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Manju N. Chandran, Gulrez Ansari, Narendran Nair, Nitin Jain, Leena Bhat, Bhavani Mathapati, Emily Turton, Geeta Menon; A Prospective Randomised Controlled Trial Assessing The Efficacy Of Intravitreal Bevacizumab In Patients With Minimally Classic And Occult Choroidal Neovascularisation Secondary To Age Related Macular Degeneration ( Bemoc Trial). Invest. Ophthalmol. Vis. Sci. 2011;52(14):3540.
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A prospective randomised controlled trial assessing the efficacy and comparing the two protocols of treatment with intravitreal Bevacizumab in patients with minimally classic and occult choroidal neovascularisation (CNV) secondary to age related macular degeneration (AMD).
100 patients were randomised into two groups and enrolled into this prospective study. Group I had Bevacizumab administered as three consecutive injections at 6 weekly intervals and thereafter as needed. Group II had Bevacizumab administered as needed after the first injection. Evaluation consisted of a complete ophthalmic examination, including Visual Acuity( VA) measured by Early Treatment Diabetic Retinopathy Study (ETDRS) charts, and Optical Coherence Tomography ( OCT) at baseline and followed up every six weeks for 12 months. Treatment consisted of pars plana injection of 1.25 mg of Bevacizumab /. 05ml. Primary objective was to explore best treatment plan of Bevacizumab in reduction of Central Macular Thickness (CMT) from baseline to 12months. In both groups the retreatment criteria was CMT exceeding 250u on OCT.
There was significant reduction in CMT from baseline in Group I and Group II (mean reduction, respectively: 81.45& 105.36 with p < 0.0001 in both cases). These two sets of reductions were not statistically significantly distinguished (p = 0.0678) between the groups Mean VA change was not statistically significant between the groups.. 22% patients in the Group I compared with the 16% in the GroupII gained 10 or more letters. 84% of the patients in Group I and 67% of the patients in Group II achieved stability in vision.
Intravitreal Bevacizumab 1.25mg is an effective treatment for CNV. Reduction in CMT was statistically significant in both groups .However there was no significant difference in mean change in VA at the end of 12 months.
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