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Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants

Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants
Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants
Purpose: Diabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2??g/day FAc implant.

Methods: This analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration.

Results: Best corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ?3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline.

Conclusions: These data support the use of 0.2??g/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract.
0950-222X
1173-1180
Yang, Y.
0c661323-7e23-41c6-a9a2-b4479fd74ef1
Bailey, C.
e4c10869-bc21-42d7-b5fb-829bd810dbc2
Holz, F.G.
5900cb42-0be2-4362-89b0-98d8a9d0fe8e
Eter, N.
617b04ec-17cf-49df-99ec-b3b30814f9ff
Weber, M.
9d3b3715-fde2-4207-9315-f26ed61ddd71
Baker, C.
04dda9b5-d169-4c54-a963-d97eae49da33
Kiss, S.
dc2ac738-edd3-4c19-9ae7-f639d0205f08
Menchini, U.
7a9fc8f9-3777-43d6-90c5-454a623db94a
Ruiz Moreno, J.M.
52fc6d59-8a5c-42c5-8aa8-63ac16e927b8
Dugel, P.
5b0ebd4e-2839-4a60-a69d-4fcbf412e1ee
Lotery, A.
5ecc2d2d-d0b4-468f-ad2c-df7156f8e514
on behalf of the FAME study group, None
d59524d9-34ac-4a6a-9b46-bd0179d2de85
Yang, Y.
0c661323-7e23-41c6-a9a2-b4479fd74ef1
Bailey, C.
e4c10869-bc21-42d7-b5fb-829bd810dbc2
Holz, F.G.
5900cb42-0be2-4362-89b0-98d8a9d0fe8e
Eter, N.
617b04ec-17cf-49df-99ec-b3b30814f9ff
Weber, M.
9d3b3715-fde2-4207-9315-f26ed61ddd71
Baker, C.
04dda9b5-d169-4c54-a963-d97eae49da33
Kiss, S.
dc2ac738-edd3-4c19-9ae7-f639d0205f08
Menchini, U.
7a9fc8f9-3777-43d6-90c5-454a623db94a
Ruiz Moreno, J.M.
52fc6d59-8a5c-42c5-8aa8-63ac16e927b8
Dugel, P.
5b0ebd4e-2839-4a60-a69d-4fcbf412e1ee
Lotery, A.
5ecc2d2d-d0b4-468f-ad2c-df7156f8e514
on behalf of the FAME study group, None
d59524d9-34ac-4a6a-9b46-bd0179d2de85

Yang, Y., Bailey, C., Holz, F.G., Eter, N., Weber, M., Baker, C., Kiss, S., Menchini, U., Ruiz Moreno, J.M., Dugel, P., Lotery, A. and on behalf of the FAME study group, None (2015) Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants. Eye, 29 (9), 1173-1180. (doi:10.1038/eye.2015.98). (PMID:26113503)

Record type: Article

Abstract

Purpose: Diabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2??g/day FAc implant.

Methods: This analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration.

Results: Best corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ?3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline.

Conclusions: These data support the use of 0.2??g/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract.

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Accepted/In Press date: 6 May 2015
e-pub ahead of print date: 26 June 2015
Published date: 29 September 2015
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 390410
URI: http://eprints.soton.ac.uk/id/eprint/390410
ISSN: 0950-222X
PURE UUID: 73d7c399-e55f-472c-8043-b5babba846ff
ORCID for A. Lotery: ORCID iD orcid.org/0000-0001-5541-4305

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Date deposited: 01 Apr 2016 10:57
Last modified: 26 Nov 2019 01:48

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Contributors

Author: Y. Yang
Author: C. Bailey
Author: F.G. Holz
Author: N. Eter
Author: M. Weber
Author: C. Baker
Author: S. Kiss
Author: U. Menchini
Author: J.M. Ruiz Moreno
Author: P. Dugel
Author: A. Lotery ORCID iD
Author: None on behalf of the FAME study group

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