September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Two- year results of a randomized prospective sham-controlled study comparing proton beam irradiation combined with ranibizumab with ranibizumab monotherapy for exudative age-related macular degeneration
Author Affiliations & Notes
  • Senad Osmanovic
    Ophthalmology, University of California Davis, SACRAMENTO, California, United States
  • Elad Moisseiev
    Ophthalmology, University of California Davis, SACRAMENTO, California, United States
  • Kavita Mishra
    Radiation Oncology, University of California San Francisco, San Francisco, California, United States
  • Inder Daftari
    Radiation Oncology, University of California San Francisco, San Francisco, California, United States
  • Lawrence S Morse
    Ophthalmology, University of California Davis, SACRAMENTO, California, United States
  • Ala Moshiri
    Ophthalmology, University of California Davis, SACRAMENTO, California, United States
  • Susanna S Park
    Ophthalmology, University of California Davis, SACRAMENTO, California, United States
  • Footnotes
    Commercial Relationships   Senad Osmanovic, None; Elad Moisseiev, None; Kavita Mishra, None; Inder Daftari, None; Lawrence Morse, None; Ala Moshiri, None; Susanna Park, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 4427. doi:
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      Senad Osmanovic, Elad Moisseiev, Kavita Mishra, Inder Daftari, Lawrence S Morse, Ala Moshiri, Susanna S Park; Two- year results of a randomized prospective sham-controlled study comparing proton beam irradiation combined with ranibizumab with ranibizumab monotherapy for exudative age-related macular degeneration. Invest. Ophthalmol. Vis. Sci. 2016;57(12):4427.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Exudative AMD (eAMD) remains a leading cause of severe visual loss in the developed world, and the need for new treatment strategies remains strong. We seek to evaluate the efficacy and safety of combination low-dose proton beam therapy (PBT) with anti-VEGF versus anti-VEGF monotherapy in exudative AMD, and provide here an interim 2 year analysis of a prospective randomized control trial.

Methods : 30 Eyes with nvAMD (classic and occult lesions) were randomized to either sham irradiation or to either 16 or 24Gy PBT, given in 2 fractions 24 hours apart. Patients underwent monthly examinations with ranibizumab administered prn. Main outcome measures were change in BCVA, mean number of injections, severe visual loss (> 15 letters) and development of radiation retinopathy or neuropathy at 24 months. Changes in the morphologic features of neovascular lesions and macular fluid on OCT, fundus and angiography imaging over were also assessed.

Results : Groups were evenly distributed among 3 study groups at baseline with no differences in baseline BCVA, lesion size or demographic profile. Average patient age was 77.7 (SD 7.4) with baseline visual acuity of 0.61 logMAR (±0.29). Among 18 eyes completing 24 month follow-up (sham n=5, 16Gy n=6, 24Gy n=7), BCVA remained stable in all 3 groups during the second year of study, without significant difference among groups. Mean BCVA at 2 years was 0.59 logMAR ±0.33. The mean number of injections was statistically lower in both the 16Gy (n=7.4) the 24Gy group (n=5.4) when compared to sham treatment group (n=11), p= 0.023, p=0.001 respectively. OCT analysis showed a trend towards more reduction in central macular thickness at 2 years with radiation and anti-VEGF combined treatment (both 16Gy and 24Gy) when compared to anti-VEGF monotherapy. There was no case of severe visual loss. There were 2 cases of suspected visually insignificant radiation retinopathy, one for each of the radiation dose subgroups.

Conclusions : Interim analysis at 2-years show no significant safety concerns combining proton beam irradiation with anti-VEGF therapy for eAMD. A synergistic effect resulting in less need for re-injection with anti-VEGF was noted using 16 or 24Gy proton. The complete 2 year follow-up data will be presented to determine whether these interim findings are sustained.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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