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Tests treatment safety and results for Neovascular Age-Related Macular Degeneration (nAMD)
Official title Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)
ClinicalTrials.gov ID: NCT07482176
What this study is testing
What is Ixo-vec?
Ixo-vec is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neovascular age-related macular degeneration (namd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Able and willing to provide informed consent (or have a legally authorized representative who is able and willing to provide informed consent) prior...
- 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.
You likely can't join if
- General Exclusion Criteria
- History of a medical condition giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant's...
- 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...
- Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future.
- History or evidence of any of the following cardiovascular diseases:
See the full eligibility criteria
- 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...
- 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.
- General Exclusion Criteria
- 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...
- 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...
- Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future.
- 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.
- History of ongoing bleeding disorders. The use of aspirin or other anticoagulants (e.g., Factor Xa inhibitors) is permitted.
- 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.
- Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% during screening. Ocular Exclusion Criteria
- Any active ocular or periocular infection in the study eye from Screening Visit 1.
- 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.
- 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.
- 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...
- 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 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.
- Any history of treatment with complement inhibitors for geographic atrophy in the study eye.
- Known history of ocular herpes simplex virus, varicella-zoster virus, or cytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye.
The study team makes the final eligibility decision.
Where it's taking place
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Sun City, Arizona, United States
- Springdale, Arkansas, United States
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Campbell, California, United States
- Encino, California, United States
- Fullerton, California, United States
- Huntington Beach, California, United States
- Poway, California, United States
- Redlands, California, United States
- Sacramento, California, United States
- Santa Barbara, California, United States
- Torrance, California, United States
- Walnut Creek, California, United States
- Denver, Colorado, United States
- Waterford, Connecticut, United States
- Deerfield Beach, Florida, United States
+ 48 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mesa, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Sun City, Arizona, United States; Springdale, Arkansas, United States; Bakersfield, California, United States and 62 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.