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Phase I/II randomized study of proton beam with anti-VEGF for exudative age-related macular degeneration: long-term results.
Mukkamala, Lekha K; Mishra, Kavita; Daftari, Inder; Moshiri, Ala; Park, Susanna S.
Afiliación
  • Mukkamala LK; Vitreoretinal Service, Department of Ophthalmology & Vision Science, University of California Davis Eye Center, Sacramento, CA, USA.
  • Mishra K; Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA.
  • Daftari I; Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA.
  • Moshiri A; Vitreoretinal Service, Department of Ophthalmology & Vision Science, University of California Davis Eye Center, Sacramento, CA, USA.
  • Park SS; Vitreoretinal Service, Department of Ophthalmology & Vision Science, University of California Davis Eye Center, Sacramento, CA, USA. sscpark@ucdavis.edu.
Eye (Lond) ; 34(12): 2271-2279, 2020 12.
Article en En | MEDLINE | ID: mdl-32055016
BACKGROUND/OBJECTIVE: To determine if treatment of exudative age-related macular degeneration (eAMD) using proton beam therapy (PBT) combined with intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy is safe and effective long term. SUBJECT/METHODS: Thirty eyes with newly diagnosed eAMD were enrolled in a phase I/II prospective, sham-controlled double-masked university study. Eyes were randomized 1:1:1-24 GyE, 16 GyE or sham radiation, and treated with three initial monthly intravitreal ranibizumab or bevacizumab. Subsequent anti-VEGF reinjection was based on monthly optical coherence tomography and examination for 2 years and standard of care thereafter. RESULTS: A total of 23 eyes completed 2-year study follow-up, of which 16 maintained monthly follow-up. Mean best-correct visual acuity (BCVA) at 2 years was similar among treatment groups (p > 0.05). The 24 GyE group required fewer anti-VEGF injections when compared with the sham group at 2 years (4.67 ± 1.9 vs 9.67 ± 3.5; p = 0.017). Extended follow-up (mean 4 years) available in 22 eyes showed persistent reduced need for anti-VEGF therapy among eyes treated with 24 GyE compared with sham radiation (2.0 ± 1.6 vs 4.84 ± 2.4 per year, p = 0.008). New and increasing geographic atrophy (GA), noted in some eyes in all treatment groups, resulted in decreased mean BCVA from baseline for the 24 GyE group on extended follow-up (p = 0.009). Possible mild radiation retinopathy noted in 15% of eyes was not visually significant. CONCLUSIONS: Initial treatment combining PBT (24 GyE) with intravitreal anti-VEGF therapy appears to decrease the need for anti-VEGF reinjection in eyes with newly diagnosed eAMD. Radiation retinopathy risk was low and does not appear visually significant. Long-term vision was limited by GA development especially in the 24 GyE group.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protones / Atrofia Geográfica Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Eye (Lond) Asunto de la revista: OFTALMOLOGIA Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protones / Atrofia Geográfica Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Eye (Lond) Asunto de la revista: OFTALMOLOGIA Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido