| Objective:To evaluate the efficacy in reducing the retinal thickness and the differences of two dosing regimens(monthly treatment regimen and "3 + PRN" as needed treatment regimen) in the treatment of wet age-related macular degeneration with ranibizumab(0.5mg),and explore the the value of standards in the OCT on the retreatment of wet age-related macular degeneration.Methods:32 patients(32 eyes) who were diagnosed with wet macular degeneration in the First Affiliated Hospital of Nanchang University from the 2012 / 09 to 2013 / 11,they were randomly divided into two groups by the ratio of 1: 1. Group A(monthly treatment group): intravitreal ranibizumab(Lucentis), monthly.;Group B( "3 + PRN" as needed treatment regimen group): intravitreal ranibizumab(Lucentis), three consecutive months initially, then the treatment according to the re-treatment standards. Follow-up includes: BCVA, IOP, OCT, FFA, fundus photography, slit lamp examination. The follow-up period is 12-month.Statistical analysis.Result:1. The mean best corrected visual acuity(BCVA) of the two groups was improved after treatment, the maximum margin of increase appeared at three months,3 months to 6 months postoperatively still significantly improved, and then stabilized.In the group A,BCVA increased 3.06 ± 7.24,12.56 ± 6.91,18.13 ±6.23,18.93 ± 7.01 letters at 1 month, 3 months, 6 months, 12 months postoperatively.In the group B,BCVA increased 2.06 ± 2.84,12.69 ± 9.09,15.81 ± 10.78,16.94 ±11.35 letters at 1 month, 3 months,6 months, 12 months postoperatively.There was no significant difference between BCVA the first month postoperatively and preoperatively(P>0.05).3 months, 6 months, 12 months postoperatively, compared with preoperative BCVA were significantly difference(P < 0.05), there was no significant difference in improving BCVA of the two injection regimens(P>0.05).At the 12 months,in the group A, visual acuity improved ≥15 letters in 12 eyes(75%),visual acuity improved <15 letters in 3 eyes(18.75%), visual acuity decreased ≤5letters in 1 eye(6.25 %);in the group B, visual acuity improved ≥15 letters in 10eyes(62.5%), visual acuity improved <15 letters in 5 eyes(31.25%), visual acuity decreased ≤ 5 letters in 1 eye(6.25 %), there was no significant difference in constituent ratio of visual changes between the two groups( P=0.836).2. The mean central macular retinal thickness(CMT) was decreased from the start of treatment, and reduced the most at 3 months postoperatively, and then stabilized. In the group A,CMT decreased 132.38 ± 113.87,163.19 ± 123.67,167.31 ±122.74μm at 3 months, 6 months, 12 months postoperatively. In the group B,CMT decreased 75.56 ± 90.19,91.81 ± 108.67,110.37 ± 106.39μm,at 3 months, 6 months,12 months postoperatively. 3 months, 6 months, 12 months postoperatively, compared with preoperative CMT were significantly difference(P < 0.05).The two injection regimens in decreasing CMT was no significant difference(P>0.05)..3. The mean retinal thickness of retinal lesions uplift the highest point(HLT)was decreased from the start of treatment, and reduced the most at 3 months postoperatively, and then stabilized. In the group A,HLT decreased 210.63±262.02、266.81±301.30 、 275.06±315.57 μ m, at 3 months, 6 months, 12 months postoperatively. In the group B,HLT decreased 111.38±106.39 、 125.75±74.31 、132.19±98.22μm. at 3 months, 6 months, 12 months postoperatively. 3 months, 6months, 12 months postoperatively, compared with preoperative HLT were significantly difference(P<0.05).The two injection regimens in decreasing HLT was no significant difference(P>0.05).4. The mean central of lesion retinal thickness(CLT) was decreased from the start of treatment, and reduced the most at 3 months postoperatively, and then stabilized. In the group A,CLT decreased 147.31±126.78 、 176.44±140.75 、183.81±145.16μm, at 3 months, 6 months, 12 months postoperatively. In the group B,CLT decreased 108.31±64.10、133.81±99.66、141.25±89.56μm at 3 months, 6months, 12 months postoperatively. 3 months, 6 months, 12 months postoperatively,compared with preoperative CLT were significantly difference(P < 0.05).The two injection regimens in decreasing CLT was no significant difference(P>0.05).5. The mean CNV leakage area on the fundus fluorescein angiography(S)from the start of treatment until after 12 months was significantly reduced after 6months, and then stabilized. In the group A,S decreased 1.32 ± 0.29,1.89 ± 0.32mm2 at 6 months, 12 months postoperatively. In the group B, S decreased 0.80 ± 0.24,1.41± 0.36 mm2. at 6 months, 12 months postoperatively. 6 months, 12 months postoperatively, compared with preoperative S were significantly difference(P<0.05),The two injection regimens in reducing S was no significant difference(P>0.05).6. The correlations between the decrease in OCT central of lesion retinal thickness and the improvement in visual acuity :(in the group A) there were significant correlations the subsequent improvement in visual acuity seen at twelve months with the decrease in central of lesion retinal thickness at six month(Pearson,r= 0.640, P=0.008) and at twelve months(Pearson,r =0.629, P =0.009).7.The average injection number is 12 ± 0.00 times in the group A and 7.38 ± 2.58 times in the group B at 12 month. There was significant difference between the two groups(P<0.05).8. After the 3 initial treatment in the group B, the number of visual acuity and OCT follow-up examination were 144 times and the total number of drug injection was 70 times. Sorting the data of the re-treatment standards in the group B : vision loss ≥5 ETDRS letters appears 3 times(4.3%);cystic retinal edema layer appears 59times(84.3%);subretinal fluid appears 13 times(18.6%);under the fovea diffuse thickening or OCT retinal thickening was found in any direction ≥100μm appear 0times(0%);the serous pigment epithelium detachment expanded appears 3 times(4.3%);bleeding or retinal layer of new subretinal appears 6 times(8.6%).9. Complications: only one patient occurs subconjunctival hemorrhage in the group A(3.1%). Symptomatic treatment after one week returning to normal. Other ocular and systemic adverse reactions were not observed.Conclusion:1. The retinal thickness of retinal lesions uplift the highest point(HLT) and the central of lesion retinal thickness(CLT) can be used to supplement the re-treatment standards.2. The central of lesion retinal thickness decline was associated with vision improved.3、Treatment of wet AMD with ranibizumab can reduce the retinal thickness of lesions significantly and the effectiveness of two regimens(monthly treatment injection regimen and “3+PRN” as needed treatment injection regimen) is considerable.4. The treatment of wet age-related macular degeneration by intravitrealing injection of ranibizumab is safe and reliable. |
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