Randomised trial of wide-field guided PRP for diabetic macular oedema treated with ranibizumab.


Journal

Eye (London, England)
ISSN: 1476-5454
Titre abrégé: Eye (Lond)
Pays: England
ID NLM: 8703986

Informations de publication

Date de publication:
06 2019
Historique:
received: 20 06 2018
accepted: 22 12 2018
revised: 12 11 2018
pubmed: 8 2 2019
medline: 2 10 2020
entrez: 8 2 2019
Statut: ppublish

Résumé

Diabetic macular oedema (DMO) is effectively treated with ranibizumab but multiple injections are required. Where there is also peripheral ischaemia, it has been promoted that targeted panretinal photocoagulation (PRP) may reduce the number of injections. Patients with optical coherence tomography confirmed DMO and Ultra-widefield Fundus Fluorescein Angiography confirmed peripheral retinal ischaemia were randomised to PRP plus ranibizumab or ranibizumab monotherapy. After three injections, repeat injections were given until the visual acuity was stable and the macula was dry. Re-treatment was given if there was a drop of visual acuity and/or a recurrence of intra-retinal fluid. The primary outcome was the number of repeat injections required after the first 6 months up until 1 year. There were 49 patients, 25 in the ranibizumab only group and 24 in the ranibizumab + PRP group recruited at seven UK sites. The average number of injections in the ranibizumab-only arm was 6.84 over 1 year and 2.52 between months 6 and 12. The average number of injections in the combined arm was 6.67, with the number of injections in the second 6 months 1.92. For the primary outcome, comparing the number of 6- to 12-month injections, the result was not statistically significant (p = 0.33). The addition of targeted PRP to areas of non-perfusion in a patient with DMO does not reduce the number of injections required in the first year. It seems most likely that local VEGF at the macula is the main cause of DMO.

Sections du résumé

BACKGROUND
Diabetic macular oedema (DMO) is effectively treated with ranibizumab but multiple injections are required. Where there is also peripheral ischaemia, it has been promoted that targeted panretinal photocoagulation (PRP) may reduce the number of injections.
METHOD
Patients with optical coherence tomography confirmed DMO and Ultra-widefield Fundus Fluorescein Angiography confirmed peripheral retinal ischaemia were randomised to PRP plus ranibizumab or ranibizumab monotherapy. After three injections, repeat injections were given until the visual acuity was stable and the macula was dry. Re-treatment was given if there was a drop of visual acuity and/or a recurrence of intra-retinal fluid. The primary outcome was the number of repeat injections required after the first 6 months up until 1 year.
RESULTS
There were 49 patients, 25 in the ranibizumab only group and 24 in the ranibizumab + PRP group recruited at seven UK sites. The average number of injections in the ranibizumab-only arm was 6.84 over 1 year and 2.52 between months 6 and 12. The average number of injections in the combined arm was 6.67, with the number of injections in the second 6 months 1.92. For the primary outcome, comparing the number of 6- to 12-month injections, the result was not statistically significant (p = 0.33).
CONCLUSION
The addition of targeted PRP to areas of non-perfusion in a patient with DMO does not reduce the number of injections required in the first year. It seems most likely that local VEGF at the macula is the main cause of DMO.

Identifiants

pubmed: 30728488
doi: 10.1038/s41433-019-0342-1
pii: 10.1038/s41433-019-0342-1
pmc: PMC6707207
doi:

Substances chimiques

Angiogenesis Inhibitors 0
Vascular Endothelial Growth Factor A 0
Ranibizumab ZL1R02VT79

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

930-937

Références

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pubmed: 23269405
Br J Ophthalmol. 2017 May;101(5):559-563
pubmed: 27531355
Ophthalmology. 2015 Jul;122(7):1426-37
pubmed: 25972260
Invest Ophthalmol Vis Sci. 2014 Jul 15;55(8):4741-6
pubmed: 25028357
Ophthalmologica. 2014 Nov 26;:
pubmed: 25427532
Br J Ophthalmol. 2012 May;96(5):694-8
pubmed: 22423055
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pubmed: 29336896
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pubmed: 21459215
Br J Ophthalmol. 2015 Dec;99(12):1606-9
pubmed: 26271269
Ophthalmology. 2010 Jun;117(6):1064-1077.e35
pubmed: 20427088

Auteurs

S James Talks (SJ)

Newcastle Eye Centre, Newcastle Upon Tyne NHS Hospitals Foundation Trust, Tyne and Wear, UK. James.talks@nuth.nhs.uk.

Devangna Bhatia (D)

Newcastle Eye Centre, Newcastle Upon Tyne NHS Hospitals Foundation Trust, Tyne and Wear, UK.

Geeta Menon (G)

Frimley Park Hospitals NHS Foundation Trust, Camberley, GU16 7UJ, UK.

Abosede Cole (A)

University Hospitals Bristol NHS Foundation Trust, Bristol, BS2 8AE, UK.

Haralabos Eleftheriadis (H)

King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK.

Louise Downey (L)

Hull Royal Infirmary, Hull and East Yorkshire Hospitals NHS Trust, Hull, HU3 2JZ, UK.

Ngai Victor Chong (NV)

Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.

Sobha Sivaprasad (S)

Moorfields Eye Hospital NHS Foundation Trust, London, EC1, UK.

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Classifications MeSH