Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD study: Ixo-vec
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?
an investigational gene therapy being studied as a potential treatment for neovascular (wet) age‑related macular degeneration (nAMD) is designed to deliver a therapeutic gene to retinal cells so they produce a protein that reduces abnormal blood vessel growth
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 study is testing whether Ixo-vec is safe and works well when given to the second eye of people with wet AMD.
- Who it's for
- You may be able to join if you are 50 or older, have wet AMD in both eyes, and may have already had Ixo-vec in one eye.
- What's involved
- You would receive a single injection of Ixo-vec into your other eye. You will have regular check‑ups to see how safe it is and how well it works.
- Time commitment
- The study lasts about 5 years with visits at the start and several follow‑up appointments over 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.
- For Ixo-vec-experienced participants: Contralateral eye has an ETDRS BCVA letter score within a protocol-defined range appropriate for nAMD clinical...
- For Ixo-vec-naïve participants: Both the initial eye and contralateral eye have ETDRS BCVA letter score within a protocol-defined range appropriate...
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.
- 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).
- 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 is enrolling
- Phoenix, Arizona, United States
- Bakersfield, California, United States
- Fullerton, California, United States
- Deerfield Beach, Florida, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- ‘Aiea, Hawaii, United States
- Lemont, Illinois, United States
- Teaneck, New Jersey, United States
- West Columbia, South Carolina, United States
- The Woodlands, Texas, 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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Bakersfield, California, United States; Fullerton, California, United States; Deerfield Beach, Florida, United States; Fort Lauderdale, Florida, United States; Jacksonville, Florida, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.