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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.
b035660d-4501-4592-bdd8-aedaa7ecfbe7
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.
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George, S.
b035660d-4501-4592-bdd8-aedaa7ecfbe7
Lotery, A.J.
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Majid, M.
32c8309d-27cd-4e5e-966c-e5814f07068d
McKibbin, M.
65e194c2-62e4-4a79-b442-ef92de81e625
Menon, G.
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Yang, Y.
0c661323-7e23-41c6-a9a2-b4479fd74ef1
Andrews, C.
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Brittain, C.
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Osborne, A.
b10bb714-d815-4242-98fe-eeae8d99a990

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: 15 Mar 2024 03:16

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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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