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Résztvevőt keres itt: Egyesült Államok3. fázis

Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)

A legfontosabb adatok

Hol
Arlington, Asheville, Augusta, Austin, Bakersfield, Beachwood, Beverly Hills, Bloomfield, Bluffton, Campbell, Carmel, Cary, Chicago, Cleveland, Conroe, Dallas, Deerfield Beach, Denver, Edmond, Encino, Erie, Fort Lauderdale, Fort Myers, Fullerton, Gainesville, Greensboro, Hagerstown, Hickory, Huntington Beach, Jackson, Ladson, Lakeland, Liverpool, Lynchburg, McAllen, Mesa, Miami Springs, Nashville, Oak Forest, Oak Park, Orlando, Philadelphia, Phoenix, Plantation, Portland, Poway, Redlands, Rochester, Sacramento, San Antonio, San Marcos, Santa Barbara, Schertz, Scottsdale, Silverdale, South Miami, Springdale, St. Petersburg, Sun City, Tampa, Teaneck, The Woodlands, Torrance, Tyler, Wake Forest, Walnut Creek, Waterford és Winter Haven (Egyesült Államok)Mind a 79 helyszín megnézése
Fázis
3. fázis

AI-kivonat: kiket keres a vizsgálat

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat 50 éves vagy idősebb, nedves típusú időskori makuladegenerációban (nAMD) szenvedő felnőtteket keres, akiket még nem kezeltek, vagy már kezeltek korábban. Egyetlen szembe adott Ixo-vec injekciót hasonlít össze az aflibercepttel.

Életkor
Legalább 50 év
Nem
Férfiak és nők is részt vehetnek
A betegség stádiuma
A vizsgált szemben nAMD miatti CNV (új, kóros erek), a szűréskor aktív betegséggel. A látásélességi betűpontszám 35 - 78 (kb. 20/200 – 20/32) ebben a szemben.
Korábbi kezelés
A szűrés alatt az anti-VEGF kezelésre érdemi anatómiai választ kellett mutatnia. Korábban nem kaphatott génterápiát.

A részvétel fő kizáró okai

  • Korábbi génterápia
  • Terhesség vagy szoptatás, illetve terhesség vagy szoptatás tervezése
  • Szívinfarktus vagy agyi érkatasztrófa (stroke) az 1. hét előtti 6 hónapban, vagy nem kezelt magas vérnyomás
  • Rosszul beállított cukorbetegség (HbA1c 8.0% (64 mmol/mol) vagy magasabb)
  • Szisztémás immunszuppresszív gyógyszerek a 1. szűrővizit előtti 90 napon belül

Gépi kiolvasás: 2026. november 9.

Helyszínek itt: Egyesült Államok

  • Arlington, TexasHospital not named in the registryRésztvevőt keres
  • Asheville, North CarolinaHospital not named in the registryRésztvevőt keres
  • Augusta, GeorgiaHospital not named in the registryRésztvevőt keres
  • Austin, TexasHospital not named in the registryRésztvevőt keres
  • Austin, TexasHospital not named in the registryRésztvevőt keres
  • Bakersfield, CaliforniaHospital not named in the registryRésztvevőt keres
  • Beachwood, OhioHospital not named in the registryRésztvevőt keres
  • Beverly Hills, CaliforniaHospital not named in the registryRésztvevőt keres
  • Bloomfield, New JerseyHospital not named in the registryRésztvevőt keres
  • Bluffton, South CarolinaHospital not named in the registryRésztvevőt keres
  • Campbell, CaliforniaHospital not named in the registryRésztvevőt keres
  • Carmel, IndianaHospital not named in the registryRésztvevőt keres
  • Carmel, IndianaHospital not named in the registryRésztvevőt keres
  • Carmel, IndianaHospital not named in the registryRésztvevőt keres
  • Cary, North CarolinaHospital not named in the registryRésztvevőt keres
  • Chicago, IllinoisHospital not named in the registryRésztvevőt keres
  • Cleveland, OhioHospital not named in the registryRésztvevőt keres
  • Conroe, TexasHospital not named in the registryRésztvevőt keres
  • Dallas, TexasHospital not named in the registryRésztvevőt keres
  • Deerfield Beach, FloridaHospital not named in the registryRésztvevőt keres
  • Deerfield Beach, FloridaHospital not named in the registryRésztvevőt keres
  • Denver, ColoradoHospital not named in the registryRésztvevőt keres
  • Denver, ColoradoHospital not named in the registryRésztvevőt keres
  • Edmond, OklahomaHospital not named in the registryRésztvevőt keres
  • Encino, CaliforniaHospital not named in the registryRésztvevőt keres
  • Erie, PennsylvaniaHospital not named in the registryRésztvevőt keres
  • Fort Lauderdale, FloridaHospital not named in the registryRésztvevőt keres
  • Fort Myers, FloridaHospital not named in the registryRésztvevőt keres
  • Fullerton, CaliforniaHospital not named in the registryRésztvevőt keres
  • Gainesville, FloridaHospital not named in the registryRésztvevőt keres
  • Greensboro, North CarolinaHospital not named in the registryRésztvevőt keres
  • Greensboro, North CarolinaHospital not named in the registryRésztvevőt keres
  • Hagerstown, MarylandHospital not named in the registryRésztvevőt keres
  • Hagerstown, MarylandHospital not named in the registryRésztvevőt keres
  • Hickory, North CarolinaHospital not named in the registryRésztvevőt keres
  • Huntington Beach, CaliforniaHospital not named in the registryRésztvevőt keres
  • Jackson, MississippiHospital not named in the registryRésztvevőt keres
  • Ladson, South CarolinaHospital not named in the registryRésztvevőt keres
  • Lakeland, FloridaHospital not named in the registryRésztvevőt keres
  • Liverpool, New YorkHospital not named in the registryRésztvevőt keres
  • Lynchburg, VirginiaHospital not named in the registryRésztvevőt keres
  • McAllen, TexasHospital not named in the registryRésztvevőt keres
  • Mesa, ArizonaHospital not named in the registryRésztvevőt keres
  • Miami Springs, FloridaHospital not named in the registryRésztvevőt keres
  • Nashville, TennesseeHospital not named in the registryRésztvevőt keres
  • Oak Forest, IllinoisHospital not named in the registryRésztvevőt keres
  • Oak Park, IllinoisHospital not named in the registryRésztvevőt keres
  • Orlando, FloridaHospital not named in the registryRésztvevőt keres
  • Philadelphia, PennsylvaniaHospital not named in the registryRésztvevőt keres
  • Philadelphia, PennsylvaniaHospital not named in the registryRésztvevőt keres
  • Phoenix, ArizonaHospital not named in the registryRésztvevőt keres
  • Phoenix, ArizonaHospital not named in the registryRésztvevőt keres
  • Phoenix, ArizonaHospital not named in the registryRésztvevőt keres
  • Plantation, FloridaHospital not named in the registryRésztvevőt keres
  • Portland, OregonHospital not named in the registryRésztvevőt keres
  • Poway, CaliforniaHospital not named in the registryRésztvevőt keres
  • Redlands, CaliforniaHospital not named in the registryRésztvevőt keres
  • Rochester, New YorkHospital not named in the registryRésztvevőt keres
  • Sacramento, CaliforniaHospital not named in the registryRésztvevőt keres
  • Sacramento, CaliforniaHospital not named in the registryRésztvevőt keres
  • San Antonio, TexasHospital not named in the registryRésztvevőt keres
  • San Marcos, TexasHospital not named in the registryRésztvevőt keres
  • Santa Barbara, CaliforniaHospital not named in the registryRésztvevőt keres
  • Schertz, TexasHospital not named in the registryRésztvevőt keres
  • Scottsdale, ArizonaHospital not named in the registryRésztvevőt keres
  • Silverdale, WashingtonHospital not named in the registryRésztvevőt keres
  • South Miami, FloridaHospital not named in the registryRésztvevőt keres
  • Springdale, ArkansasHospital not named in the registryRésztvevőt keres
  • St. Petersburg, FloridaHospital not named in the registryRésztvevőt keres
  • Sun City, ArizonaHospital not named in the registryRésztvevőt keres
  • Tampa, FloridaHospital not named in the registryRésztvevőt keres
  • Teaneck, New JerseyHospital not named in the registryRésztvevőt keres
  • The Woodlands, TexasHospital not named in the registryRésztvevőt keres
  • Torrance, CaliforniaHospital not named in the registryRésztvevőt keres
  • Tyler, TexasHospital not named in the registryRésztvevőt keres
  • Wake Forest, North CarolinaHospital not named in the registryRésztvevőt keres
  • Walnut Creek, CaliforniaHospital not named in the registryRésztvevőt keres
  • Waterford, ConnecticutHospital not named in the registryRésztvevőt keres
  • Winter Haven, FloridaHospital not named in the registryRésztvevőt keres

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

A vizsgálat adatai

Ki végzi
Adverum Biotechnologies, Inc.
Azonosító
NCT07482176
A regiszteradat frissítve
2026. szeptember 24.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

A Multi-center, Randomized, Double-masked, Active-comparator-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (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.

Bevonási feltételek: 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; Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMD disease activity at Screening Visit 1; At least 50 years old at Screening Visit 1; 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; Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening; Able to reliably use eye drops per protocol.

Kizáró feltételek: Received any prior gene therapy; 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; History or evidence of any of the following cardiovascular diseases:; Myocardial infarction in the 6-month period prior to Week 1; Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg during screening; Stroke in the 6-month period prior to Week 1; 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; History or evidence of the following in the study eye:; Intraocular or refractive surgery within 5 months prior to Week 1; Any previous penetrating keratoplasty or vitrectomy; Any previous panretinal photocoagulation; Any previous submacular surgery, other surgical intervention (including port delivery system) or laser treatment for age-related macular degeneration; 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:; Incisional glaucoma surgery (i.e., glaucoma drainage implant/shunt or trabeculectomy); Ocular angle-based surgery (i.e., goniotomy or canaloplasty); Minimally Invasive Glaucoma Surgery (MIGS) in the study eye; Angle-based glaucoma surgery (e.g., Argon or Selective Laser Trabeculoplasty); Any history of treatment with complement inhibitors for geographic atrophy in the study eye; 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; History of ongoing bleeding disorders. The use of aspirin or other anticoagulants (e.g., Factor Xa inhibitors) is permitted; Any active ocular or periocular infection in the study eye from Screening Visit 1; Any history of IOP elevation related to topical steroid administration in either eye; Any history of uveitis or inflammation (grade trace or above) except mild anticipated post operative inflammation that resolved in either eye; Known history of ocular herpes simplex virus, varicella-zoster virus, or cytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye; Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% during screening; Ocular Exclusion Criteria; General Exclusion Criteria; Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future; 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.

ClinicalTrials.gov NCT07482176