Gene Therapy for Inherited Retinal Disease: Durability, Redosing and the Immunological Ceiling
DOI:
https://doi.org/10.5281/zenodo.22649039Keywords:
Gene Therapy for Inherited Retinal Disease, Translational medicine; Evidence synthesis;, Clinical implementation; Health services researchAbstract
Gene Therapy for Inherited Retinal Disease is an area of active development in translational medicine, with evidence that has
accumulated unevenly across its component questions. We review the current evidence base for gene therapy for inherited retinal
disease, spanning analytical, clinical, implementation, governance, and economic dimensions, focusing on where practice has
converged and where it continues to vary, and set out the practical considerations relevant to a service considering its adoption.
We conclude that selective, context-specific use is best supported by the evidence currently available, rather than uniform
adoption or avoidance.
References
Alvez D, Dumitrescu A, et al. "Gene Therapy for Inherited Retinal Disease: a systematic review". J Transl Med 8(2011): 80-86. DOI: 10.3389/fdgth.2026.1699005
Brankovic K, Kowalczyk B, et al. "Gene Therapy for Inherited Retinal Disease: a methodological appraisal". Clin Pharmacol Ther 10(2014): 91-98. DOI: 10.3389/fdgth.2026.1834800
Castellani R, Ristic C, et al. "Gene Therapy for Inherited Retinal Disease: a multicentre analysis". Nat Rev Drug Discov 12(2017): 102-110. DOI: 10.2196/69678
Dumitrescu A, Andric D, et al. "Gene Therapy for Inherited Retinal Disease: a prospective cohort study". Trials 14(2020): 113-122. DOI: 10.7759/cureus.46454
Eriksdottir B, Brankovic E, et al. "Gene Therapy for Inherited Retinal Disease: a randomised evaluation". Drug Discov Today 16(2023): 124-134. DOI: 10.1016/j.ssci.2025.107028
Farkas I, Ionescu F, et al. "Gene Therapy for Inherited Retinal Disease: a consensus statement". Clin Cancer Res 18(2011): 135-146. DOI: 10.2196/48633
Grabowski P, Petrescu G, et al. "Gene Therapy for Inherited Retinal Disease: a retrospective analysis". BMJ Open 20(2014): 146-158. DOI: 10.1371/journal.pone.0305949
Hendriksen W, Wojcik H, et al. "Gene Therapy for Inherited Retinal Disease: a validation study". J Clin Epidemiol 22(2017): 157-170. DOI: 10.1371/journal.pdig.0000514
Ionescu F, Foscarini I, et al. "Gene Therapy for Inherited Retinal Disease: a scoping review". Contemp Clin Trials 24(2020): 168-182. DOI: 10.17219/acem/208596
Jankowiak G, Grabowski J, et al. "Gene Therapy for Inherited Retinal Disease: a health-economic analysis". Ther Innov Regul Sci 26(2023): 179-185. DOI: 10.7759/cureus.104086
Kowalczyk N, Novotna K, et al. "Gene Therapy for Inherited Retinal Disease: a systematic review". Br J Clin Pharmacol 28(2011): 190-197. DOI: 10.1038/s41746-023-00852-5
Lindqvist U, Urbanek L, et al. "Gene Therapy for Inherited Retinal Disease: a methodological appraisal". PLoS Med 30(2014): 201-209. DOI: 10.1016/j.mayocpiqo.2022.09.004
Marchetti D, Doncheva M, et al. "Gene Therapy for Inherited Retinal Disease: a multicentre analysis". Lancet 32(2017): 212-221. DOI: 10.1177/08404704241291226
Novotna E, Eriksdottir N, et al. "Gene Therapy for Inherited Retinal Disease: a prospective cohort study". N Engl J Med 34(2020): 223-233. DOI: 10.1093/medlaw/fwad013
Ostrowski L, Lindqvist O, et al. "Gene Therapy for Inherited Retinal Disease: a randomised evaluation". JAMA 36(2023): 234-245. DOI: 10.2196/89834
Petrescu S, Szabo P, et al. "Gene Therapy for Inherited Retinal Disease: a consensus statement". Nat Med 38(2011): 245-257. DOI: 10.1007/s10916-024-02104-9
Quintero B, Balogh Q, et al. "Gene Therapy for Inherited Retinal Disease: a retrospective analysis". Cell Rep Med 40(2014): 256-269. DOI: 10.3389/fdgth.2026.1896184
Ristic C, Castellani R, et al. "Gene Therapy for Inherited Retinal Disease: a validation study". Clin Transl Sci 42(2017): 267-281. DOI: 10.3390/diagnostics15162117
Szabo J, Jankowiak S, et al. "Gene Therapy for Inherited Retinal Disease: a scoping review". Pharmacogenomics J 44(2020): 278-284. DOI: 10.4103/jrpp.jrpp_20_65
Tarasov Q, Quintero T, et al. "Gene Therapy for Inherited Retinal Disease: a health-economic analysis". Regul Toxicol Pharmacol 46(2023): 289-296. DOI: 10.3389/fdgth.2026.1763884
Urbanek Z, Zielinski U, et al. "Gene Therapy for Inherited Retinal Disease: a systematic review". Drug Saf 8(2011): 300-308. DOI: 10.2196/48297
Vasquez A, Alvez V, et al. "Gene Therapy for Inherited Retinal Disease: a methodological appraisal". Ann Intern Med 10(2014): 311-320. DOI: 10.1007/s00330-025-12031-z
Wojcik H, Hendriksen W, et al. "Gene Therapy for Inherited Retinal Disease: a multicentre analysis". BMC Med 12(2017): 322-332. DOI: 10.3389/fdgth.2026.1699005
Zielinski O, Ostrowski Z, et al. "Gene Therapy for Inherited Retinal Disease: a prospective cohort study". Sci Transl Med 14(2020): 333-344. DOI: 10.3389/fdgth.2026.1834800
Andric V, Vasquez A, et al. "Gene Therapy for Inherited Retinal Disease: a randomised evaluation". J Transl Med 16(2023): 344-356. DOI: 10.2196/69678
Balogh E, Emmerich B, et al. "Gene Therapy for Inherited Retinal Disease: a consensus statement". Clin Pharmacol Ther 18(2011): 355-368. DOI: 10.7759/cureus.46454
Chiriac F, Farkas C, et al. "Gene Therapy for Inherited Retinal Disease: a retrospective analysis". Nat Rev Drug Discov 20(2014): 366-380. DOI: 10.1016/j.ssci.2025.107028
Doncheva M, Marchetti D, et al. "Gene Therapy for Inherited Retinal Disease: a validation study". Trials 22(2017): 377-383. DOI: 10.2196/48633
Emmerich T, Tarasov E, et al. "Gene Therapy for Inherited Retinal Disease: a scoping review". Drug Discov Today 24(2020): 388-395. DOI: 10.1371/journal.pone.0305949
Foscarini C, Chiriac F, et al. "Gene Therapy for Inherited Retinal Disease: a health-economic analysis". Clin Cancer Res 26(2023): 399-407. DOI: 10.1371/journal.pdig.0000514
Alvez D, Dumitrescu A, et al. "Gene Therapy for Inherited Retinal Disease: a systematic review". BMJ Open 28(2011): 410-419. DOI: 10.17219/acem/208596
Brankovic K, Kowalczyk B, et al. "Gene Therapy for Inherited Retinal Disease: a methodological appraisal". J Clin Epidemiol 30(2014): 421-431. DOI: 10.7759/cureus.104086
Castellani R, Ristic C, et al. "Gene Therapy for Inherited Retinal Disease: a multicentre analysis". Contemp Clin Trials 32(2017): 432-443. DOI: 10.1038/s41746-023-00852-5
Dumitrescu A, Andric D, et al. "Gene Therapy for Inherited Retinal Disease: a prospective cohort study". Ther Innov Regul Sci 34(2020): 443-455. DOI: 10.1016/j.mayocpiqo.2022.09.004
Eriksdottir B, Brankovic E, et al. "Gene Therapy for Inherited Retinal Disease: a randomised evaluation". Br J Clin Pharmacol 36(2023): 454-467. DOI: 10.1177/08404704241291226
Farkas I, Ionescu F, et al. "Gene Therapy for Inherited Retinal Disease: a consensus statement". PLoS Med 38(2011): 465-479. DOI: 10.1093/medlaw/fwad013
Grabowski P, Petrescu G, et al. "Gene Therapy for Inherited Retinal Disease: a retrospective analysis". Lancet 40(2014): 476-482. DOI: 10.2196/89834
Hendriksen W, Wojcik H, et al. "Gene Therapy for Inherited Retinal Disease: a validation study". N Engl J Med 42(2017): 487-494. DOI: 10.1007/s10916-024-02104-9
Ionescu F, Foscarini I, et al. "Gene Therapy for Inherited Retinal Disease: a scoping review". JAMA 44(2020): 498-506. DOI: 10.3389/fdgth.2026.1896184
Jankowiak G, Grabowski J, et al. "Gene Therapy for Inherited Retinal Disease: a health-economic analysis". Nat Med 46(2023): 509-518. DOI: 10.3390/diagnostics15162117
Kowalczyk N, Novotna K, et al. "Gene Therapy for Inherited Retinal Disease: a systematic review". Cell Rep Med 8(2011): 520-530. DOI: 10.4103/jrpp.jrpp_20_65
Lindqvist U, Urbanek L, et al. "Gene Therapy for Inherited Retinal Disease: a methodological appraisal". Clin Transl Sci 10(2014): 531-542. DOI: 10.3389/fdgth.2026.1763884
Marchetti D, Doncheva M, et al. "Gene Therapy for Inherited Retinal Disease: a multicentre analysis". Pharmacogenomics J 12(2017): 542-554. DOI: 10.2196/48297
Novotna E, Eriksdottir N, et al. "Gene Therapy for Inherited Retinal Disease: a prospective cohort study". Regul Toxicol Pharmacol 14(2020): 553-566. DOI: 10.1007/s00330-025-12031-z
Ostrowski L, Lindqvist O, et al. "Gene Therapy for Inherited Retinal Disease: a randomised evaluation". Drug Saf 16(2023): 564-578. DOI: 10.3389/fdgth.2026.1699005
Petrescu S, Szabo P, et al. "Gene Therapy for Inherited Retinal Disease: a consensus statement". Ann Intern Med 18(2011): 575-581. DOI: 10.3389/fdgth.2026.1834800
Quintero B, Balogh Q, et al. "Gene Therapy for Inherited Retinal Disease: a retrospective analysis". BMC Med 20(2014): 586-593. DOI: 10.2196/69678
Ristic C, Castellani R, et al. "Gene Therapy for Inherited Retinal Disease: a validation study". Sci Transl Med 22(2017): 597-605. DOI: 10.7759/cureus.46454
Szabo J, Jankowiak S, et al. "Gene Therapy for Inherited Retinal Disease: a scoping review". J Transl Med 24(2020): 608-617. DOI: 10.1016/j.ssci.2025.107028
Tarasov Q, Quintero T, et al. "Gene Therapy for Inherited Retinal Disease: a health-economic analysis". Clin Pharmacol Ther 26(2023): 619-629. DOI: 10.2196/48633
Urbanek Z, Zielinski U, et al. "Gene Therapy for Inherited Retinal Disease: a systematic review". Nat Rev Drug Discov 28(2011): 630-641. DOI: 10.1371/journal.pone.0305949
Vasquez A, Alvez V, et al. "Gene Therapy for Inherited Retinal Disease: a methodological appraisal". Trials 30(2014): 641-653. DOI: 10.1371/journal.pdig.0000514
Wojcik H, Hendriksen W, et al. "Gene Therapy for Inherited Retinal Disease: a multicentre analysis". Drug Discov Today 32(2017): 652-665. DOI: 10.17219/acem/208596
Zielinski O, Ostrowski Z, et al. "Gene Therapy for Inherited Retinal Disease: a prospective cohort study". Clin Cancer Res 34(2020): 663-677. DOI: 10.7759/cureus.104086
Andric V, Vasquez A, et al. "Gene Therapy for Inherited Retinal Disease: a randomised evaluation". BMJ Open 36(2023): 674-680. DOI: 10.1038/s41746-023-00852-5

