16 and 24 Gy low-voltage X-ray irradiation with ranibizumab therapy for neovascular age-related macular degeneration: 12-month outcomes.

Abstract

PURPOSE:

To describe the 12-month safety and efficacy outcomes of 16 or 24 Gy radiation using low-voltage x-ray irradiation in conjunction with intravitreal ranibizumab for neovascular age-related macular degeneration (AMD).

DESIGN:

Prospective, phase I, open-label, nonrandomized uncontrolled safety study.

METHODS:

setting: Institutional. study population: Neovascular AMD patients. intervention: One x-ray irradiation treatment at 16 or 24 Gy was administered externally through 3 locations in the inferior pars plana. After 2 initial monthly loading doses of ranibizumab, subsequent ranibizumab was administered according to predetermined criteria. main outcome measures: Visual acuity, number of ranibizumab injections, safety and efficacy metrics at 12 months.

RESULTS:

Forty-seven eyes of 47 patients were enrolled and completed 12 months of follow-up: 16 Gy (n = 28) and 24 Gy (n = 19). There was no evidence of radiation retinopathy, optic neuropathy, or cataract. The mean visual acuity improved in both groups: +8.4 ± 11.9 letters and +7.8 ± 12 letters for 16 and 24 Gy, respectively. In both groups, 100% of subjects lost <15 letters, with 76% and 79% gaining ≥0 letters in the 16 Gy and 24 Gy groups, respectively. Patients received a mean of 1.0 additional injection over 12 months. The mean change in optical coherence tomography central subfield thickness from baseline to month 12 was -107 and -87 μm for the 16 Gy and 24 Gy groups, respectively.

CONCLUSION:

One treatment of 16 or 24 Gy low-voltage x-ray therapy with as-needed ranibizumab appears safe in subjects with neovascular AMD at 12 months. An overall improvement in visual acuity was observed. No radiation-related adverse effects were reported.

• Authors: Virgilio Morales-Canton, Hugo Quiroz-Mercado, Raul Velez-Montoya, Alicia Zavala-Ayala, Andrew A Moshfeghi, E Mark Shusterman, Peter K Kaiser, Steven R Sanislo, Michael Gertner, Darius M Moshfeghi
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 155 Issue 6 Pg. 1000-1008.e2 (Jun 2013) ISSN: 1879-1891 [Electronic] United States
• PMID: 23497847 (Publication Type: Clinical Trial, Phase I, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Antibodies, Monoclonal, Humanized
• Ranibizumab

Topics

• Angiogenesis Inhibitors (therapeutic use)
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Combined Modality Therapy
• Female
• Fluorescein Angiography
• Humans
• Intravitreal Injections
• Male
• Middle Aged
• Prospective Studies
• Radiotherapy Dosage
• Ranibizumab
• Retreatment
• Tomography, Optical Coherence
• Treatment Outcome
• Visual Acuity (physiology)
• Wet Macular Degeneration (drug therapy, physiopathology, radiotherapy)