A prospective, randomized, double-masked trial on radiation therapy for neovascular age-related macular degeneration (RAD study)
Objective - To determine the efficacy of external beam radiation therapy on choroidal neovascularization (CNV) secondary to age-related macular degeneration (ARMD). - Design - Multicenter, parallel, randomized, double-masked clinical trial performed at nine ophthalmic and radiotherapeutic centers. -...
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| Main Authors: | , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
1999
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| In: |
Ophthalmology
Year: 1999, Volume: 106, Issue: 12, Pages: 2239-2247 |
| ISSN: | 1549-4713 |
| DOI: | 10.1016/S0161-6420(99)90522-5 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/S0161-6420(99)90522-5 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0161642099905225 
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| Author Notes: | The Radiation Therapy for Age-related Macular Degeneration (RAD) Study Group: [Hans Eberhard Völcker, F.G. Holz, R. Engenhart-Cabillic, K. Unnebrink, C. Bellmann, J. Debus, M. Pritsch, M. Wannenmacher] |
| Summary: | Objective - To determine the efficacy of external beam radiation therapy on choroidal neovascularization (CNV) secondary to age-related macular degeneration (ARMD). - Design - Multicenter, parallel, randomized, double-masked clinical trial performed at nine ophthalmic and radiotherapeutic centers. - Participants - Two hundred five patients were randomly assigned either to treatment with 8 fractions of 2 Gy external beam irradiation (n = 101) or to control with 8 fractions of 0 Gy (sham treatment, n = 104). Both patients and ophthalmologists were masked with regard to applied treatment. Patients with subfoveal classic or occult CNV, visual acuity of 20/320 or greater on the Early Treatment Diabetic Retinopathy Study chart, lesion size of 6 disc areas or less, history of visual symptoms of 6 months or less, and absence of foveal hemorrhage were recruited. - Intervention - In the treatment group, external beam irradiation with 8 fractions of 2 Gy was performed, whereas in the control group, sham treatment with 8 fractions of 0 Gy was applied. - Main outcome measures - Primary outcome measure was the difference in visual acuity between baseline and after 1 year of follow-up. - Results - One hundred eighty-three patients (89.3%) completed the 1-year follow-up. The mean reduction in visual acuity was 3.5 ± 4.7 lines in 88 patients of the 8- × 2-Gy treatment group and 3.7 ± 3.8 lines in 95 patients of the 8- × 0-Gy control group. This difference was not statistically significant (P = 0.53, Mann-Whitney U test). At 1 year, 51.1% of treated patients and 52.6% of control subjects lost three or more lines (P = 0.88). Visual acuity in the presence of classic CNV dropped by 3.7 ± 4.4 lines in 33 patients of the treatment group versus 4.3 ± 3.9 lines in 36 patients of the control group (P = 0.47). Visual acuity in 114 patients with occult CNV dropped by 3.4 ± 4.9 in the treatment group (55 patients) versus 3.4 ± 3.8 lines in the control group (59 patients) (P = 0.80). - Conclusions - In this randomized study, radiation therapy at a dose of 16 Gy applied in 8 fractions of 2 Gy provided no benefit as a treatment for subfoveal CNV secondary to ARMD at 1 year. |
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| Item Description: | Available online: 25 August 2003 Gesehen am 03.03.2021 |
| Physical Description: | Online Resource |
| ISSN: | 1549-4713 |
| DOI: | 10.1016/S0161-6420(99)90522-5 |