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Effectiveness and safety of dexamethasone implants for postsurgical macular oedema including Irvine–Gass syndrome: the EPISODIC-2 study
  1. David Bellocq1,2,
  2. Vincent Pierre-Kahn3,
  3. Frédéric Matonti4,
  4. Carole Burillon5,
  5. Nicolas Voirin6,7,
  6. Corinne Dot8,
  7. Jad Akesbi9,
  8. Solange Milazzo10,
  9. Stéphanie Baillif11,
  10. Vincent Soler12,
  11. Benjamin Wolff13,
  12. Claire Scemama14,
  13. Ariane Malclès1,2,
  14. Michel Weber15,
  15. Laurent Kodjikian1,2
  1. 1Department of Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, University of Lyon I, Lyon, France
  2. 2CNRS UMR 5510 Mateis, Villeurbanne, France
  3. 3Department of Ophthalmology, Hôpital Foch, Suresnes, France
  4. 4Department of Ophthalmology, Nord Hospital, Aix Marseille University, Institut de Neurosciences de la Timone, CNRS/ UMR7289, Marseille, France
  5. 5Department of Ophthalmology, Edouard Herriot Hospital, University of Lyon I, Institut de Biologie et Chimie des Protéines, CNRS/ UMR5086, Lyon, France
  6. 6Hospices Civils de Lyon, Service de Biostatistique, Lyon, France
  7. 7Laboratoire de Biométrie et Biologie Evolutive, CNRS, UMR 5558, Equipe Biostatistique-Santé, Villeurbanne, France
  8. 8Department of Ophthalmology, Desgenettes military Hospital, University of Val de Grâce, Paris, France
  9. 9Department of Ophthalmology, XV XX Ophthalmic National Hospital Center, Paris, France
  10. 10Department of Ophthalmology, University of Picardie Jules Verne, CHU Amiens Picardie -Site Sud D408 Amiens cedex 1 80054 . France. Center n° 86 of network EVICR-net, Amiens, France
  11. 11Department of Ophthalmology, Saint Roch University Hospital, Nice Sophia Antipolis, France
  12. 12Department of Ophthalmology, University Hospital, Toulouse, France
  13. 13Centre Ophtalmologique Maison Rouge, Strasbourg, France
  14. 14Department of Ophthalmology, Fondation Rotschild, Paris, France
  15. 15Department of Ophthalmology, University Hospital of Nantes, Nantes, France
  1. Correspondence to Professeur Laurent Kodjikian, Service d'Ophtalmologie, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix Rousse, 69317 Lyon, Cedex 04, France; kodjikian.laurent{at}wanadoo.fr

Abstract

Aim To assess the effectiveness of intravitreal dexamethasone implants for treating postsurgical macular oedema (PSMO) including Irvine–Gass syndrome and determining the predictive factors of treatment response.

Methods Descriptive, observational, retrospective, consecutive, uncontrolled, multicentre, national case series. One hundred patients were included between April 2011 and June 2014, with a minimum of 1-year follow-up. Patients received dexamethasone implant 0.7 mg at baseline. Clinical characteristics, best-corrected visual acuity (BCVA), central subfield macular thickness (CSMT) and intraocular pressure were measured at each visit. The main outcome measure was the change in BCVA (Early Treatment of Diabetic Retinopathy Study (ETDRS) letters: L). An analysis of predictive factors of treatment response is also provided.

Results Mean improvement in BCVA was 9.6 (±10.6) L at month 6 and 10.3 (±10.7) L at month 12 (p<0.001). The proportion of eyes with gains in BCVA of 15 or more letters was 32.5% and 37.5% at months 6 and 12, respectively. The mean reduction in CSMT was 135.2 and 160.9 µm at months 6 and 12, respectively (p<0.001). Thirty-seven per cent of patients did not need a second injection after the first injection during follow-up. The presence of at least one PSMO risk factor decreases the probability of a gain in visual acuity (VA) ≥10 L (p=0.006). Initial VA ≤50 L at baseline and non-naïve status decrease the probability of having only one injection during follow-up (p=0.044).

Conclusions The significant gain in BCVA from baseline achieved at month 6 was maintained at month 12 after intravitreal injection of dexamethasone implant. Naïve status seems to be a good predictive factor of treatment response.

  • Inflammation
  • Macula
  • Drugs

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Footnotes

  • Contributors DB and LK were the principal investigators who conceived and designed the study. NV was the trial statistician and undertook the analyses. DB, LK, VP-K, FM, CB, CD, JA, SM, SB, VS, BW, CS, AM and MW participated to patients’ recruitment. This manuscript was drafted by DB, revised by LK and approved by all living authors.

  • Competing interests VP-K––has sat on advisory boards and received lecture fees from Allergan, Bayer and Novartis; FM––investigator for trials sponsored by Novartis, Bayer and Alcon; has sat on advisory boards for Allergan and Bayer; received lecture fees from Allergan, Bayer and Novartis; CD––reports personal fees from Allergan, Alcon, Bayer and Novartis, outside the submitted work; JA––co-investigator for the trial sponsored by Novartis; has sat on advisory boards for Allergan and Bayer; received lecture fees from Allergan, Bayer and Novartis; SM––investigator for trials sponsored by Bayer and Novartis; received lecture fees from Alcon, Allergan, Bayer, Essilor and Novartis; SB––sat on advisory boards for Novartis, Bayer and Allergan; BW––sat on advisory boards for Novartis; MW––has sat on advisory boards for Alcon, Alimera, Allergan, Bayer, FCI, Novartis and Théa; received lecture fees from Alcon, Alimera, Allergan, Bayer, Novartis and Théa; LK––principal investigator for trials sponsored by Novartis, Bausch&Lomb, Théa and Alcon; has sat on advisory boards for Alcon, Alimera, Allergan, Bayer, Bausch&Lomb, Novartis and Théa; received lecture fees from Alcon, Alimera, Allergan, Bayer, Bausch&Lomb, Novartis and Théa.

  • Provenance and peer review Not commissioned; externally peer reviewed.