ArticleBMC ophthalmology2026
WT1-pulsed dendritic cell vaccination for neovascular age-related macular degeneration: a phase I pilot feasibility study.
Article in BMC ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundNeovascular age-related macular degeneration (nAMD) is a leading cause of vision loss. Although anti-VEGF therapy is effective, frequent injections carry risks and may not fully address the underlying disease process. Wilms' tumor gene 1 (WT1), an upstream regulator of VEGF, is expressed in choroidal neovascular membranes and may represent a biologically relevant adjunctive target in nAMD. This pilot study evaluated the safety, tolerability, and immunogenicity of WT1-targeted dendritic cell (WT1-DC) vaccines and their effects on retinal morphology and visual function in nAMD patients, with secondary endpoints including clinical outcomes and in vitro WT1-specific T-cell responses.
methodsTwo patients initially received three monthly intravitreal injections of aflibercept (2 mg each), followed by 15 subcutaneous vaccinations with WT1-DCs. The vaccine contained both WT1-specific helper and killer peptides restricted to HLA-A*24:02. In addition, a helper peptide restricted to MHC class II and class I (HLA-A*02:01/02:06) was used.
resultsWT1-DC vaccination was well tolerated, and adverse events were limited. One patient maintained a stable retinal morphology and visual acuity without additional anti-VEGF therapy, whereas the other experienced recurrent subretinal fluid accumulation requiring intermittent rescue injections and a gradual decline in best-corrected visual acuity. Peripheral blood mononuclear cells from both patients exhibited functional CD4 + and CD8 + T-cell responses during vaccination and produced IFN-γ and TNF-α upon WT1 peptide stimulation in vitro.
conclusionsWT1-DC vaccination was feasible and well tolerated in these two patients who were clinically managed within the nAMD spectrum. Exploratory laboratory findings suggested WT1 peptide-responsive T-cell activity in vitro, but clinically meaningful in vivo immunogenicity was not established. Given the extremely small sample size, the confounding effect of prior anti-VEGF loading therapy, and diagnostic uncertainty regarding CNV etiology in one patient, no conclusions regarding therapeutic efficacy can be drawn. These observations support further investigations of WT1-DC vaccination in larger controlled studies.
trial registrationJapan Registry of Clinical Trials (jRCTc030210068), registered May 7, 2021.
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