Artikel
CNV secondary to AMD treated with Beta Radiation Epiretinal Therapy to reduce the number of ranibizumab treatments (CABERNET-Trial)
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Veröffentlicht: | 18. Juni 2008 |
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Aim: The objective of the CABERNET-Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) in age-related macular degeneration (AMD).
Methods: A randomized, prospective, active controlled study that compares a single surgical procedure using the Epi-Rad90™ Ophthalmic System within a standard vitrectomy plus 2 injections of ranibizumab administered 1 month apart (Group A) with ranibizumab injections administered monthly for the first 3 injections followed by quarterly injections (Group B) in a non inferiority design in 20 US centers and 10 centers outside the US (2 in Germany). Using standard vitreoretinal surgical techniques, the sealed strontium radiation source is placed temporarily over the retinal lesion by means of a handheld medical device. The foveal dose is 24Gy. The primary endpoint is the percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baselineIncluded are subjects with any CNV secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of < 12 total disc areas, and a max. GLD of 5.4 mm.
Results: The results of a preceding phase 2 study (with bevacizumab) were encouraging. Only 5/35 Patients needed more than two injections. Mean visual acuity rose from baseline by 13 letters and remained stable over this time. 48% of patients doubled their baseline visual acuity at one year of follow up.
Conclusion: intravitreal radiation may reduce the total number of ranibizumab injections with a comparable functional outcome.