Injection pressure levels for creating blebs during subretinal gene therapy
Open accessAbstract
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.
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Propagation of the subretinal bleb with vector requires higher injection pressures in children.
“Propagation of the sub retinal bleb with vector requires higher injection pressures in children (Scruggs et al., 2022).”
From Gene Therapy-Associated Uveitis (GTAU): Understanding and mitigating the adverse immune response in retinal gene therapy (2025) · cites this paper as Scruggs et al., 2022
The Results (Subretinal bleb formation) report that patients aged 4–20 required significantly higher vector-propagation pressures than patients over 55. But the Age and condition Results say the relationship varied by retinal condition, with older patients requiring higher pressures for condition F. The unqualified claim about children therefore overgeneralizes the finding. (LLM, conf=0.87)
Experimental — accuracy not yet measuredA two-step subretinal injection, initiating a small pre-bleb with balanced saline solution followed by slow propagation with viral vector, allows bleb propagation at a lower injection pressure than one-step injection.
“A different approach to subretinal injection is a 'two-step ' injection with initiation of a small 'pre-bleb ' using balanced saline solution (BSS) followed by slow propagation of the bleb using the viral vector (MacLaren et al., 2014). A considerable advantage of two-step injection is that it allows bleb propagation at a lower injection pressure (Scruggs et al., 2022).”
From Gene Therapy-Associated Uveitis (GTAU): Understanding and mitigating the adverse immune response in retinal gene therapy (2025) · cites this paper as Scruggs et al., 2022
The Results (Subretinal bleb formation; page not provided) report that vector propagation after a BSS pre-bleb required a lower minimum pressure than pre-bleb formation (4 versus 5 psi). The Discussion also describes relatively low propagation pressures with prolonged injection time. The paper does not establish that two-step injection requires less pressure than one-step injection; its reported comparison is between the two stages of the two-step procedure. (LLM, conf=0.86)
Experimental — accuracy not yet measuredTriamcinolone acetonide may also be used to visualise the posterior hyaloid for posterior vitreous detachment induction prior to subretinal injection.
“As mentioned above, triamcinolone acetonide may also be used to visualise the posterior hyaloid for PVD induction prior to subretinal injection (Dimopoulos et al., 2018; Scruggs et al., 2022; Michaelides et al., 2024).”
From Gene Therapy-Associated Uveitis (GTAU): Understanding and mitigating the adverse immune response in retinal gene therapy (2025) · cites this paper as Scruggs et al., 2022
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References 13 · Cited by 28
- Authors
- Scruggs, B. A., Vasconcelos, H. M., Matioli da Palma, M., Kogachi, K., Pennesi, M. E., Yang, P., Bailey, S. T., & Lauer, A. K.
- Affiliations
- Mayo Clinic (US)
- Oregon Health & Science University (US)
- Corresponding author
- Lauer, Andreas K.
- ORCID
- Venue
- Gene Therapy
- Published
- 2021-09-28
- Volume
- 29
- Issue
- 10-11
- Pages
- 601-607
- ISSN
- 0969-7128 (ISSN-L)
- 1476-5462
- PMC
- PMC8958181
- OpenAlex
- W3203516289
- Cited by
- 28
- References
- 13
- Citations by year
- 2026: 9 · 2025: 9 · 2024: 4 · 2023: 5 · 2022: 1
- FWCI
- 0.78
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- Gene Therapy (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Heed Ophthalmic Foundation (Heed Fellowship Award)
- Foundation Fighting Blindness (CD-NMT-0714-0648)
- U.S. Department of Health & Human Services | National Institutes of Health (K08EY026650, P30EY010572)
- Research to Prevent Blindness (Unrestricted grant to the Casey Eye Institute Department of Ophthalmology)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinal Development and Disorders
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Keywords
- subretinal gene therapy, injection pressure, retinal degeneration, patient age, balanced salt solution
- MeSH terms
- Animals, Injections, Retina, Retinal Degeneration, Genetic Therapy
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