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Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France.
Graefes Arch Clin Exp Ophthalmol. 2016 Dec; 254(12):2307-2318.GA

Abstract

PURPOSE

To evaluate patterns of use and long-term efficacy and safety of dexamethasone intravitreal implant (DEX implant) in the treatment of macular edema secondary to branch or central retinal vein occlusion (BRVO, CRVO) in French clinical practice.

METHODS

A 24-month, prospective, multicenter, longitudinal, observational study (LOUVRE) conducted at 48 randomly selected sites in metropolitan France enrolled consecutive adult patients with macular edema following retinal vein occlusion (RVO) who were treated with DEX implant at baseline. Re-treatment with DEX implant and use of other RVO treatments was at the physician's discretion. The primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline to month 6. Secondary endpoints included change in BCVA, intraocular pressure (IOP), adverse events, and RVO treatments administered through month 24.

RESULTS

The analysis population of 375 patients (53.9 % BRVO, 46.1 % CRVO) received a mean of 2.6 DEX implant injections over 2 years; mean time between injections was 6.6 months. Mean (SD) change in BCVA from baseline was 5.1 (19.0) letters at month 6 (p < 0.001) and 4.6 (22.3) letters at month 24 (p < 0.001). During the study, 208 patients (55.5 %) received treatment other than DEX implant for RVO, usually laser or ranibizumab therapy, with first use of other therapy occurring at a mean of 8.7 months. Mean change from baseline BCVA at month 6 was 5.5 letters (p < 0.001, N = 254) in patients who had received only DEX implant and 4.2 letters (p = 0.006, N = 121) in patients who had received additional other RVO treatment during the first 6 months. At month 24, mean change from baseline BCVA was +20.7 letters in patients treated with a single DEX implant only (p < 0.001), +4.9 letters in patients treated with ≥2 DEX implants only (p = 0.029), and +2.3 letters in patients treated with DEX implant and other RVO treatment (p = 0.143). The most common adverse events (incidence) were cataract progression (39.7 %) and increased IOP (34.4 %). No glaucoma incisional surgeries were required.

CONCLUSIONS

Efficacy and safety of DEX implant in the treatment of RVO-associated macular edema were demonstrated in the French clinical setting. Patients who switched from DEX implant to other RVO treatments did not have improved outcomes. The study is registered at ClinicalTrials.gov with the identifier NCT01618266.

Authors+Show Affiliations

Service d'Ophtalmologie, CHU de Bordeaux, Bordeaux, France. jean-francois.korobelnik@chu-bordeaux.fr. Univ. Bordeaux, ISPED, F-33000, Bordeaux, France. jean-francois.korobelnik@chu-bordeaux.fr. Inserm, U1219 - Bordeaux Population Health Research Center, F-33000, Bordeaux, France. jean-francois.korobelnik@chu-bordeaux.fr.La Croix-Rousse Hospital, University Hospital of Lyon, Lyon, France.Univ. Bordeaux, ISPED, F-33000, Bordeaux, France. Inserm, U1219 - Bordeaux Population Health Research Center, F-33000, Bordeaux, France.Clinique Honoré Cave, Montauban, France.Allergan plc, Marlow, UK.Biostatem, Castries, France.Allergan plc, Courbevoie, France.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27286894

Citation

Korobelnik, Jean-François, et al. "Two-year, Prospective, Multicenter Study of the Use of Dexamethasone Intravitreal Implant for Treatment of Macular Edema Secondary to Retinal Vein Occlusion in the Clinical Setting in France." Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Fur Klinische Und Experimentelle Ophthalmologie, vol. 254, no. 12, 2016, pp. 2307-2318.
Korobelnik JF, Kodjikian L, Delcourt C, et al. Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France. Graefes Arch Clin Exp Ophthalmol. 2016;254(12):2307-2318.
Korobelnik, J. F., Kodjikian, L., Delcourt, C., Gualino, V., Leaback, R., Pinchinat, S., & Velard, M. E. (2016). Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France. Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Fur Klinische Und Experimentelle Ophthalmologie, 254(12), 2307-2318.
Korobelnik JF, et al. Two-year, Prospective, Multicenter Study of the Use of Dexamethasone Intravitreal Implant for Treatment of Macular Edema Secondary to Retinal Vein Occlusion in the Clinical Setting in France. Graefes Arch Clin Exp Ophthalmol. 2016;254(12):2307-2318. PubMed PMID: 27286894.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France. AU - Korobelnik,Jean-François, AU - Kodjikian,Laurent, AU - Delcourt,Cécile, AU - Gualino,Vincent, AU - Leaback,Richard, AU - Pinchinat,Sybil, AU - Velard,Marie-Eve, Y1 - 2016/06/11/ PY - 2015/12/21/received PY - 2016/05/23/accepted PY - 2016/04/25/revised PY - 2016/6/12/pubmed PY - 2017/6/1/medline PY - 2016/6/12/entrez KW - Dexamethasone KW - Intravitreal KW - Macular edema KW - Observational KW - Prospective KW - Retinal vein occlusion SP - 2307 EP - 2318 JF - Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie JO - Graefes Arch Clin Exp Ophthalmol VL - 254 IS - 12 N2 - PURPOSE: To evaluate patterns of use and long-term efficacy and safety of dexamethasone intravitreal implant (DEX implant) in the treatment of macular edema secondary to branch or central retinal vein occlusion (BRVO, CRVO) in French clinical practice. METHODS: A 24-month, prospective, multicenter, longitudinal, observational study (LOUVRE) conducted at 48 randomly selected sites in metropolitan France enrolled consecutive adult patients with macular edema following retinal vein occlusion (RVO) who were treated with DEX implant at baseline. Re-treatment with DEX implant and use of other RVO treatments was at the physician's discretion. The primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline to month 6. Secondary endpoints included change in BCVA, intraocular pressure (IOP), adverse events, and RVO treatments administered through month 24. RESULTS: The analysis population of 375 patients (53.9 % BRVO, 46.1 % CRVO) received a mean of 2.6 DEX implant injections over 2 years; mean time between injections was 6.6 months. Mean (SD) change in BCVA from baseline was 5.1 (19.0) letters at month 6 (p < 0.001) and 4.6 (22.3) letters at month 24 (p < 0.001). During the study, 208 patients (55.5 %) received treatment other than DEX implant for RVO, usually laser or ranibizumab therapy, with first use of other therapy occurring at a mean of 8.7 months. Mean change from baseline BCVA at month 6 was 5.5 letters (p < 0.001, N = 254) in patients who had received only DEX implant and 4.2 letters (p = 0.006, N = 121) in patients who had received additional other RVO treatment during the first 6 months. At month 24, mean change from baseline BCVA was +20.7 letters in patients treated with a single DEX implant only (p < 0.001), +4.9 letters in patients treated with ≥2 DEX implants only (p = 0.029), and +2.3 letters in patients treated with DEX implant and other RVO treatment (p = 0.143). The most common adverse events (incidence) were cataract progression (39.7 %) and increased IOP (34.4 %). No glaucoma incisional surgeries were required. CONCLUSIONS: Efficacy and safety of DEX implant in the treatment of RVO-associated macular edema were demonstrated in the French clinical setting. Patients who switched from DEX implant to other RVO treatments did not have improved outcomes. The study is registered at ClinicalTrials.gov with the identifier NCT01618266. SN - 1435-702X UR - https://www.unboundmedicine.com/medline/citation/27286894/Two_year_prospective_multicenter_study_of_the_use_of_dexamethasone_intravitreal_implant_for_treatment_of_macular_edema_secondary_to_retinal_vein_occlusion_in_the_clinical_setting_in_France_ L2 - https://dx.doi.org/10.1007/s00417-016-3394-y DB - PRIME DP - Unbound Medicine ER -