Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration

4 sierpnia 2026 zaktualizowane przez: Adverum Biotechnologies, Inc.

Evaluation of the Safety and Tolerability of Ixoberogene Soroparvovec (Ixo-vec) Intravitreal Gene Therapy in the Second (Contralateral) Eye of Participants With Bilateral Neovascular Age-related Macular Degeneration.

The purpose of this study is to evaluate safety, effectiveness and durability of a gene therapy called Ixo-vec (Ixoberogene soroparvovec) when administered to the contralateral (second) eye of adult participants (≥ 50 years of age) who have been diagnosed with bilateral neovascular (wet) age related macular degeneration (nAMD). The study will enroll adults with nAMD in both eyes, including participants who previously received Ixo-vec treatment in one (initial) eye and/or participants who will receive Ixo-vec treatment for the first time. This study focuses on how the treatment works when both eyes are treated at different times and how effective and long-lasting Ixo-vec treatment is in the second (contralateral) eye.

Participants will receive a single administration of Ixo-vec in the contralateral eye and will be followed for approximately 5 years to evaluate safety, efficacy and durability of contralateral treatment. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy.

The study is intended to provide additional information on the safety, tolerability, and use of Ixo-vec in bilateral treatment.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a Phase 2, single-arm, open-label, multi-center study in participants who are ≥ 50 years old with a diagnosis of bilateral choroidal neovascularization (CNV) secondary to neovascular (wet) age related macular degeneration (nAMD). This study is designed to evaluate the safety, tolerability, and efficacy of Ixo-vec dosing in the contralateral (second) eye.

The study includes participants who have previously received Ixo-vec in one eye in a prior clinical study, as well as Ixo-vec-naïve participants eligible for sequential bilateral administration. The study will evaluate the use of Ixo-vec when both eyes are treated at different time points.

Neovascular AMD is a progressive retinal disease characterized by the growth of abnormal blood vessels originating from the choroid, which can lead to vision loss. Current standard of care includes repeated intravitreal (IVT) administration of anti-vascular endothelial growth factor (anti-VEGF) therapies.

Ixo-vec (also known as Ixoberogene soroparvovec, ADVM-022 or AAV.7m8-aflibercept) is an adeno-associated virus (AAV)-based gene therapy designed to enable sustained intraocular expression of an anti-VEGF protein following a single IVT administration.

The primary objective of this study is to assess the safety and tolerability of Ixo-vec administered to the contralateral eye. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy over time.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

15

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85053
        • Rekrutacyjny
        • Adverum site 126
    • California
      • Bakersfield, California, Stany Zjednoczone, 93309
        • Rekrutacyjny
        • Adverum site 109
      • Fullerton, California, Stany Zjednoczone, 92835
        • Rekrutacyjny
        • Adverum site 169
    • Florida
      • Deerfield Beach, Florida, Stany Zjednoczone, 33064
        • Rekrutacyjny
        • Adverum site 124
      • Fort Lauderdale, Florida, Stany Zjednoczone, 33308
        • Rekrutacyjny
        • Adverum site 176
      • Jacksonville, Florida, Stany Zjednoczone, 32216
        • Rekrutacyjny
        • Adverum site 168
    • Hawaii
      • ‘Aiea, Hawaii, Stany Zjednoczone, 96701
        • Rekrutacyjny
        • Adverum site 149
    • Illinois
      • Lemont, Illinois, Stany Zjednoczone, 60439
        • Rekrutacyjny
        • Adverum site 179
    • New Jersey
      • Teaneck, New Jersey, Stany Zjednoczone, 07666
        • Rekrutacyjny
        • Adverum site 171
    • South Carolina
      • West Columbia, South Carolina, Stany Zjednoczone, 29169
        • Rekrutacyjny
        • Adverum site 122
    • Texas
      • The Woodlands, Texas, Stany Zjednoczone, 77384
        • Rekrutacyjny
        • Adverum site 107
      • The Woodlands, Texas, Stany Zjednoczone, 77384
        • Rekrutacyjny
        • Adverum site 231

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

INCLUSION CRITERIA:

  1. Male or female, aged ≥ 50 years at Screening Visit 1.
  2. Must agree to use an acceptable form of contraception.
  3. Have diagnosis of bilateral CNV secondary to nAMD.

  4. Meet ETDRS BCVA letter score criteria:

    • For Ixo-vec-experienced participants: Contralateral eye has an ETDRS BCVA letter score within a protocol-defined range appropriate for nAMD clinical trials.
    • For Ixo-vec-naïve participants: Both the initial eye and contralateral eye have ETDRS BCVA letter score within a protocol-defined range appropriate for nAMD clinical trials
  5. Have prior treatment history consistent with protocol-defined requirements, including prior anti-VEGF therapy and, where applicable, prior Ixo-vec exposure.
  6. Demonstrate a meaningful anatomic response to anti-VEGF in the contralateral eye (all participants) and in the initial eye (Ixo-vec-naïve participants only). Meaningful anatomic response to prior anti-VEGF therapy as defined in the protocol.
  7. Able to comply with study procedures according to the Investigator's judgment.

Other protocol-defined INCLUSION CRITERIA apply.

EXCLUSION CRITERIA:

A/ General Exclusion Criteria

  1. Have history of a medical condition (systemic disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant's ability to comply with the planned study assessments, or that might affect the interpretation of the results of the study or render the participant at high risk for treatment complications in the opinion of the Investigator. History of severe coronavirus disease of 2019 (COVID-19) infection may meet this exclusion criterion if, in the opinion of the Investigator, it is likely to lead to any of the complications listed above.
  2. Received prior gene therapy (other than Ixo-vec, where applicable)
  3. Currently receiving steroids at Screening Visit 1 in the previously treated eye (Ixo-vec-experienced participants) or in either eye (Ixo-vec-naïve participants).
  4. Received any non-gene IMP or medical device in the contralateral eye (and/or initial eye for Ixo-vec-naïve participants) within 3 months of Screening Visit 1
  5. Have history of allergy, hypersensitivity, or contraindications to the use of any product or its excipients administered as part of this study.
  6. Have evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0%
  7. Have history or evidence of cardiovascular diseases and ongoing bleeding disorders as defined by the protocol.
  8. Use of systemic immunosuppressive therapy within a protocol-defined period.
  9. Received systemic anti-VEGF therapy within a protocol-defined period.

  10. Have history of malignancy within the 5 years prior to Screening Visit 1, except for adequately treated malignancies as defined by the protocol.

    B/Ocular Exclusion Criteria

  11. Have any active ocular or periocular infection in the contralateral eye in the contralateral eye (all participants) or in the initial eye (Ixo-vec-naïve participants only).
  12. Have any history or evidence of a concurrent intraocular condition in the contralateral eye (all participants) or in the initial eye (Ixo-vec-naïve participants only), including retinal diseases other than nAMD, that, in the judgment of the Investigator, could reduce the potential for visual improvement, confound assessment of the macula or require medical or surgical intervention during the study.
  13. Have prior ocular surgery or treatment that may confound assessment or increase risk.
  14. Have any history or evidence of retinal detachment (with or without repair) or retinal pigment epithelium rip/tear in the contralateral eye (all participants) or in the initial eye (Ixo-vec-naïve participants only), as determined by the Investigator.
  15. Have uncontrolled ocular hypertension or glaucoma as defined by the protocol.
  16. Have any history of inflammatory anterior chamber cell or vitreous cell ≥ 2+ in the initial eye, that, in the opinion of the Investigator and Sponsor, predisposes the contralateral eye to a heightened risk of intraocular inflammation. Enrollment of a participant with prior anterior chamber cell or vitreous cell ≥2+ in the initial eye requires discussion with the medical monitor.

Other protocol-defined EXCLUSION CRITERIA apply.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ixo-vec dosing in Contralateral Eye
Population of Ixo-vec-Experienced or Ixo-vec Naïve Participants.
Genetyczny: Ixo-vec
Ixo-vec (6 × 10^10 vg/eye) will be administered intravitreally

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of ocular adverse events (AEs)
Ramy czasowe: Baseline through Week 28
The number of participants who experience an ocular adverse event will be summarized.
Baseline through Week 28
Incidence of ocular serious adverse events (SAEs).
Ramy czasowe: Baseline through Week 28
The number of participants who experience ocular serious adverse event will be summarized.
Baseline through Week 28
Incidence of non-ocular serious adverse events (SAEs).
Ramy czasowe: Baseline through Week 28
The number of participants who experience non-ocular serious adverse event will be summarized.
Baseline through Week 28

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28.
Ramy czasowe: Baseline through Week 28
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
Baseline through Week 28
Mean change from baseline in central subfield thickness (CST) over time through Week 28.
Ramy czasowe: Baseline through Week 28
CST as measured by spectral domain optical coherence tomography (SD-OCT).
Baseline through Week 28
Mean number of supplemental aflibercept IVT injections received from Week 4 through Week 28
Ramy czasowe: Week 4 through Week 28
Efficacy will be measured by the number of supplemental aflibercept injections post Ixo-vec administration.
Week 4 through Week 28
Percentage of participants who are supplemental aflibercept injection-free through Week 28.
Ramy czasowe: Baseline through Week 28
Efficacy will be measured as the percentage of participants who will not received supplemental aflibercept injections post Ixo-vec administration.
Baseline through Week 28

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Adverum Biotechnologies, Inc.

Śledczy

  • Dyrektor Studium: Adam Turpcu, PhD, Adverum Biotechnologies, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2031

Ukończenie studiów (Szacowany)

1 czerwca 2031

Daty rejestracji na studia

Pierwszy przesłany

2 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ADVM-022-14

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Adverum is committed to transparency. Appropriately de-identified participant-level data and supporting documents may be shared under appropriate conditions (e.g. when contractually permitted and when participants provide appropriate consent). Individual patient-level data would only be shared following completion of this study (and any associated studies), completion of applicable regulatory submissions, and in accordance with applicable regulations and laws, as well as criteria established by Adverum, our collaborators and/or industry best practices. Shared datasets and/or documents may be de-identified and/or redacted to protect participant identity and to protect sensitive and confidential information. For inquiries, please contact us at datasharing@adverum.com

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj