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ABSTRACT: PURPOSE:: To determine if epimacular brachytherapy is associated with reduced retinal sensitivity or choroidal nonperfusion. METHODS:: A prospective intervention case series of 12 participants with neovascular age-related macular degeneration requiring frequent ranibizumab underwent vitrectomy and epimacular brachytherapy. The Strontium 90/Yttrium 90 source delivered a single 24-Gy dose at the center of the treatment zone. The dose attenuated with increasing distance from the source. Microperimetry and indocyanine green angiography were performed at baseline and 12 months. The main outcome measures were mean sensitivity and choroidal nonperfusion. A linear mixed model was used to assess the association between the dose of radiation and the change in mean sensitivity. RESULTS:: Mean visual acuity remained within 1 letter of baseline at 12 months (-0.33 ± 13.2 letters). There was no statistically significant change in mean sensitivity within the neovascular age-related macular degeneration lesion area (gain of 0.94 ± 3.25 dB; P = 0.339) or in neighboring unaffected retina (0.66 ± 4.14 dB; P = 0.594), defined using fluorescein angiography. Within the lesion area, mean sensitivity improved by an average of 0.23 ± 0.16 dB (P = 0.006) for every additional gray of radiation received. Indocyanine green angiography failed to demonstrate any choroidal nonperfusion or radiation damage at 12 months after the treatment. CONCLUSION:: Stable retinal sensitivity in areas not manifestly affected by neovascular age-related macular degeneration suggests that epimacular brachytherapy does not damage retinal function. The presence of a dose response suggests that the positive effect of epimacular brachytherapy relates more to beta irradiation than vitrectomy.
Retina (Philadelphia, Pa.) 03/2013; · 2.93 Impact Factor
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ABSTRACT: PURPOSE: To report the optical coherence tomography (OCT) and fundus fluorescein angiography (FFA) results of the Macular Epiretinal Brachytherapy in Treated Age-Related Macular Degeneration study. DESIGN: Prospective, multicenter, interventional, noncontrolled clinical trial. PARTICIPANTS: Fifty-three eyes of 53 participants with chronic, active neovascular age-related macular degeneration (AMD) requiring frequent anti-vascular endothelial growth factor retreatment. METHODS: Participants underwent pars plana vitrectomy with a single 24-gray dose of epimacular brachytherapy (EMB), delivered with an intraocular, handheld, cannula containing a strontium 90/yttrium 90 source positioned over the active lesion. Participants were retreated with ranibizumab administered monthly as needed, using predefined retreatment criteria. Patients underwent FFA at baseline, month 1, and month 12. Patients underwent optical coherence tomography (OCT) at baseline and then monthly for 12 months. The FFA and OCT images were evaluated by independent, central reading facilities. MAIN OUTCOME MEASURES: Change in OCT centerpoint thickness and angiographic lesion size 12 months after EMB. RESULTS: Mean centerpoint thickness increased by 50 μm, from 186 to 236 μm (P = 0.292), but 70% of participants had an increase of less than the mean, with a median increase of only 1.8 μm. The FFA total lesion size increased slightly by 0.79 mm(2), from 14.69 to 15.48 mm(2) (P = 0.710). Total choroidal neovascularization (CNV) area increased by 1.17 mm(2), from 12.94 to 14.12 mm(2) (P = 0.556). The classic CNV area decreased substantially by 3.70 mm(2), from 3.90 to 0.20 mm(2) (P<0.01). Predominantly classic lesions showed the greatest response, with mean Early Treatment Diabetic Retinopathy Study visual acuity improving by 1.5 letters (versus -4.0 for all participants combined); mean centerpoint thickness decreased by 43 μm (P = 0.875). The angiographic and OCT response did not correlate with lesion size at baseline. CONCLUSIONS: In chronic, active, neovascular AMD, EMB is associated with nonsignificant changes in centerpoint thickness and FFA total lesion size over 12 months. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
Ophthalmology 11/2012; · 5.45 Impact Factor
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ABSTRACT: PURPOSE: To evaluate the safety and efficacy of epimacular brachytherapy (EMBT) for the treatment of neovascular age-related macular degeneration (AMD). DESIGN: Multicenter, randomized, active-controlled, phase III clinical trial. PARTICIPANTS: Four hundred ninety-four participants with treatment-naïve neovascular AMD. METHODS: Participants with classic, minimally classic, and occult lesions were randomized in a 2:1 ratio to EMBT or a ranibizumab monotherapy control arm. The EMBT arm received 2 mandated, monthly loading injections of 0.5 mg ranibizumab. The control arm received 3 mandated, monthly loading injections of ranibizumab then quarterly injections. Both arms also received monthly as needed (pro re nata) retreatment. MAIN OUTCOME MEASURES: The proportion of participants losing fewer than 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline visual acuity (VA) and the proportion gaining more than 15 ETDRS letters from baseline VA. RESULTS: At 24 months, 77% of the EMBT group and 90% of the control group lost fewer than 15 letters. This difference did not meet the prespecified 10% noninferiority margin. This end point was noninferior using a 20% margin and a 95% confidence interval for the group as a whole and for classic and minimally classic lesions, but not for occult lesions. The EMBT did not meet the superiority end point for the proportion of participants gaining more than 15 letters (16% for the EMBT group vs. 26% for the control group): this difference was statistically significant (favoring controls) for occult lesions, but not for predominantly classic and minimally classic lesions. Mean VA change was -2.5 letters in the EMBT arm and +4.4 letters in the control arm. Participants in the EMBT arm received a mean of 6.2 ranibizumab injections versus 10.4 in the control arm. At least 1 serious adverse event occurred in 54% of the EMBT arm, most commonly postvitrectomy cataract, versus 18% in the control arm. Mild, nonproliferative radiation retinopathy occurred in 3% of the EMBT participants, but no case was vision threatening. CONCLUSIONS: The 2-year efficacy data do not support the routine use of EMBT for treatment-naïve wet AMD, despite an acceptable safety profile. Further safety review is required. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
Ophthalmology 11/2012; · 5.45 Impact Factor
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ABSTRACT: To evaluate the safety and efficacy of epimacular brachytherapy (EMB) for the treatment of chronic, active, neovascular age-related macular degeneration (AMD).
Prospective, multicenter, interventional, noncontrolled clinical trial.
Fifty-three eyes of 53 participants with neovascular AMD requiring frequent anti-vascular endothelial growth factor (VEGF) retreatment.
Participants underwent pars plana vitrectomy with a single 24-Gy dose of EMB delivered using an intraocular, handheld cannula containing a strontium 90/yttrium 90 source positioned over the active lesion. Participants were retreated with ranibizumab administered monthly as needed, using predefined retreatment criteria. Optical coherence tomography (OCT) was undertaken monthly, with images assessed by an independent reading center.
Coprimary outcomes at 12 months were proportion of participants with stable vision (losing <15 Early Treatment Diabetic Retinopathy Study [ETDRS] letters) and mean number of anti-VEGF retreatments.
Before enrollment, participants had received an average of 12.5 anti-VEGF injections. After a single treatment with EMB, 81% maintained stable vision, with a mean of 3.49 anti-VEGF retreatments in 12 months. Mean ± standard deviation change in visual acuity was -4.0±15.1 ETDRS letters. Mean ± standard deviation OCT central retinal thickness increased by 50±179 μm. Common adverse events included conjunctival hemorrhage (n = 38), cataract (n = 16), resolving vitreous hemorrhage (n = 6), and eye pain (n = 5).
Epimacular brachytherapy produces stable visual acuity in most participants with previously treated, active disease. Epimacular brachytherapy may reduce the need for frequent anti-VEGF retreatment.
Ophthalmology 03/2012; 119(7):1425-31. · 5.45 Impact Factor
