Phase IIb clinical trial of ranibizumab for the treatment of uveitic and idiopathic choroidal neovascular membranes

Ester Carreño; Tanya Moutray; Konstantinos Fotis; Richard W J Lee; Andrew D Dick; Adam H Ross; Clare Bailey

doi:10.1136/bjophthalmol-2015-307806

Phase IIb clinical trial of ranibizumab for the treatment of uveitic and idiopathic choroidal neovascular membranes

Ester Carreño, Tanya Moutray, Konstantinos Fotis, Richard W J Lee, Andrew D Dick, Adam H Ross, Clare Bailey

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Abstract

AIM: To assess the efficacy of intravitreal ranibizumab for the treatment of new onset inflammatory choroidal neovascularisation (iCNV), including both uveitic and idiopathic CNVs.

METHODS: Single-centre, open-label, non-randomised Phase IIb clinical trial. Patients fulfilling strict entry criteria of new onset iCNV were given monthly intravitreal ranibizumab injections for 3 months. Thereafter, re-treatment was based on evidence of persisting activity. All patients completed trial follow-up. Optical coherence tomography (OCT) and best-corrected visual acuity (BCVA) were performed at every visit. Fluorescein angiography was performed at baseline, months 4 and 12. Descriptive analysis and Wilcoxon non-parametric test were performed for analysis.

RESULTS: 15 patients, 10 women with a mean age of 48.8 years (range 24-85 years) were included in the study. The mean number of injections was 4.33 (range 3-7). There was a statistically significant difference in the BCVA at month 4 (p=0.001) and at month 12 (p=0.001) compared with baseline. The mean gain in BCVA at month 4 compared with baseline was 20±15.36 letters (mean±SD), and at month 12 was 21±16.97 letters. There was a statistically significant difference in the mean central subfield thickness (CST) at baseline versus month 4 (p=0.003) and month 12 (p=0.001).

CONCLUSION: Patients gained vision (mean of 21 letters at 12 months) and showed reduced CST. These results support the continued use of ranibizumab in the treatment of iCNV.

TRIAL REGISTRATION NUMBER: 2008-007476-19, results.

Original language	English
Pages (from-to)	1221-1226
Number of pages	6
Journal	British Journal of Ophthalmology
Volume	100
Issue number	9
Early online date	16 Dec 2015
DOIs	https://doi.org/10.1136/bjophthalmol-2015-307806
Publication status	Published - Sept 2016

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title = "Phase IIb clinical trial of ranibizumab for the treatment of uveitic and idiopathic choroidal neovascular membranes",

abstract = "AIM: To assess the efficacy of intravitreal ranibizumab for the treatment of new onset inflammatory choroidal neovascularisation (iCNV), including both uveitic and idiopathic CNVs.METHODS: Single-centre, open-label, non-randomised Phase IIb clinical trial. Patients fulfilling strict entry criteria of new onset iCNV were given monthly intravitreal ranibizumab injections for 3 months. Thereafter, re-treatment was based on evidence of persisting activity. All patients completed trial follow-up. Optical coherence tomography (OCT) and best-corrected visual acuity (BCVA) were performed at every visit. Fluorescein angiography was performed at baseline, months 4 and 12. Descriptive analysis and Wilcoxon non-parametric test were performed for analysis.RESULTS: 15 patients, 10 women with a mean age of 48.8 years (range 24-85 years) were included in the study. The mean number of injections was 4.33 (range 3-7). There was a statistically significant difference in the BCVA at month 4 (p=0.001) and at month 12 (p=0.001) compared with baseline. The mean gain in BCVA at month 4 compared with baseline was 20±15.36 letters (mean±SD), and at month 12 was 21±16.97 letters. There was a statistically significant difference in the mean central subfield thickness (CST) at baseline versus month 4 (p=0.003) and month 12 (p=0.001).CONCLUSION: Patients gained vision (mean of 21 letters at 12 months) and showed reduced CST. These results support the continued use of ranibizumab in the treatment of iCNV.TRIAL REGISTRATION NUMBER: 2008-007476-19, results.",

author = "Ester Carre{\~n}o and Tanya Moutray and Konstantinos Fotis and Lee, {Richard W J} and Dick, {Andrew D} and Ross, {Adam H} and Clare Bailey",

note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/",

year = "2016",

month = sep,

doi = "10.1136/bjophthalmol-2015-307806",

language = "English",

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T1 - Phase IIb clinical trial of ranibizumab for the treatment of uveitic and idiopathic choroidal neovascular membranes

AU - Carreño, Ester

AU - Moutray, Tanya

AU - Fotis, Konstantinos

AU - Lee, Richard W J

AU - Dick, Andrew D

AU - Ross, Adam H

AU - Bailey, Clare

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016/9

Y1 - 2016/9

N2 - AIM: To assess the efficacy of intravitreal ranibizumab for the treatment of new onset inflammatory choroidal neovascularisation (iCNV), including both uveitic and idiopathic CNVs.METHODS: Single-centre, open-label, non-randomised Phase IIb clinical trial. Patients fulfilling strict entry criteria of new onset iCNV were given monthly intravitreal ranibizumab injections for 3 months. Thereafter, re-treatment was based on evidence of persisting activity. All patients completed trial follow-up. Optical coherence tomography (OCT) and best-corrected visual acuity (BCVA) were performed at every visit. Fluorescein angiography was performed at baseline, months 4 and 12. Descriptive analysis and Wilcoxon non-parametric test were performed for analysis.RESULTS: 15 patients, 10 women with a mean age of 48.8 years (range 24-85 years) were included in the study. The mean number of injections was 4.33 (range 3-7). There was a statistically significant difference in the BCVA at month 4 (p=0.001) and at month 12 (p=0.001) compared with baseline. The mean gain in BCVA at month 4 compared with baseline was 20±15.36 letters (mean±SD), and at month 12 was 21±16.97 letters. There was a statistically significant difference in the mean central subfield thickness (CST) at baseline versus month 4 (p=0.003) and month 12 (p=0.001).CONCLUSION: Patients gained vision (mean of 21 letters at 12 months) and showed reduced CST. These results support the continued use of ranibizumab in the treatment of iCNV.TRIAL REGISTRATION NUMBER: 2008-007476-19, results.

AB - AIM: To assess the efficacy of intravitreal ranibizumab for the treatment of new onset inflammatory choroidal neovascularisation (iCNV), including both uveitic and idiopathic CNVs.METHODS: Single-centre, open-label, non-randomised Phase IIb clinical trial. Patients fulfilling strict entry criteria of new onset iCNV were given monthly intravitreal ranibizumab injections for 3 months. Thereafter, re-treatment was based on evidence of persisting activity. All patients completed trial follow-up. Optical coherence tomography (OCT) and best-corrected visual acuity (BCVA) were performed at every visit. Fluorescein angiography was performed at baseline, months 4 and 12. Descriptive analysis and Wilcoxon non-parametric test were performed for analysis.RESULTS: 15 patients, 10 women with a mean age of 48.8 years (range 24-85 years) were included in the study. The mean number of injections was 4.33 (range 3-7). There was a statistically significant difference in the BCVA at month 4 (p=0.001) and at month 12 (p=0.001) compared with baseline. The mean gain in BCVA at month 4 compared with baseline was 20±15.36 letters (mean±SD), and at month 12 was 21±16.97 letters. There was a statistically significant difference in the mean central subfield thickness (CST) at baseline versus month 4 (p=0.003) and month 12 (p=0.001).CONCLUSION: Patients gained vision (mean of 21 letters at 12 months) and showed reduced CST. These results support the continued use of ranibizumab in the treatment of iCNV.TRIAL REGISTRATION NUMBER: 2008-007476-19, results.

U2 - 10.1136/bjophthalmol-2015-307806

DO - 10.1136/bjophthalmol-2015-307806

M3 - Article (Academic Journal)

C2 - 26674776

SN - 0007-1161

VL - 100

SP - 1221

EP - 1226

JO - British Journal of Ophthalmology

JF - British Journal of Ophthalmology

IS - 9

ER -

Phase IIb clinical trial of ranibizumab for the treatment of uveitic and idiopathic choroidal neovascular membranes

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