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Stereotactic radiotherapy for neovascular age-related macular degeneration: 52-week safety and efficacy results of the INTREPID study.
Ophthalmology 2013; 120(9):1893-900O

Abstract

PURPOSE

To determine the safety and efficacy of low-voltage, external-beam, stereotactic radiotherapy (SRT) for patients with neovascular age-related macular degeneration (nvAMD).

DESIGN

Randomized, double-masked, sham-controlled, multicenter, clinical trial.

PARTICIPANTS

Two hundred thirty patients with onset of nvAMD within 3 years who received 3 or more injections of ranibizumab or bevacizumab within the preceding year and who needed continuing ranibizumab or bevacizumab treatment.

INTERVENTIONS

Participants were randomized 2:1:2:1 to 16 Gy plus pro re nata (PRN) ranibizumab, sham 16 Gy plus PRN ranibizumab, 24 Gy plus PRN ranibizumab, or sham 24 Gy plus PRN ranibizumab, respectively.

MAIN OUTCOME MEASURES

The primary efficacy end point was the mean number of ranibizumab injections at 52 weeks. Secondary end points were change in mean best-corrected visual acuity (VA), loss of fewer than 15 Early Treatment Diabetic Retinopathy Study letters, gain of 0 or more and 15 or more letters, and change in angiographic total lesion size and choroidal neovascularization (CNV) lesion size.

RESULTS

Both the 16-Gy and 24-Gy SRT arms received significantly fewer ranibizumab treatments compared with the sham arms: mean number of treatments, 2.64 (median, 2), 2.43 (median, 2), and 3.74 (median, 3.5), respectively (P = 0.013 and P = 0.004, respectively, vs. sham). Change in mean VA was -0.28, +0.40, and -1.57 letters for the 16-Gy, 24-Gy, and sham arms, respectively. The 16-Gy, 24-Gy, and sham arms lost fewer than 15 letters in 93%, 89%, and 91% of eyes, respectively, with 53%, 57%, and 56% gaining 0 or more letters, respectively, and 4% gaining 15 letters or more in all arms. Mean total angiographic lesion area changed by -1.15 mm(2), +0.49 mm(2), and +0.75 mm(2), respectively; mean CNV lesion area decreased by 0.16 mm(2), 0.18 mm(2), and 0.10 mm(2), respectively. Optical coherence tomography central subfield thickness decreased by 85.90 μm, 70.39 μm, and 33.51 μm, respectively. The number of adverse events (AEs) and number of serious AEs (SAEs) were similar across arms. No AEs were attributed to radiation. No SAEs occurred in the study eye.

CONCLUSIONS

A single dose of SRT significantly reduces ranibizumab retreatment for patients with nvAMD, with a favorable safety profile at 1 year. Whereas chronic nvAMD typically results in loss of VA over time, SRT is associated with relatively well-preserved VA over 1 year.

FINANCIAL DISCLOSURE(S)

Proprietary or commercial disclosure may be found after the references.

Authors+Show Affiliations

King's College London, London, United Kingdom.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

23490327

Citation

Jackson, Timothy L., et al. "Stereotactic Radiotherapy for Neovascular Age-related Macular Degeneration: 52-week Safety and Efficacy Results of the INTREPID Study." Ophthalmology, vol. 120, no. 9, 2013, pp. 1893-900.
Jackson TL, Chakravarthy U, Kaiser PK, et al. Stereotactic radiotherapy for neovascular age-related macular degeneration: 52-week safety and efficacy results of the INTREPID study. Ophthalmology. 2013;120(9):1893-900.
Jackson, T. L., Chakravarthy, U., Kaiser, P. K., Slakter, J. S., Jan, E., Bandello, F., ... Moshfeghi, D. M. (2013). Stereotactic radiotherapy for neovascular age-related macular degeneration: 52-week safety and efficacy results of the INTREPID study. Ophthalmology, 120(9), pp. 1893-900. doi:10.1016/j.ophtha.2013.02.016.
Jackson TL, et al. Stereotactic Radiotherapy for Neovascular Age-related Macular Degeneration: 52-week Safety and Efficacy Results of the INTREPID Study. Ophthalmology. 2013;120(9):1893-900. PubMed PMID: 23490327.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stereotactic radiotherapy for neovascular age-related macular degeneration: 52-week safety and efficacy results of the INTREPID study. AU - Jackson,Timothy L, AU - Chakravarthy,Usha, AU - Kaiser,Peter K, AU - Slakter,Jason S, AU - Jan,Ernest, AU - Bandello,Francesco, AU - O'Shaughnessy,Denis, AU - Gertner,Michael E, AU - Danielson,Linda, AU - Moshfeghi,Darius M, AU - ,, Y1 - 2013/03/13/ PY - 2012/09/20/received PY - 2013/02/13/revised PY - 2013/02/13/accepted PY - 2013/3/16/entrez PY - 2013/3/16/pubmed PY - 2013/11/20/medline SP - 1893 EP - 900 JF - Ophthalmology JO - Ophthalmology VL - 120 IS - 9 N2 - PURPOSE: To determine the safety and efficacy of low-voltage, external-beam, stereotactic radiotherapy (SRT) for patients with neovascular age-related macular degeneration (nvAMD). DESIGN: Randomized, double-masked, sham-controlled, multicenter, clinical trial. PARTICIPANTS: Two hundred thirty patients with onset of nvAMD within 3 years who received 3 or more injections of ranibizumab or bevacizumab within the preceding year and who needed continuing ranibizumab or bevacizumab treatment. INTERVENTIONS: Participants were randomized 2:1:2:1 to 16 Gy plus pro re nata (PRN) ranibizumab, sham 16 Gy plus PRN ranibizumab, 24 Gy plus PRN ranibizumab, or sham 24 Gy plus PRN ranibizumab, respectively. MAIN OUTCOME MEASURES: The primary efficacy end point was the mean number of ranibizumab injections at 52 weeks. Secondary end points were change in mean best-corrected visual acuity (VA), loss of fewer than 15 Early Treatment Diabetic Retinopathy Study letters, gain of 0 or more and 15 or more letters, and change in angiographic total lesion size and choroidal neovascularization (CNV) lesion size. RESULTS: Both the 16-Gy and 24-Gy SRT arms received significantly fewer ranibizumab treatments compared with the sham arms: mean number of treatments, 2.64 (median, 2), 2.43 (median, 2), and 3.74 (median, 3.5), respectively (P = 0.013 and P = 0.004, respectively, vs. sham). Change in mean VA was -0.28, +0.40, and -1.57 letters for the 16-Gy, 24-Gy, and sham arms, respectively. The 16-Gy, 24-Gy, and sham arms lost fewer than 15 letters in 93%, 89%, and 91% of eyes, respectively, with 53%, 57%, and 56% gaining 0 or more letters, respectively, and 4% gaining 15 letters or more in all arms. Mean total angiographic lesion area changed by -1.15 mm(2), +0.49 mm(2), and +0.75 mm(2), respectively; mean CNV lesion area decreased by 0.16 mm(2), 0.18 mm(2), and 0.10 mm(2), respectively. Optical coherence tomography central subfield thickness decreased by 85.90 μm, 70.39 μm, and 33.51 μm, respectively. The number of adverse events (AEs) and number of serious AEs (SAEs) were similar across arms. No AEs were attributed to radiation. No SAEs occurred in the study eye. CONCLUSIONS: A single dose of SRT significantly reduces ranibizumab retreatment for patients with nvAMD, with a favorable safety profile at 1 year. Whereas chronic nvAMD typically results in loss of VA over time, SRT is associated with relatively well-preserved VA over 1 year. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/23490327/Stereotactic_radiotherapy_for_neovascular_age_related_macular_degeneration:_52_week_safety_and_efficacy_results_of_the_INTREPID_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(13)00150-4 DB - PRIME DP - Unbound Medicine ER -