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Meidong Zhu, Mark C. Gillies; Intravitreal Ranibizumab Injection For Patients With Triamcinolone Resistant Diabetic Macular Oedema: 12-month Results Of An Open Label, Non-comparative Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2012;53(14):398.
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To test the efficacy and safety of intravitreal injections of the VEGF inhibitor ranibizumab (Lucentis) for patients with diabetic macular oedema (DME) which had become resistant to intravitreal triamcinolone (IVTA).
After investigations to exclude any other cause of visual loss, we enrolled patients with DME which was resistant to IVTA into an open label study to administer intravitreal injections of 0.3 mg of ranibizumab at four weekly intervals with a minimum 4 injections planned with additional doses at the same interval if clinically indicated at the discretion of the investigator for up to 12 months. All patients were followed up to 12 months.The primary outcome was the improvement of best-corrected LogMAR visual acuity (BCVA) by 5 or more letters at 12 months compared with baseline. Secondary outcomes included incidence of moderate or severe adverse events and change in central macular thickness (CMT).
7 eyes of 5 patients were enrolled into the study. 12-month data were available for 6/7 (86%) eyes. For the eye with missing 12-month data, the last assessment was carried forward. Improvement of 5 or more letters of BCVA was found in 4/7 (57%) eyes treated with ranibizumab. The mean improvement in visual acuity was 13 letters at 52 week (SD=14.67, CI=3-23, P=0.06). 4/7 (57%) eyes had CMT reduction of more than 50 micron and 3/7 (43%) eyes had CMT reduction greater than 100 micron. The mean CMT reduction was 104 micron (SD=201.2, CI=45-253 micron, P=0.22). There were no moderate or severe adverse events associated with ranibizumab treatment. The mean IOP remained unchanged during the treatment period. All eyes were pseudophakic at baseline.
Ranibizumab appeared safe when used on the patients with DME that had become resistant to IVTA treatment. It also resulted in improvement of vision and reduction of CMT in the majority of treated eyes. Differences in visual acuity at 12 months were of borderline significance, likely due to small numbers.
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