Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema.

BACKGROUND AND OBJECTIVE: To evaluate the safety and efficacy of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Bridgewater, NJ/Regeneron Pharmaceuticals, Tarrytown, NY) in the treatment of refractory diabetic macular edema (DME). PATIENTS AND METHODS: Retrospective case series looking at the safety of ziv-aflibercept in patients with DME refractory to previous anti-vascular endothelial growth factor (VEGF) therapy. Detailed ophthalmologic examination, best-corrected visual acuity, and optical coherence tomography measurements were performed pre-switch, as well as at each monthly follow-up visit. RESULTS: The study included 34 eyes of 26 patients. The mean number of ziv-aflibercept injections post-switch was 2.03 injections. Visual acuity improved from a mean of 0.63 logMAR pre-switch to 0.51 logMAR after the first visit and 0.46 logMAR after the second visit post-switch (P < .084). Macular thickness improved from a mean of 513.79 µm to 411.79 µm (P = .006) on the first visit and 426.76 µm (P = .029) after the second visit post-switch. No adverse ocular or systemic side effects were reported on any of the follow visits. CONCLUSION: Ziv-aflibercept appears to be safe and effective in patients with refractory DME previously treated with other anti-VEGF agents in the short term. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:399-405.].

Long-term safety and efficacy of ziv-aflibercept in retinal diseases.

AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Repeated intravitreal injections of ziv-aflibercept appear tolerable, safe and efficacious in the therapy of retinal disease.

Short-Term Effects of Early Switching to Ranibizumab or Aflibercept in Diabetic Macular Edema Cases With Non-Response to Bevacizumab.

BACKGROUND AND OBJECTIVES: To study the effect of early switching to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in cases of diabetic macular edema (DME) that have shown no response to bevacizumab (Avastin; Genentech, South San Francisco, CA). PATIENTS AND METHODS: A retrospective study involving 59 eyes of 45 patients with DME previously treated with bevacizumab. Patients were switched either to ranibizumab or aflibercept. Detailed ophthalmological examination, best-corrected visual acuity (BCVA), and optical coherence tomography (Spectralis; Heidelberg Engineering, Heidelberg, Germany) were performed prior to and 1 month post-switch. RESULTS: Fifty-nine eyes of 45 patients were included in the study, of whom 14 patients (17 eyes) were switched to aflibercept and 31 patients (42 eyes) were switched to ranibizumab. Post-switch, there was a statistically significant improvement in the BCVA in the combined group (aflibercept and ranibizumab), as well as in the ranibizumab group alone. In addition, there was a statistically significant decrease in the central subfield thickness (CST) in the combined group, as well as in the ranibizumab and aflibercept groups individually. There was no significant difference with regard to the change in macular thickness or BCVA between the aflibercept and ranibizumab groups. In addition, neither the pre-switch central macular thickness, previous number of injections, nor the pre-switch visual acuity affected the response to switching. CONCLUSION: Aflibercept and ranibizumab both appear to be effective for patients showing no initial response to bevacizumab. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:230-236.].

Steroids in Central Retinal Vein Occlusion: Is There a Role in Current Treatment Practice?

With the current widespread use of anti-VEGFs in the treatment of central retinal vein occlusion (CRVO), the role for steroids has become greatly diminished. Recent large scale randomized control trials (RCTs) have established the efficacy and safety of anti-VEGFs in the treatment of CRVO. Steroids are known to cause elevations in intraocular pressure as well as increase the risk of cataract formation. With that in mind many ophthalmologists are injecting steroids less frequently. This paper aims to review some of the data pertaining to the use of steroids either as a first line monotherapy, adjunct therapy, or an alternative therapy to help answer the question: Is there currently any role for steroids in the management of CRVO?

Correlation between optical coherence tomography and autofluorescence in acute posterior multifocal placoid pigment epitheliopathy.

PURPOSE: To report a case of bilateral acute posterior multifocal placoid pigment epitheliopathy (APMPPE) evaluated by optical coherence tomography (OCT), fundus autofluorescence (AF) and microperimetry, both in the acute phase and after resolution of symptoms. METHODS: Complete ophthalmological evaluation, including fluorescein angiography, OCT, AF, and microperimetry upon presentation and 1 month later, after lesions have subsided. An attempt to correlate the findings on presentation and changes after resolution is performed using the results of these new investigational techniques. RESULTS: APMPPE showed hyperreflectance in OCT at the level of the outer retinal layers, without increase in retinal thickness. AF revealed early decreased fluorescence due to a masking effect, and later reveals increased fluorescence after resolution of OCT findings. Function is disturbed at the lesion sites, as shown by microperimetry, and later returns to near normal values on microperimetry. CONCLUSION: APMPPE shows outer retinal layers changes on OCT, which resolve totally after subsidence of the acute phase. AF shows areas of increased fluorescence after resolution, with near normal return of function on microperimetry.