PMID- 29080915 OWN - NLM STAT- MEDLINE DCOM- 20180112 LR - 20220408 IS - 1435-702X (Electronic) IS - 0721-832X (Print) IS - 0721-832X (Linking) VI - 256 IP - 1 DP - 2018 Jan TI - Detailed analysis of retinal morphology in patients with diabetic macular edema (DME) randomized to ranibizumab or triamcinolone treatment. PG - 49-58 LID - 10.1007/s00417-017-3828-1 [doi] AB - PURPOSE: Our purpose was to compare the impact in diabetic macula edema (DME) of two intravitreal drugs (0.5 mg ranibizumab vs. 8 mg triamcinolone) on changes in retinal morphology in spectral-domain optical coherence tomography (SD OCT) images, color fundus photography (CF) and fluorescein angiography (FA) images during a 1-year follow-up. METHODS: Post hoc analysis was conducted of morphologic characteristics in OCT, FA and CF images of eyes with a center involving DME that were included in a prospective double-masked randomized trial. Eligible patients were divided at random into two groups receiving either pro re nata treatment with 0.5 mg ranibizumab or 8 mg triamcinolone after a fixed loading dose. OCT and CF images were acquired at monthly visits and FA images every three months. RESULTS: Twenty-five eyes of 25 patients (ranibizumab: n = 10; triamcinolone: n = 15) were included in this study. Patients treated with ranibizumab showed better visual acuity results after 12 months than patients receiving triamcinolone (p = 0.015) although edema reduction was similar (p = 0.426) in both groups. The initial effect on macular edema shedding after a single ranibizumab injection could be amplified with the following two injections of the loading dose. After a single injection of triamcinolone the beneficial initial effect on the macula edema faded within 3 months. Subretinal fluid and INL cystoid spaces diminished early in the course of treatment while fluid accumulation in the ONL seemed to be more persistent in both treatment arms. In FA, the area of leakage diminished significantly in both treatment arms. After repeated injections the morphologic OCT and FA characteristics of the treatment arms converged. CONCLUSIONS: Despite the higher dosage of triamcinolone, both therapies were safe and effective for treating diabetic macular edema. Fluid accumulation in the INL and subretinal space was more responsive to therapy than fluid accumulation in the ONL. Clinicaltrials.gov : NCT00682539. FAU - Karst, Sonja G AU - Karst SG AD - Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, Austria. FAU - Lammer, Jan AU - Lammer J AD - Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, Austria. FAU - Mitsch, Christoph AU - Mitsch C AD - Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, Austria. FAU - Schober, Manuela AU - Schober M AD - Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, Austria. FAU - Mehta, Janhvi AU - Mehta J AD - Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, Austria. AD - Jaslok Hospital and Research Centre, Mumbai, India. FAU - Scholda, Christoph AU - Scholda C AD - Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, Austria. FAU - Kundi, Michael AU - Kundi M AD - Center of Public Health, Medical University Vienna, Vienna, Austria. FAU - Kriechbaum, Katharina AU - Kriechbaum K AD - Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, Austria. FAU - Schmidt-Erfurth, Ursula AU - Schmidt-Erfurth U AD - Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, Austria. ursula.schmidt-erfurth@meduniwien.ac.at. LA - eng SI - ClinicalTrials.gov/NCT00682539 PT - Journal Article DEP - 20171028 PL - Germany TA - Graefes Arch Clin Exp Ophthalmol JT - Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie JID - 8205248 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Glucocorticoids) RN - F446C597KA (Triamcinolone Acetonide) RN - ZL1R02VT79 (Ranibizumab) SB - IM CIN - Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):1035-1037. PMID: 29353345 CIN - Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):1039-1040. PMID: 29368041 MH - Angiogenesis Inhibitors/administration & dosage MH - Diabetic Retinopathy/complications/*diagnosis/drug therapy MH - Double-Blind Method MH - Female MH - Fluorescein Angiography/methods MH - Follow-Up Studies MH - Fundus Oculi MH - Glucocorticoids/administration & dosage MH - Humans MH - Intravitreal Injections MH - Macula Lutea/*pathology MH - Macular Edema/*diagnosis/drug therapy/etiology MH - Male MH - Middle Aged MH - Prospective Studies MH - Ranibizumab/*administration & dosage MH - Time Factors MH - Tomography, Optical Coherence/methods MH - Treatment Outcome MH - Triamcinolone Acetonide/*administration & dosage MH - Visual Acuity PMC - PMC5748439 OTO - NOTNLM OT - Diabetic macula edema OT - Diabetic retinopathy OT - Fluorescein angiography OT - OCT OT - Ranibizumab OT - Triamcinolone COIS- CONFLICT OF INTEREST: Schmidt-Erfurth Novartis (C). All other authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers' bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript. ETHICAL APPROVAL: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. INFORMED CONSENT: Informed consent was obtained from all individual participants included in the study. FINANCIAL SUPPORT/INTEREST: None. EDAT- 2017/10/31 06:00 MHDA- 2018/01/13 06:00 PMCR- 2017/10/28 CRDT- 2017/10/30 06:00 PHST- 2017/06/30 00:00 [received] PHST- 2017/10/07 00:00 [accepted] PHST- 2017/09/18 00:00 [revised] PHST- 2017/10/31 06:00 [pubmed] PHST- 2018/01/13 06:00 [medline] PHST- 2017/10/30 06:00 [entrez] PHST- 2017/10/28 00:00 [pmc-release] AID - 10.1007/s00417-017-3828-1 [pii] AID - 3828 [pii] AID - 10.1007/s00417-017-3828-1 [doi] PST - ppublish SO - Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):49-58. doi: 10.1007/s00417-017-3828-1. Epub 2017 Oct 28.