the region of the study eye
Show all 9Show fewer
  • Any previous intraocular or periocular surgery on the study eye within 6 months
  • Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
  • Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Adverum Clinical Site

    Abilene, Texas, 79606

  • Adverum Clinical Site

    Bakersfield, California, 93309

  • Adverum Clinical Site

    Beverly Hills, California, 90211

  • Adverum Clinical Site

    Deerfield Beach, Florida, 33064

  • Adverum Clinical Site

    Golden, Colorado, 80401

  • Adverum Clinical Site

    Houston, Texas, 77030

  • Adverum Clinical Site

    Nashville, Tennessee, 37203

  • Adverum Clinical Site

    Philadelphia, Pennsylvania, 19107

  • Adverum Clinical Site

    Reno, Nevada, 89502

  • Adverum Clinical Site

    The Woodlands, Texas, 77384

  • Adverum Clinical Site

    West Columbia, South Carolina, 29169

Other trials in United States

About this study

Official title: An Open Label Phase 1 Study of ADVM-022 (AAV.7m8-aflibercept) in Neovascular (Wet) Age-Related Macular Degeneration

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.

Read the detailed description

This open-label, multicenter, dose-ranging study will evaluate 2 dose levels in up to 30 subjects (15 per dose) with active choroidal neovascularization (CNV) secondary to AMD. Subjects who are under active anti-VEGF treatment and have demonstrated a meaningful response to anti-VEGF therapy will be considered for participation in this study. The primary endpoint for this study is safety and tolerability of ADVM-022. All subjects will continue to be assessed for 104 weeks following treatment with ADVM-022.

Being tested
ADVM-022
Keywords
Choroidal Neovascularizatio, ADVM-022, CNV, ADVM-022-01, AAV.7m8, Anti-VEGF therapy, Blindness, Gene therapy, Aflibercept (Eylea), Age-Related Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, AAV Vector, Adverum, wAMD, AMD, wet AMD
Medical subject headings
Blindness, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases

What participants receive

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

  • ADVM-022Biological

    Also called AAV.7m8-aflibercept

    ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept

Study groups in NCT03748784
Study groupRoleWhat they receive
Dose 1Experimental6E11 vg of ADVM-022
Receives: Biological: ADVM-022
Dose 2Experimental2E11 vg of ADVM-022
Receives: Biological: ADVM-022

What is being measured

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

  1. Type, severity, and incidence of ocular and systemic adverse events (AEs)

    Type, severity, and incidence of ocular and systemic adverse events (AEs)

    Measured: 104 weeks

Secondary outcomes (6)

  1. Change in best corrected visual acuity (BCVA)

    Change in best corrected visual acuity (BCVA)

    Measured: 104 weeks

  2. Change in central subfield thickness (CST) and macular volume measured by SD-OCT

    Change in central subfield thickness (CST) and macular volume measured by SD-OCT

    Measured: 104 weeks

  3. Percentage of subjects requiring anti-VEGF injections over time

    Percentage of subjects requiring anti-VEGF injections over time

    Measured: 104 weeks

  4. Mean number of anti-VEGF injections over time

    Mean number of anti-VEGF injections over time

    Measured: 104 weeks

  5. Percentage of subjects without intraretinal fluid over time

    Percentage of subjects without intraretinal fluid over time

    Measured: 104 weeks

  6. Percentage of subjects without subretinal fluid over time

    Percentage of subjects without subretinal fluid over time

    Measured: 104 weeks

Timeline

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

  1. First posted21 Nov 2018
  2. Study start14 Nov 2018
  3. Primary completion22 Jun 2022
  4. Study completion22 Jun 2022

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Open-label, dose-ranging clinical study to evaluate the safety and tolerability of ADVM-022 in subjects with wet AMD.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03748784
Sponsor's protocol ID
ADVM-022-01
Acronym
OPTIC
Status last verified
Aug 2023
First submitted
19 Nov 2018
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Khanani AM, Boyer DS, Wykoff CC, Regillo CD, Busbee BG, Pieramici D, Danzig CJ, Joondeph BC, Major JC Jr, Turpcu A, Kiss S. Safety and efficacy of ixoberogene soroparvovec in neovascular age-related macular degeneration in the United States (OPTIC): a prospective, two-year, multicentre phase 1 study. EClinicalMedicine. 2023 Dec 22;67:102394. doi: 10.1016/j.eclinm.2023.102394. eCollection 2024 Jan.

    PubMed 38152412

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADVM-022 in people with Wet Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Adverum Biotechnologies, Inc. at 11 sites in United States.

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 9 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: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Type, severity, and incidence of ocular and systemic adverse events (AEs) (time frame: 104 weeks). 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 NCT03748784, which also lists 1 linked publication.

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 8 Aug 2023; AzTrials last refreshed its copy on 1 Nov 2026.

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