Injection pressure levels for creating blebs during subretinal gene therapy

Retinal damage has been associated with increased injection pressure during subretinal gene therapy delivery in various animal models, yet there are no human clinical data regarding the pressures required to initiate and propagate subretinal blebs. This study characterized the intraoperative pressur...

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Bibliographic Details
Published in:Gene therapy 2022-11, Vol.29 (10-11), p.601-607
Main Authors: Scruggs, Brittni A., Vasconcelos, Huber Martins, Matioli da Palma, Mariana, Kogachi, Katie, Pennesi, Mark E., Yang, Paul, Bailey, Steven T., Lauer, Andreas K.
Format: Article
Language:English
Subjects:
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Age
Animal models
Animals
Biomedical and Life Sciences
Biomedicine
Cell Biology
Gene Expression
Gene Therapy
Genetic Therapy - adverse effects
Genetic Therapy - methods
Human Genetics
Injection
Injections
Nanotechnology
Patients
Pressure
Retina
Retinal Degeneration
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Summary:Retinal damage has been associated with increased injection pressure during subretinal gene therapy delivery in various animal models, yet there are no human clinical data regarding the pressures required to initiate and propagate subretinal blebs. This study characterized the intraoperative pressure levels for subretinal gene therapy delivery across eight retinal conditions. A total of 116 patients with retinal degenerative diseases have been treated with subretinal gene therapy at OHSU-Casey Eye Institute as of June 2020; seventy patients (60.3%) were treated using a pneumatic-assisted subretinal delivery system. All retinal blebs were performed using a 41-gauge injection cannula, and use of a balanced salt solution (BSS) “pre-bleb” prior to gene therapy delivery was performed at the discretion of the surgeon. Patient age and intraoperative data for BSS and vector injections were analyzed in a masked fashion for all patients who received pneumatic-assisted subretinal gene therapy. The median age of the patients was 35 years (range 4–70). No significant differences in injection pressures were found across the eight retinal conditions. In this study, patient age was shown to affect maximum injection pressures required for bleb propagation, and the relationship between age and pressure varied based on retinal condition. These data have important implications in optimizing surgical protocols for subretinal injections.
ISSN:0969-7128
1476-5462
DOI:10.1038/s41434-021-00294-2