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Studio sull'Efficacia e Sicurezza di Ixoberogene Soroparvovec (Ixo-vec) in Partecipanti con Degenerazione Maculare Legata all'Età Neovascolare (AQUARIUS) (AQUARIUS)

22 settembre 2026 aggiornato da: Adverum Biotechnologies, Inc.

Uno studio multicentrico, randomizzato, in doppio cieco, controllato con comparatore attivo, di Fase 3 per valutare l'efficacia e la sicurezza di Ixoberogene Soroparvovec (Ixo-vec) in partecipanti con degenerazione maculare legata all'età neovascolare (AQUARIUS)

This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to intravitreal aflibercept (active comparator). The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured as an average at Weeks 52 and 56.

Safety, tolerability, and efficacy will be evaluated throughout the study.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The primary objective of this study is to evaluate the non-inferiority in efficacy of a single IVT injection of Ixo-vec 6 x 10^10 vector genome (vg)/eye compared to an active comparator. Non-inferiority will be evaluated using a pre-specified margin defined in the protocol.

Neovascular AMD 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 IVT injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. Ixo-vec (also known as ADVM-022 or AAV.7m8-aflibercept) is an adeno-associated virus (AAV)-based gene therapy product being developed for the treatment of nAMD. Ixo-vec 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.

Safety, tolerability, and efficacy will be evaluated throughout this study. The primary endpoint of this study is the mean change in BCVA of Ixo-vec compared to an active comparator measured as an average at Weeks 52 and 56 post-treatment.

Due to the long duration of the Screening period, this study will be considered fully enrolled when randomization has been completed.

Tipo di studio

Interventistico

Iscrizione (Stimato)

534

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Mesa, Arizona, Stati Uniti, 85206
        • Reclutamento
        • Adverum Clinical Site 245
      • Phoenix, Arizona, Stati Uniti, 85020
        • Reclutamento
        • Adverum Clinical Site 178
      • Phoenix, Arizona, Stati Uniti, 85014
        • Reclutamento
        • Adverum Clinical Site 126
      • Phoenix, Arizona, Stati Uniti, 85020
        • Reclutamento
        • Adverum Clinical Site 223
      • Scottsdale, Arizona, Stati Uniti, 85255
        • Reclutamento
        • Adverum Clinical Site 229
      • Sun City, Arizona, Stati Uniti, 85351
        • Reclutamento
        • Adverum Clinical Site 242
    • Arkansas
      • Springdale, Arkansas, Stati Uniti, 72764
        • Reclutamento
        • Adverum Clinical Site 198
    • California
      • Bakersfield, California, Stati Uniti, 93309
        • Reclutamento
        • Adverum Clinical Site 109
      • Beverly Hills, California, Stati Uniti, 90211
        • Reclutamento
        • Adverum Clinical Site 100
      • Campbell, California, Stati Uniti, 95008
        • Reclutamento
        • Adverum Clinical Site 201
      • Encino, California, Stati Uniti, 91436
        • Reclutamento
        • Adverum Clinical Site 172
      • Fullerton, California, Stati Uniti, 92835
        • Reclutamento
        • Adverum Clinical Site 169
      • Huntington Beach, California, Stati Uniti, 92647
        • Reclutamento
        • Adverum Clinical Site 224
      • Poway, California, Stati Uniti, 92064
        • Reclutamento
        • Adverum Clinical Site 130
      • Redlands, California, Stati Uniti, 92374
        • Reclutamento
        • Adverum Clinical Site 215
      • Sacramento, California, Stati Uniti, 95825
        • Reclutamento
        • Adverum Clinical Site 140
      • Sacramento, California, Stati Uniti, 95841
        • Reclutamento
        • Adverum Clinical Site 212
      • Santa Barbara, California, Stati Uniti, 93103
        • Reclutamento
        • Adverum Clinical Site 175
      • Torrance, California, Stati Uniti, 90503
        • Reclutamento
        • Adverum Clinical Site 202
      • Walnut Creek, California, Stati Uniti, 94598
        • Reclutamento
        • Adverum Clinical Site 189
    • Colorado
      • Denver, Colorado, Stati Uniti, 80207
        • Reclutamento
        • Adverum Clinical Site 116
      • Denver, Colorado, Stati Uniti, 800222
        • Reclutamento
        • Adverum Clinical Site 200
    • Connecticut
      • Waterford, Connecticut, Stati Uniti, 06385
        • Reclutamento
        • Adverum Clinical Site 165
    • Florida
      • Deerfield Beach, Florida, Stati Uniti, 33064
        • Reclutamento
        • Adverum Clinical Site 124
      • Deerfield Beach, Florida, Stati Uniti, 33064
        • Reclutamento
        • Adverum Clinical Site 184
      • Fort Lauderdale, Florida, Stati Uniti, 33308
        • Reclutamento
        • Adverum Clinical Site 176
      • Fort Myers, Florida, Stati Uniti, 33912
        • Reclutamento
        • Adverum Clinical Site 221
      • Gainesville, Florida, Stati Uniti, 32607
        • Reclutamento
        • Adverum Clinical Site 236
      • Lakeland, Florida, Stati Uniti, 33805
        • Reclutamento
        • Adverum Clinical Site 214
      • Miami Springs, Florida, Stati Uniti, 33166
        • Reclutamento
        • Adverum Clinical Site 168
      • Orlando, Florida, Stati Uniti, 32806
        • Reclutamento
        • Adverum Clinical Site 213
      • Plantation, Florida, Stati Uniti, 33324
        • Reclutamento
        • Adverum Clinical Site 206
      • South Miami, Florida, Stati Uniti, 33143
        • Reclutamento
        • Adverum Clinical Site 183
      • St. Petersburg, Florida, Stati Uniti, 33711
        • Reclutamento
        • Adverum Clinical Site 120
      • Tampa, Florida, Stati Uniti, 33609
        • Reclutamento
        • Adverum Clinical Site 148
      • Winter Haven, Florida, Stati Uniti, 33880
        • Reclutamento
        • Adverum Clinical Site 238
    • Georgia
      • Augusta, Georgia, Stati Uniti, 30909
        • Reclutamento
        • Adverum Clinical Site 182
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60616
        • Reclutamento
        • Adverum Clinical Site 246
      • Oak Forest, Illinois, Stati Uniti, 60452
        • Reclutamento
        • Adverum Clinical Site 179
      • Oak Park, Illinois, Stati Uniti, 60304
        • Reclutamento
        • Adverum Clinical Site 207
    • Indiana
      • Carmel, Indiana, Stati Uniti, 46032
        • Reclutamento
        • Adverum Clinical Site 205
      • Carmel, Indiana, Stati Uniti, 46032
        • Reclutamento
        • Adverum Clinical Site 195
      • Carmel, Indiana, Stati Uniti, 46032
        • Reclutamento
        • Adverum Clinical Site 253
    • Maryland
      • Hagerstown, Maryland, Stati Uniti, 21740
        • Reclutamento
        • Adverum Clinical Site 204
      • Hagerstown, Maryland, Stati Uniti, 21740
        • Reclutamento
        • Adverum Clinical Site 197
    • Mississippi
      • Jackson, Mississippi, Stati Uniti, 39202
        • Reclutamento
        • Adverum Clinical Site 216
    • New Jersey
      • Bloomfield, New Jersey, Stati Uniti, 07003
        • Reclutamento
        • Adverum Clinical Site 240
      • Teaneck, New Jersey, Stati Uniti, 07666
        • Reclutamento
        • Adverum Clinical Site 171
    • New York
      • Liverpool, New York, Stati Uniti, 13088
        • Reclutamento
        • Adverum Clinical Site 225
      • Rochester, New York, Stati Uniti, 14620
        • Reclutamento
        • Adverum Clinical Site 244
    • North Carolina
      • Asheville, North Carolina, Stati Uniti, 28803
        • Reclutamento
        • Adverum Clinical Site 196
      • Cary, North Carolina, Stati Uniti, 27511
        • Reclutamento
        • Adverum Clinical Site 234
      • Greensboro, North Carolina, Stati Uniti, 27401
        • Reclutamento
        • Adverum Clinical Site 211
      • Greensboro, North Carolina, Stati Uniti, 27401
        • Reclutamento
        • Adverum Clinical Site 219
      • Hickory, North Carolina, Stati Uniti, 28602
        • Reclutamento
        • Adverum Clinical Site 220
      • Wake Forest, North Carolina, Stati Uniti, 27587
        • Reclutamento
        • Adverum Clinical Site 209
    • Ohio
      • Beachwood, Ohio, Stati Uniti, 44122-5846
        • Reclutamento
        • Adverum Clinical Site 248
      • Cleveland, Ohio, Stati Uniti, 44130
        • Reclutamento
        • Adverum Clinical Site 247
    • Oklahoma
      • Edmond, Oklahoma, Stati Uniti, 73013
        • Reclutamento
        • Adverum Clinical Site 254
    • Oregon
      • Portland, Oregon, Stati Uniti, 97225
        • Reclutamento
        • Adverum Clinical Site 252
    • Pennsylvania
      • Erie, Pennsylvania, Stati Uniti, 16505
        • Reclutamento
        • Adverum Clinical Site 181
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Reclutamento
        • Adverum Clinical Site 110
      • Philadelphia, Pennsylvania, Stati Uniti, 19102
        • Reclutamento
        • Adverum Clinical Site 239
    • South Carolina
      • Bluffton, South Carolina, Stati Uniti, 29910
        • Reclutamento
        • Adverum Clinical Site 241
      • Ladson, South Carolina, Stati Uniti, 29456
        • Reclutamento
        • Adverum Clinical Site 222
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37203
        • Reclutamento
        • Adverum Clinical Site 101
    • Texas
      • Arlington, Texas, Stati Uniti, 76012
        • Reclutamento
        • Adverum Clinical Site 145
      • Austin, Texas, Stati Uniti, 78705
        • Reclutamento
        • Adverum Clinical Site 127
      • Austin, Texas, Stati Uniti, 78750
        • Reclutamento
        • Adverum Clinical Site 243
      • Conroe, Texas, Stati Uniti, 77384
        • Reclutamento
        • Adverum Clinical Site 107
      • Dallas, Texas, Stati Uniti, 75231
        • Reclutamento
        • Adverum Clinical Site 194
      • McAllen, Texas, Stati Uniti, 78503
        • Reclutamento
        • Adverum Clinical Site 162
      • San Antonio, Texas, Stati Uniti, 78240
        • Reclutamento
        • Adverum Clinical Site 185
      • San Marcos, Texas, Stati Uniti, 78666
        • Reclutamento
        • Adverum Clinical Site 232
      • Schertz, Texas, Stati Uniti, 78154
        • Reclutamento
        • Adverum Clinical Site 228
      • The Woodlands, Texas, Stati Uniti, 77384
        • Reclutamento
        • Adverum Clinical Site 231
      • Tyler, Texas, Stati Uniti, 75703
        • Reclutamento
        • Adverum Clinical Site 237
    • Virginia
      • Lynchburg, Virginia, Stati Uniti, 24502
        • Reclutamento
        • Adverum Clinical Site 199
    • Washington
      • Silverdale, Washington, Stati Uniti, 98383
        • Reclutamento
        • Adverum Clinical Site 249

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Able and willing to provide informed consent (or have a legally authorized representative who is able and willing to provide informed consent) prior to any study assessments and procedures and comply with the study requirements and visits.
  2. Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMD disease activity at Screening Visit 1.
  3. At least 50 years old at Screening Visit 1.
  4. An ETDRS BCVA letter score of 35 - 78 (approximate Snellen equivalent of 20/200 to 20/32) in the study eye at Screening Visit 1.
  5. Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening.
  6. Able to reliably use eye drops per protocol.

Exclusion Criteria:

General Exclusion Criteria

  1. History of a medical condition giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant's ability to comply with the planned study activities, 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 (COVID-19) infection may meet this exclusion criterion if, in the opinion of the Investigator, it is likely to lead to any important complications.

  2. Received any prior gene therapy.

  3. Prior treatment with any non-gene therapy investigational medicinal product (IMP) or medical device in the study eye within 3 months of Screening Visit 1 or 5 half-lives of the IMP prior to dosing with Ixo-vec, whichever is longer.

  4. Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future.

  5. History or evidence of any of the following cardiovascular diseases:

    1. Myocardial infarction in the 6-month period prior to Week 1.
    2. Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg during screening.
    3. Stroke in the 6-month period prior to Week 1.

  6. History of ongoing bleeding disorders. The use of aspirin or other anticoagulants (e.g., Factor Xa inhibitors) is permitted.

  7. Use of systemic immunosuppressive drugs within 90 days prior to Screening Visit 1. Short courses of oral corticosteroids are permitted, as well as any inhaled, intra-articular, nasal or dermal steroid use.

  8. Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% during screening.

Ocular Exclusion Criteria

  1. Any active ocular or periocular infection in the study eye from Screening Visit 1.

  2. History or evidence of the following in the study eye:

    1. Intraocular or refractive surgery within 5 months prior to Week 1.
    2. Any previous penetrating keratoplasty or vitrectomy.
    3. Any previous panretinal photocoagulation.
    4. Any previous submacular surgery, other surgical intervention (including port delivery system) or laser treatment for age-related macular degeneration.

  3. Any history or evidence of retinal detachment (with or without repair) or retinal pigment epithelium rip/tear in the study eye, as determined by the Investigator during screening or at Week 1.

  4. Uncontrolled ocular hypertension or glaucoma in the study eye from Screening Visit 1 to Week 1 or current use of ≥ 2 intraocular pressure (IOP) lowering medications or normal tension glaucoma/suspect in the study eye or history of any of the following procedures in the study eye prior to Week 1:

    1. Incisional glaucoma surgery (i.e., glaucoma drainage implant/shunt or trabeculectomy)
    2. Ocular angle-based surgery (i.e., goniotomy or canaloplasty)
    3. Minimally Invasive Glaucoma Surgery (MIGS) in the study eye.
    4. Angle-based glaucoma surgery (e.g., Argon or Selective Laser Trabeculoplasty)

  5. Any history of IOP elevation related to topical steroid administration in either eye.

  6. Any history of uveitis or inflammation (grade trace or above) except mild anticipated post operative inflammation that resolved in either eye.

  7. Any history of treatment with complement inhibitors for geographic atrophy in the study eye.

  8. Known history of ocular herpes simplex virus, varicella-zoster virus, or cytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Ixo-vec

Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a single IVT injection of Ixo-vec 6 x 10^10 vg/eye at Week 1, and sham injections every 8 weeks.
Genetico: Ixo-vec

Ixo-vec will be administered intravitreally.

Droga: Aflibercept

Aflibercept will be administered intravitreally.
Comparatore attivo: Aflibercept

Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a sham injection at Week 1, and aflibercept 2 mg IVT every 8 weeks.
Droga: Aflibercept

Aflibercept will be administered intravitreally.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change from Baseline in BCVA Based on an Average at Weeks 52 and 56
Lasso di tempo: Baseline, Week 52 and Week 56

BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
Baseline, Week 52 and Week 56

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numero medio di iniezioni intravitreali di Aflibercept ricevute
Lasso di tempo: Dalla Settimana 4 alla Settimana 56
Dalla Settimana 4 alla Settimana 56
Percentuale di partecipanti con BCVA di 73 lettere o più dalla settimana 4 alla settimana 56
Lasso di tempo: Dalla settimana 4 alla settimana 56
Dalla settimana 4 alla settimana 56
Percentuale di partecipanti che non hanno ricevuto iniezioni di Aflibercept
Lasso di tempo: Dalla settimana 4 alla settimana 56
Dalla settimana 4 alla settimana 56
Percentuale di partecipanti che hanno ricevuto 0 o 1 iniezione di aflibercept
Lasso di tempo: Dalla settimana 4 alla settimana 56
Dalla settimana 4 alla settimana 56
Percentage of Participants with Worsened BCVA
Lasso di tempo: Through Week 56

BCVA measured by ETDRS.
Through Week 56
Percentage of Participants with Improved BCVA
Lasso di tempo: Through Week 56

BCVA measured by ETDRS.
Through Week 56
Mean Change from Baseline in BCVA Over Time Based on an Average at Weeks 52 and 56
Lasso di tempo: Baseline Through Week 56

BCVA measured by ETDRS.
Baseline Through Week 56
Mean Change from Week 1 in BCVA Based on an Average at Weeks 52 and 56
Lasso di tempo: Week 1 through Week 56

BCVA measured by ETDRS.
Week 1 through Week 56
Mean Change in Central Subfield Thickness (CST) from Baseline Over Time Through Week 56
Lasso di tempo: Baseline Through Week 56

CST as measured by spectral domain optical coherence tomography (SD-OCT).
Baseline Through Week 56
Percentage of Participants with CST ≤ 300 μm Over Time Through Week 56
Lasso di tempo: Through Week 56

CST will be assessed by a central reading center (CRC) using SD-OCT.
Through Week 56
Mean Number of CST Fluctuations > 50 μm From Week 1 Over Time Through Week 56
Lasso di tempo: Week 1 through Week 56

CST will be assessed by a CRC using SD-OCT images and the mean number of fluctuations with thickness of more than 50 μm will be summarized.
Week 1 through Week 56
Percentage of Participants with CST Fluctuations > 50 μm from Week 1 Over Time Through Week 56
Lasso di tempo: Week 1 through Week 56

CST will be assessed using SD-OCT.
Week 1 through Week 56
Percent Reduction in Mean Rate of Annualized Anti-VEGF Injections
Lasso di tempo: Through Week 56

Percent reduction in mean rate of annualized anti-VEGF injections will be assessed relative to the reduction in mean rate of annualized anti-VEGF injections received in the year prior to screening in treatment-experienced participants.
Through Week 56
Mean Change in Area of Choroidal Neovascularization (CNV) Lesion from Baseline Over Time Through Week 56
Lasso di tempo: Baseline through Week 56

CNV is the infiltration of abnormal blood vessels in the retina from the underlying choroid layer. It will be assessed by a CRC using SD-OCT.
Baseline through Week 56
Mean Change in Macular Volume from Baseline Over Time Through Week 56
Lasso di tempo: Baseline through Week 56

Macular volume will be measured as part of the full ophthalmic examination.
Baseline through Week 56
Percentage of Participants Without Intraretinal Fluid (IRF) Over Time Through Week 56
Lasso di tempo: Through Week 56

IRF will be assessed using SD-OCT.
Through Week 56
Percentage of Participants Without Subretinal Fluid (SRF) Over Time Through Week 56
Lasso di tempo: Through Week 56

SRF will be assessed using SD-OCT.
Through Week 56
Percentage of Participants Without IRF and/or SRF Over Time Through Week 56
Lasso di tempo: Through Week 56

IRF and SRF will be assessed using SD-OCT.
Through Week 56
Time to Dry Retina
Lasso di tempo: Through Week 56

Dry retina is defined as no IRF or SRF (i.e., absence of both). IRF and SRF will be assessed using SD-OCT.
Through Week 56
Time to Sustained Dry Retina
Lasso di tempo: Through Week 56

Sustained dry retina is defined as no IRF or SRF (i.e., absence of both) maintained for 2 consecutive visits.
Through Week 56
Number of Participants Who Experienced Ocular Adverse Events
Lasso di tempo: Through Week 56

The number of participants who experience an ocular adverse event will be summarized.
Through Week 56
Number of Participants Who Experienced Mild, Moderate or Severe Ocular Adverse Events
Lasso di tempo: Through Week 56

The number of participants who experience a mild, moderate or severe ocular adverse event will be summarized.
Through Week 56
Number of Participants Who Experienced Non-ocular Adverse Events
Lasso di tempo: Through Week 56

The number of participants who experience a non-ocular adverse event will be summarized.
Through Week 56
Number of Participants Who Experienced Mild, Moderate or Severe Non-ocular Adverse Events
Lasso di tempo: Through Week 56

The number of participants who experience a mild, moderate or severe non-ocular adverse event will be summarized.
Through Week 56
Mean Change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Total and Subscale Scores
Lasso di tempo: Day 1 to Week 28 and Week 56

The NEI VFQ-25 measures vision-targeted patient-reported outcomes of individuals with chronic eye diseases. It comprises 25 questions. The assessment generates an overall composite score and includes the following subscales: global vision rating, difficulty with near vision activities, difficulty with distance vision activities, limitations in social functioning due to vision, role limitations due to vision, dependency on others due to vision, mental health symptoms due to vision, driving difficulties, limitations with peripheral and color vision, and ocular pain. A decrease in the NEI VFQ-25 score represents an improvement in disease severity.
Day 1 to Week 28 and Week 56
Mean Change in the 5-item Health-related Quality of Life Questionnaire (EQ-5D-5L)
Lasso di tempo: Day 1 to Week 28 and Week 56

The EQ-5D-5L is a concise, generic self-reported health questionnaire which is weighted to reflect the relevant importance to patients of various different health problems. In retinal disease, the questionnaire is used to assess quality of life in the context of vision loss. It measures five parameters; mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the EQ-5D-5L score represents an improvement in disease severity.
Day 1 to Week 28 and Week 56

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Adverum Biotechnologies, Inc.

Investigatori

  • Direttore dello studio: Adam Turpcu, PhD, Adverum Biotechnologies, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 marzo 2026

Completamento primario (Stimato)

15 novembre 2027

Completamento dello studio (Stimato)

20 ottobre 2031

Date di iscrizione allo studio

Primo inviato

16 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 marzo 2026

Primo Inserito (Effettivo)

19 marzo 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ADVM-022-13

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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