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Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

AMD | Wet Age-related Macular Degeneration | WetAMD | CNV | nAMD | wAMD

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    50 to 89

Critères de participation

Inclusion Criteria:

1. Age ≥ 50 years and ≤ 89 years
2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
3. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF
4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye
5. Willing and able to provide written, signed informed consent for this study
6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to any causes other than AMD
2. Subfoveal fibrosis or atrophy in the study eye
3. Any condition in the investigator's opinion that could limit VA improvement in the study eye
4. Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
5. Advanced glaucoma or history of secondary glaucoma in the study eye
6. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
7. History of intraocular surgery in the study eye within 12 weeks prior to randomization
8. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1.
9. Prior treatment with gene therapy.

Lieu de l'étude

University of British Columbia - Eye Care Centre, Vancouver General Hospital
University of British Columbia - Eye Care Centre, Vancouver General Hospital
Vancouver, British Columbia
Canada

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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

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Alberta Retina Consultants
Alberta Retina Consultants
Edmonton, Alberta
Canada

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Retina Centre of Ottawa
Retina Centre of Ottawa
Ottawa, Ontario
Canada

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Toronto Retina Institute
Toronto Retina Institute
North York, Ontario
Canada

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Calgary Retina Consultants
Calgary Retina Consultants
Calgary, Alberta
Canada

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Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Ottawa, Ontario
Canada

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Étude parrainée par
AbbVie
Participants recherchés
Plus d'informations
ID de l'étude: NCT05407636