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Ranibizumab for the treatment of choroidal neovascularisation secondary to pathological myopia: interim analysis of the REPAIR study

Ranibizumab for the treatment of choroidal neovascularisation secondary to pathological myopia: interim analysis of the REPAIR study
Ranibizumab for the treatment of choroidal neovascularisation secondary to pathological myopia: interim analysis of the REPAIR study
AIMS: To evaluate the efficacy and safety of intravitreal ranibizumab in patients with choroidal neovascularisation secondary to pathological myopia (myopic CNV). Data are from a pre-planned, 6-month interim analysis.

METHODS: Phase II, open-label, single arm, multicentre, 12-month study, recruiting patients (aged ?18 years) with active primary or recurrent subfoveal or juxtafoveal myopic CNV, with a best-corrected visual acuity (BCVA) score of 24-78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye and a diagnosis of high myopia of at least -6 dioptres. Patients received 0.5 mg ranibizumab administered intravitreally to the study eye, followed by monthly injections given as needed (based on a predefined algorithm) for up to 11 months.

RESULTS: At 6 months, mean BCVA improved from baseline by 12.2 letters, as did central macular thickness (in this interim analysis defined as a measure of either central subfield macular thickness or centre point macular thickness) from baseline by 108 ?m in the 48 study eyes of 48 patients. Fewer patients had centre-involving intraretinal oedema (13.0% vs 91.5%), intraretinal cysts (10.9% vs 57.4%), or subretinal fluid (13.0% vs 66.0%) at 6 months than at baseline. Patients received a mean of 1.9 retreatments, were satisfied with ranibizumab treatment, and well being was maintained. No new safety signals were identified.

CONCLUSIONS: Results from the planned interim analysis support the role of ranibizumab in the treatment of myopic CNV, with excellent efficacy achieved with a low number of injections and few serious adverse events.
0950-222X
709-715
Tufail, A.
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Patel, P.J.
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Sivaprasad, S.
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Amoaku, W.
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Browning, A.C.
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Cole, M.
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Gale, R.
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George, S.
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Lotery, A.J.
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Majid, M.
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McKibbin, M.
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Menon, G.
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Yang, Y.
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Andrews, C.
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Brittain, C.
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Osborne, A.
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Tufail, A.
b55b3c74-e8b1-4f26-babd-3a3ba591e0d3
Patel, P.J.
e1301a3e-570d-4cdf-9419-2c7d38d48ece
Sivaprasad, S.
451d388e-50f3-4cfb-b963-e73461eed920
Amoaku, W.
0138eb63-d27c-4a56-b51a-bcab50efef06
Browning, A.C.
65dcce33-d5f5-4872-9f77-c0ac2ecfe266
Cole, M.
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Gale, R.
7e56d842-5237-4615-abef-477caee88ffc
George, S.
b035660d-4501-4592-bdd8-aedaa7ecfbe7
Lotery, A.J.
5ecc2d2d-d0b4-468f-ad2c-df7156f8e514
Majid, M.
32c8309d-27cd-4e5e-966c-e5814f07068d
McKibbin, M.
65e194c2-62e4-4a79-b442-ef92de81e625
Menon, G.
36fcc284-6e4e-4885-a6f2-c3c7af8c58cd
Yang, Y.
f2e3049f-3750-4497-ba13-7a9072f4b562
Andrews, C.
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Brittain, C.
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Osborne, A.
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Tufail, A., Patel, P.J., Sivaprasad, S., Amoaku, W., Browning, A.C., Cole, M., Gale, R., George, S., Lotery, A.J., Majid, M., McKibbin, M., Menon, G., Yang, Y., Andrews, C., Brittain, C. and Osborne, A. (2013) Ranibizumab for the treatment of choroidal neovascularisation secondary to pathological myopia: interim analysis of the REPAIR study. Eye, 27 (6), 709-715. (doi:10.1038/eye.2013.8). (PMID:23449508)

Record type: Article

Abstract

AIMS: To evaluate the efficacy and safety of intravitreal ranibizumab in patients with choroidal neovascularisation secondary to pathological myopia (myopic CNV). Data are from a pre-planned, 6-month interim analysis.

METHODS: Phase II, open-label, single arm, multicentre, 12-month study, recruiting patients (aged ?18 years) with active primary or recurrent subfoveal or juxtafoveal myopic CNV, with a best-corrected visual acuity (BCVA) score of 24-78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye and a diagnosis of high myopia of at least -6 dioptres. Patients received 0.5 mg ranibizumab administered intravitreally to the study eye, followed by monthly injections given as needed (based on a predefined algorithm) for up to 11 months.

RESULTS: At 6 months, mean BCVA improved from baseline by 12.2 letters, as did central macular thickness (in this interim analysis defined as a measure of either central subfield macular thickness or centre point macular thickness) from baseline by 108 ?m in the 48 study eyes of 48 patients. Fewer patients had centre-involving intraretinal oedema (13.0% vs 91.5%), intraretinal cysts (10.9% vs 57.4%), or subretinal fluid (13.0% vs 66.0%) at 6 months than at baseline. Patients received a mean of 1.9 retreatments, were satisfied with ranibizumab treatment, and well being was maintained. No new safety signals were identified.

CONCLUSIONS: Results from the planned interim analysis support the role of ranibizumab in the treatment of myopic CNV, with excellent efficacy achieved with a low number of injections and few serious adverse events.

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More information

Published date: 1 March 2013
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 359163
URI: http://eprints.soton.ac.uk/id/eprint/359163
ISSN: 0950-222X
PURE UUID: 7182eef0-4c70-408d-9ba1-47ef7689eb33
ORCID for A.J. Lotery: ORCID iD orcid.org/0000-0001-5541-4305

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Date deposited: 23 Oct 2013 12:32
Last modified: 12 Nov 2024 02:40

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Contributors

Author: A. Tufail
Author: P.J. Patel
Author: S. Sivaprasad
Author: W. Amoaku
Author: A.C. Browning
Author: M. Cole
Author: R. Gale
Author: S. George
Author: A.J. Lotery ORCID iD
Author: M. Majid
Author: M. McKibbin
Author: G. Menon
Author: Y. Yang
Author: C. Andrews
Author: C. Brittain
Author: A. Osborne

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