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

Overview

Información sobre este estudio

The purpose of this study is to investigate the effectiveness and safety of two doses of RGX-314 administered as a single subretinal injection in the study eye of patients with nAMD, and to evaluate mean change from baseline in best-corrected visual acuity (BCVA) of RGX-314 relative to aflibercept at Week 54.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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 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 in the study eye

5. Uncontrolled glaucoma in the study eye

6. History of intraocular surgery in the study eye within 12 weeks prior to Screening
Visit 1

7. 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.

8. Prior treatment with gene therapy.

9. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack
within the past 6 months.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/17/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Matthew Starr, M.D.

Abierto para la inscripción

Contact information:

Jessica Morgan C.O.A.

(507) 293-9689

Morgan.Jessica@mayo.edu

More information

Publicaciones

Publications are currently not available