title: Dexamethasone intravitreal implant in retinal vein occlusion: real-life data from a prospective, multicenter clinical trial.
abstract: OBJECTIVE
  To evaluate the relationship between duration of macular edema associated with retinal vein occlusion (RVO) and the achievement of vision gain in patients receiving dexamethasone intravitreal implant (DEX implant) in real-world clinical practice, and to define patterns of use of DEX implant and its efficacy and safety in the treatment of patients with RVO in clinical practice.
  
  
  METHODS
  This prospective, open-label, multicenter, 6-month observational phase IV study conducted at 70 sites in Germany enrolled patients diagnosed with macular edema following branch or central RVO (BRVO, CRVO) who were given DEX implant. Follow-up visits and evaluations occurred in accordance with normal clinical practice. Re-treatment with DEX implant and use of other RVO therapies was at the discretion of the treating physician. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline at week 12.
  
  
  RESULTS
  The analysis population consisted of 573 patients (64 % BRVO, 36 % CRVO). Patients received a mean of 1.17 DEX implant treatments during the study period; 84.3 % of patients received a single DEX implant and 19.9 % received adjunctive other RVO treatment. Among patients with analyzable BCVA data at baseline and week 12 (n = 351), mean change from baseline BCVA at week 12 was -0.16 (standard deviation, 0.30) logMAR (+7.8 approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters) (p < 0.001), and 33.9 % of patients had gained at least 3 lines in BCVA from baseline. Mean change from baseline BCVA at week 12 was +9.5, +7.3, and +5.4 approximate ETDRS letters in patients with macular edema duration < 90 days, from 90 to 180 days, and >180 days respectively. Improvement in BCVA through week 24 and decreases in central retinal thickness were seen in both BRVO and CRVO. The most common adverse drug reaction was increased intraocular pressure. No glaucoma incisional surgeries were required.
  
  
  CONCLUSIONS
  DEX implant was effective in improving BCVA and central retinal thickness in patients with BRVO and CRVO in real-world clinical practice. The largest gains in BCVA over 6 months occurred in patients with recent onset macular edema, confirming the benefit of early treatment. DEX implant was well tolerated and had an acceptable safety profile.
authors.affiliation: Department of Ophthalmology, University of Münster Medical School, Domagkstr 15, D-48149, Münster, Germany. eter@uni-muenster.de.
authors.forename: Nicole
authors.initials: N
authors.lastname: Eter
authors.affiliation: Eye Hospital St. Joseph-Stift, Bremen, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Mohr
authors.affiliation: Augenabteilung, Sankt Gertrauden Krankenhaus, Berlin, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Wachtlin
authors.affiliation: University Eye Care Hospital, Göttingen, Germany.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Feltgen
authors.affiliation: Allergan plc, Marlow, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Shirlaw
authors.affiliation: Allergan plc, Marlow, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Leaback
mesh_terms: D000368:Aged; D003907:Dexamethasone / Q000008:administration & dosage*; D004343:Drug Implants; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012160:Retina / Q000187:drug effects / Q000473:pathology*; D012170:Retinal Vein Occlusion / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity; D014822:Vitreous Body
chemical_list: D004343:Drug Implants; D005938:Glucocorticoids; D003907:Dexamethasone
keywords: Branch retinal vein occlusion; Central retinal thickness; Central retinal vein occlusion; Dexamethasone; Intravitreal; Macular edema