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NCT04912843Possibly a fitRecruiting

Gene therapy for inherited optic nerve vision loss

Leber's Hereditary Optic Neuropathy (LHON)

Part of Brain & nervous system, Eyes & vision, Genetic & congenital, Hormones & metabolism clinical trials.

This trial tests a gene therapy injection into the eye to improve vision in people with a specific type of inherited optic nerve disease called Leber’s hereditary optic neuropathy (LHON). It is aimed at people who have a particular genetic change and a history of vision loss lasting long enough to measure change, while checking for safety first.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
102 people
Ages
12 years to 75 years
Study type
Interventional

Who can take part

  • Be between 18 and 75 years old (or between 12 and 75 for a safety/monitoring group).
  • Have LHON vision loss in at least one eye, and your vision test result must meet the trial’s minimum level.
  • Confirm you have the LHON genetic mutation called G11778A in the ND4 gene, with no other specific LHON mutations.
  • The worse-vision eye must have had vision loss for more than 6 months but less than 10 years.
  • Agree to consent and follow the study rules, including eye exam needs (your pupils must be able to be dilated for testing).
  • If you are male or female who could become pregnant, follow the trial’s pregnancy-prevention and breastfeeding rules for at least 6 months after treatment.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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