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Neovascular (wet) Age-related Macular Degeneration (nAMD) - Healing Genes
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Neovascular (wet) Age-related Macular Degeneration (nAMD)

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RGX-314 Gene Therapy for Neovascular AMD Trial

A Phase I/IIa, Open-label, Multiple-cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Gene Therapy With RGX-314 in Subjects With Neovascular AMD (nAMD)


Phase 1 / 2

DESCRIPTION:

Doctors in CA, MD, MA, TX, TN and PA seek patients with Neovascular (wet) Age-related Macular Degeneration (nAMD) to trial an investigatory gene therapy. Through the delivery system of a genetically modified virus, a new gene will be delivered to the sub-retina in order to produce an antibody against vascular endothelial growth factor (VEGF). Excessive vascular endothelial growth factor (VEGF) causes the symptoms of nAMD, so this therapy may train the eye to produce anti-VEGF antibodies.

Participants will receive a single sub-retinal injection of the engineered virus at 1 of 5 dose levels, then be closely followed for 24 weeks, then long-term follow up continues up to 104 weeks.


PATIENT MUST:

  • Be 50 to 89 years of age
  • Diagnosis of subfoveal CNV secondary to AMD in the study eye receiving prior intravitreal anti-VEGF therapy
  • Not have CNV or macular edema in the study eye secondary to any causes other than AMD

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Subretinal injection to the study eye.
  3. Follow up will continue for 26 to 104 weeks.

LOCATIONS & CONTACTS:
The study locations have not yet been announced.
Contact: Darin Curtiss, PharmD  |  1-866-860-0117  |  [email protected]
 
SPONSORS
Regenxbio Inc.
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03066258

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