title: Long-term safety and efficacy of ziv-aflibercept in retinal diseases.
abstract: To investigate the long-term safety of intravitreal ziv-aflibercept in eyes receiving six or more intravitreal injections of ziv-aflibercept, an off-label substitute to the approved aflibercept.
  
  
  
  Consecutive patients with retinal disease receiving six or more of intravitreal 0.05 mL ziv-aflibercept (1.25 mg) injections were followed monthly in three centres. Outcome measures were best-corrected visual acuity (BCVA) (logarithm of the minimum angle of resolution (logMar)) and central macular thickness (CMT) on spectral domain optical coherence tomography and monitoring for ocular inflammation, progression of lens opacities and intraocular pressure rise. Paired comparison was done using Wilcoxon signed-rank test calculator.
  
  
  
  Sixty-five eyes of 60 consecutive patients received a mean of 8.4 (6-17) intravitreal injections with a baseline mean logMAR BCVA of 0.98±0.56 and CMT 432.7±163.0 μm and followed for a mean of 9.2 months (range 6-18 months). After the sixth injection, mean BCVA improved to 0.57±0.36 (p=0.001) and CMT decreased to 274.8±117.8 μm (p=0.0001). At the 9-month follow-up, mean BCVA improved to 0.62±0.37 (p=0.0004) and mean CMT decreased to 292.0±160.9 μm (p<0.01) in 19 eyes. At 1 year, mean BCVA was 0.73±0.52 and CMT 311.6±232.5 μm in seven eyes. Intraocular pressures did not increase after injections. One subject developed transient mild iritis at the fourth injection but not on subsequent injections. No lens opacity progression or endophthalmitis was noted. Systemic adverse effects were not registered.
  
  
  
  Repeated intravitreal injections of ziv-aflibercept appear tolerable, safe and efficacious in the therapy of retinal disease.
authors.affiliation: Department of Ophthalmology, American University of Beirut, Beirut, Lebanon.|Department of Ophthalmology, Rafic Hariri University Hospital, Beirut, Lebanon.
authors.forename: Ahmad M
authors.initials: AM
authors.lastname: Mansour
authors.affiliation: Department of Ophthalmology, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.
authors.forename: Mohammed
authors.identifier: 0000-0003-4231-2566
authors.initials: M
authors.lastname: Ashraf
authors.affiliation: Smt. Kanuri Santhamma Centre for Vitreoretinal Diseases, LV Prasad Eye Institute, Hyderabad, Andhra Pradesh, India.
authors.forename: Chintan J
authors.identifier: 0000-0001-5475-2089
authors.initials: CJ
authors.lastname: Dedhia
authors.affiliation: Department of Statistics and Research Methodology, Lebanese American University, Beirut, Lebanon.|Department of Statistics and Research Methodology, Lebanese University, Beirut, Lebanon.
authors.forename: Abdulrazzak
authors.initials: A
authors.lastname: Charbaji
authors.affiliation: Department of Ophthalmology, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.
authors.forename: Ahmed A R
authors.identifier: 0000-0002-1664-704X
authors.initials: AAR
authors.lastname: Souka
authors.affiliation: Smt. Kanuri Santhamma Centre for Vitreoretinal Diseases, LV Prasad Eye Institute, Hyderabad, Andhra Pradesh, India.
authors.forename: Jay
authors.initials: J
authors.lastname: Chhablani
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000473:pathology; D008297:Male; D008875:Middle Aged; D040262:Receptors, Vascular Endothelial Growth Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D012164:Retinal Diseases / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D041623:Tomography, Optical Coherence; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor
keywords: Retina