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Daniel Ferraz, Sr., Lisa Vasquez, Sr., Augusto Motta, Sr., Rony Preti, Sr., Celso Morita, Sr., Otacilio O. Maia Júnior, Sr., Walter Takahashi, Sr.; Comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with Proliferative Diabetic Retinopathy (PDR): Short Term Results. Invest. Ophthalmol. Vis. Sci. 2012;53(14):3281.
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Evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe PDR by the mean change in BCVA and differences in Optic Coherence Tomography (OCT) retinal thickness and total macular volume at week 4 and 12 compared to baseline.
Prospective, randomized, comparative and interventional study. At the baseline and follow up visits (week 4 and 12), the patients underwent complete ophthalmic examination (including ETDRS Best Corrected Visual Acuity (BCVA) measurements, applanation tonometry, non dilated and dilated slit-lamp examinations, indirect fundus examination, and OCT evaluation). All patients were treated with bilateral laser photocoagulation consisting of full scatter PRP treatment performed in three episodes according to ETDRS guideline. An intravitreal injection of ranibizumab were performed in one of the eyes - as defined per a randomization list at week 1 and 3 (group 1 - PRP and group 2 - RPR + Intravitreal Ranibizumab) . The fellow eye received a sham injection. The x2 and Student t test were applied to compare the differences between two groups to categorical and continuous variables, respectively. The null hypothesis were rejected for P values of <.05.
Thirty patients (n= 60 eyes) completed the 12-week study follow-up period. At the baseline the Best Corrected Visual Acuity (letters) was 36 ± 16,93 and 39 ± 12,52 (p=0.603); and central macular thickness CTM (μm) was 204±20,3 and 192±31,1 (p=0,777), in the PRP and PRP + IVR groups, respectively. Total Macular Volume mm3 (TMV) was 7.254 ± 244,52 in group 1 and 6974 ± 292,47 in Group 2 (p=0,122). The BCVA at week 4 was 40 ± 11,64 letters in group 1 and 42 ± 13,45 in group 2 (p=0,053); at week 12 was 39 ± 10,35 in group 1 and 37 ± 12,47 in group 2 (p=0,455). The CMT and TMV observed in the PRP group at week 4 were 220± 27,09 (p=0,172) and 8.463 ± 301,33 (p=0,039), respectively. In PRP + IVR group, the CMT and TMV were 224± 26,87 (p=0,02) e 7.662± 312,32 (p=0,03). At week 12, the CMT was 222± 31,43 (p=0,172) and TVM was 7.761 ± 307,34 (p=0,502) in group 1 and 200± 29,07 (p=0,03) and 7.572± 334,75 (p=0,05) in group 2.
Intravitreal ranibizumab plus PRP were associated with not OCT worsening at week 4 and 12 compared with PRP alone in eyes with high-risk PDR, but did not appear to influence the visual acuity in eyes treated with PRP.
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