Retinal Viral Gene Therapy: Impact of Route of Administration on Serious Adverse Events-A Systematic Review.

ABSTRACT:

Background

To explore the prevalence of serious adverse events (SAEs) associated with retinal viral gene therapy and to examine trends influencing SAE occurrences in human gene therapy surgeries and pre-clinical animal trials.

Methods

Literature review was performed to identify peer-reviewed human and animal studies relevant to viral gene therapy, subretinal injections, and intravitreal injections. For clinical trials and post-approval LUXTURNA studies, only those that examined SAEs were included.

Results

Of included clinical trial studies (n = 31), SAEs were recorded in 51 out of 438 eyes (11.6%) that received subretinal injections and in 11 out of 348 eyes (3.2%) that received intravitreal injections. There were fewer intravitreal-related SAEs and less vision loss c

SUBMITTER: Berger A 

PROVIDER: S-EPMC12596463 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature