Is NCT07630649 recruiting in Deerfield Beach, FL?

Yes, NCT07630649 is currently recruiting participants at its Deerfield Beach, FL location. This neovascular age-related macular degeneration (namd) wet amd clinical trial is actively enrolling qualified participants.

Is participation in this Deerfield Beach clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD Clinical Trial in Deerfield Beach, FL

Q: How do I join the neovascular age-related macular degeneration (namd) wet amd clinical trial in Deerfield Beach?

To join this clinical trial in Deerfield Beach, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD Study in Deerfield Beach

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. This study focuses on how the treatment works when both eyes are treated at different times and how effective and long-lasting Ixo-vec treatment is in the second (contralateral) eye. Participants will receive a single administration of Ixo-vec in the contralateral eye and will be followed for approximately 5 years to evaluate safety, efficacy and durability of contralateral treatment. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy. The study is intended to provide additional information on the safety, tolerability, and use of Ixo-vec in bilateral treatment.

Sponsor: Adverum Biotechnologies, Inc.

Who Can Participate

Inclusion 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 defined in the protocol.

Able to comply with study procedures according to the Investigator's judgment. Other protocol-defined INCLUSION CRITERIA apply.

Exclusion Criteria

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 Ixo-vec, compromises the participant's ability to comply with the planned study assessments, 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 of 2019 (COVID-19) infection may meet this exclusion criterion if, in the opinion of the Investigator, it is likely to lead to any of the complications listed above.

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, in the judgment of the Investigator, could reduce the potential for visual improvement, confound assessment of the macula or require medical or surgical intervention during the study.

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 determined by the Investigator.

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 intraocular inflammation. Enrollment of a participant with prior anterior chamber cell or vitreous cell ≥2+ in the initial eye requires discussion with the medical monitor. Other protocol-defined EXCLUSION CRITERIA apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Deerfield Beach?

Yes, this clinical trial (NCT07630649) has an active research site in Deerfield Beach, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD Treatment Options in Deerfield Beach, FL

If you're searching for neovascular age-related macular degeneration (namd) wet amd treatment options in Deerfield Beach, FL, this clinical trial (NCT07630649) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Deerfield Beach research site is actively enrolling participants for this clinical trial. You'll receive care from experienced neovascular age-related macular degeneration (namd) wet amd specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all neovascular age-related macular degeneration (namd) wet amd clinical trials near you to find additional studies recruiting in your area.

Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD Clinical Trial in Deerfield Beach, FL

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