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New treatment option for Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
Official title Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration
ClinicalTrials.gov ID: NCT07630649
What this study is testing
What is Ixo-vec?
Ixo-vec is an investigational medicine, being studied as a potential treatment for neovascular age-related macular degeneration (namd) wet amd.
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
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
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
- Male or female, aged ≥ 50 years at Screening Visit 1.
- Must agree to use an acceptable form of contraception.
- Have diagnosis of bilateral CNV secondary to nAMD.
- 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...
You likely can't join if
- A/ General Exclusion Criteria
- Have history of a medical condition (systemic disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) giving...
- Received prior gene therapy (other than Ixo-vec, where applicable)
- Currently receiving steroids at Screening Visit 1 in the previously treated eye (Ixo-vec-experienced participants) or in either eye (Ixo-vec-naïve...
- 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...
- Have history of allergy, hypersensitivity, or contraindications to the use of any product or its excipients administered as part of this study.
See the full eligibility criteria
- Male or female, aged ≥ 50 years at Screening Visit 1.
- Must agree to use an acceptable form of contraception.
- Have diagnosis of bilateral CNV secondary to nAMD.
- 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
- Have prior treatment history consistent with protocol-defined requirements, including prior anti-VEGF therapy and, where applicable, prior Ixo-vec exposure.
- 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...
- Able to comply with study procedures according to the Investigator's judgment. Other protocol-defined apply.
- A/ General Exclusion Criteria
- 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...
- Received prior gene therapy (other than Ixo-vec, where applicable)
- Currently receiving steroids at Screening Visit 1 in the previously treated eye (Ixo-vec-experienced participants) or in either eye (Ixo-vec-naïve participants).
- 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
- Have history of allergy, hypersensitivity, or contraindications to the use of any product or its excipients administered as part of this study.
- Have evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0%
- Have history or evidence of cardiovascular diseases and ongoing bleeding disorders as defined by the protocol.
- Use of systemic immunosuppressive therapy within a protocol-defined period.
- Received systemic anti-VEGF therapy within a protocol-defined period.
- 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
- 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).
- 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...
- Have prior ocular surgery or treatment that may confound assessment or increase risk.
- 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...
- Have uncontrolled ocular hypertension or glaucoma as defined by the protocol.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Deerfield Beach, Florida, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- West Columbia, South Carolina, United States
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Deerfield Beach, Florida, United States; Fort Lauderdale, Florida, United States; Jacksonville, Florida, United States; West Columbia, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.