ObjectiveTo observe the effect of preoperative intravitreal ranibizumab injection (IVR) on the operation duration of vitrectomy and postoperative vision for the treatment of proliferative diabetic retinopathy (PDR). MethodsA prospective study was carried out with the 90 PDR patients (90 eyes) who underwent vitrectomy. The 90 patients(90 eyes)were assigned to the vitrectomy only group(43 eyes) and the IVR combined with vitrectomy group (47 eyes). The IVR was performed 5-13 days prior to vitrectomy in the IVR combined with vitrectomy group. There were 15 eyes with fibrous proliferation PDR (FPDR), 16 eyes with advanced PDR (APDR) without involving the macular and 16 eyes with APDR involving the macular in the vitrectomy only group. There were 14 eyes with FPDR, 15 eyes with APDR without involving the macular and 14 eyes with APDR involving the macular patients in the IVR combined with vitrectomy group. All the eyes in the two groups were regularly operated by the same doctor to complete the vitrectomy. The start and end time of vitrectomy were recorded. The average follow-up time was 10 months. The changes of best corrected visual acuity (BCVA) before and 1, 3 and 6 months after surgery were compared between the two groups. ResultsThe duration of operation of the FPDR type (t=-8.300) and the APDR involving the macular type (t=-2.418) in the IVR combined with vitrectomy group was shorter than vitrectomy only group (P < 0.05). The comparison of duration of operation of the APDR without involving the macular type in the two groups has no statistically significant difference (t=-1.685, P > 0.05). At 1 month after surgery, the comparison of BCVA of the IVR combined vitrectomy group and the vitrectomy only group in APDR involving the macular type has no statistically significant difference (t=0.126, P > 0.05). At 3, 6 months after surgery, the BCVA of the IVR combined vitrectomy group in APDR involving the macular type was significantly better than the BCVA of the vitrectomy only group (t=8.014, 7.808; P < 0.05). At 1, 3, and 6 months after surgery, the BCVA of the IVR combined vitrectomy group in FPDR type (t=3.809, 1.831, 0.600) and APDR without involving the macular type (t=0.003, 1.092, 3.931) compared with pre-treatment, the difference were not statistically significant (P > 0.05); the BCVA in APDR without involving the macular type compared with pre-treatment, the difference was distinctly statistically significant (t=2.940, 4.162, 6.446; P < 0.05); the BCVA in APDR involving the macular type (t=0.953, 1.682, 1.835) compared with pre-treatment, the difference were not statistically significant (P > 0.05). ConclusionPreoperative IVR of PDR can shorten the operation duration and improve the BCVA of APDR involving the macular type.
Objective To study and compare the clinical efficacy between intravitreal conbercept injection and (or) macular grid pattern photocoagulation in treating macular edema secondary to non-ischemic branch retinal vein occlusion (BRVO). Methods Ninety eyes of 90 patients diagnosed as macular edema secondary to non-ischemic BRVO were enrolled in this study. Forty-eight patients (48 eyes) were male and 42 patients (42 eyes) were female. The average age was (51.25±12.24) years and the course was 5–17 days. All patients were given best corrected visual acuity (BCVA), intraocular pressure, slit lamp with preset lens, fluorescence fundus angiography (FFA) and optic coherent tomography (OCT) examination. The patients were divided into conbercept and laser group (group Ⅰ), laser group (group Ⅱ) and conbercept group (group Ⅲ), with 30 eyes in each group. The BCVA and central macular thickness (CMT) in the three groups at baseline were statistically no difference (F=0.072, 0.286;P=0.930, 0.752). Patients in group Ⅰ received intravitreal injection of 0.05 ml of 10.00 mg/ml conbercept solution (conbercept 0.5 mg), and macular grid pattern photocoagulation 3 days later. Group Ⅱ patients were given macular grid pattern photocoagulation. Times of injection between group Ⅰ and Ⅲ, laser energy between group Ⅰ and Ⅱ, changes of BCVA and CMT among 3 groups at 1 week, 1 month, 3 months and 6 months after treatment were compared. Results Patients in group Ⅰ and Ⅲ had received conbercept injections (1.20±0.41) and (2.23±1.04) times respectively, and 6 eyes (group Ⅰ) and 22 eyes (group Ⅲ) received 2-4 times re-injections. The difference of injection times between two groups was significant (P＜0.001). Patients in group Ⅱ had received photocoagulation (1.43±0.63) times, 9 eyes had received twice photocoagulation and 2 eyes had received 3 times of photocoagulation. The average laser energy was (96.05±2.34) μV in group Ⅰ and (117.41±6.85) μV in group Ⅱ, the difference was statistical significant (P=0.003). BCVA improved in all three groups at last follow-up. However, the final visual acuity in group Ⅰ and group Ⅲ were better than in group Ⅱ (t=4.607, –4.603;P＜0.001) and there is no statistical significant difference between group Ⅲ and group Ⅰ (t=–0.802,P=0.429). The mean CMT reduced in all three groups after treating for 1 week and 1 month, comparing that before treatment (t=–11.855, –10.620, –10.254;P＜0.001). There was no statistical difference of CMT between group Ⅰand Ⅲ at each follow up (t=0.404, 1.723, –1.819, –1.755;P=0.689, 0.096, 0.079, 0.900). CMT reduction in group Ⅰ was more than that in group Ⅱ at 1 week and 1 month after treatments (t=–4.621, –3.230;P＜0.001, 0.003). The CMT in group Ⅲ at 3 month after treatment had increased slightly comparing that at 1 month, but the difference was not statistically significant (t=1.995,P=0.056). All patients had no treatment-related complications, such as endophthalmitis, rubeosis iridis and retinal detachment. Conclusions Intravitreal conbercept injection combined with macular grid pattern photocoagulation is better than macular grid pattern photocoagulation alone in treating macular edema secondary to non-ischemic BRVO. Combined therapy also reduced injection times comparing to treatment using conbercept injection without laser photocoagulation.
ObjectiveTo assess the efficacy and safety of intravitreal aflibercept injection (IAI) compared with photodynamic therapy (PDT) in the treatment of Chinese patients with predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to neovascular age-related macular degeneration (nAMD).MethodsA randomized, double-blind, multi-center phase-3 clinical trial lasting for 52 weeks (from December 2011 to August 2014). Subjects were randomized in a 3:1 ratio to either IAI group or PDT-to-IAI group. Subjects in the IAI group received 2 mg IAI at baseline and at week 4, 8, 16, 24, 32, 40, 48, with sham injection at week 28, 36. Subjects in the PDT-to-IAI group were forced to receive PDT once at baseline and more time at week 12, 24 if PDT retreatment conditions were met. Sham injections were given in PDT-to-IAI group at baseline and at week 4, 8, 16 and 24, followed by 2 mg IAI at week 28, 32, 36, 40, 48. The primary outcome of efficacy were the change in mean Best Corrected Visual Acuity (BCVA) from baseline to week 28, and that of week 52. Safety evaluation included the percentage of subjects who suffered treatment emergent adverse events (TEAEs).ResultsAmong the 304 subjects enrolled, there were 228 and 76 cases in IAI group and PDT-to-IAI group respectively. At week 28, the changes of mean BCVA in IAI group, PDT-to-IAI group compared to baseline were +14.0, +3.9 letters, respectively. At week 52, the changes of mean BCVA in two groups were +15.2, +8.9 letters respectively with the difference of +6.2 letters (95%CI 2.6−9.9, P=0.000 9). At week 52, the mean foveal retinal thickness in the two groups decreased by −189.6, −170.0 μm, respectively. Subjects with the most BCVA increase in IAI group were those aged ＜65, and those with active CNV lesion area ＜50% of total lesion area. The most common TEAEs in IAI group and PDT-to-IAI group are macular fibrosis [11.8% (27/228), 6.6% (5/76)] and BCVA decline [6.6% (15/228), 21.1% (16/76)]. There were 3 cases of arterial thromboembolic events defined in the antiplatelet experimental collaboration group, but all were considered unrelated to interventions.ConclusionsThe efficacy of aflibercept is superior to that of PDT in nAMD patients in China. The therapeutic effect of aflibercept persisted to week 52 in all subjects. The rate of adverse events was consistent with the safety data of aflibercept known before.
ObjectiveTo compare the efficacy of photodynamic therapy (PDT) alone or in combined with ranibizumab versus ranibizumab monotherapy (intravitreal injection, IVR) in patients with polypoidal choroidal vasculopathy (PCV). Methods80 eyes of 72 patients with PCV were enrolled into this retrospective and comparative study according to their therapeutic plan. 30 eyes of 28 patients, 28 eyes of 30 patients and 22 eyes of 21 patients were divided into PDT group, ranibizumab 0.5 mg group (IVR group) or the combination group, respectively. The patients with PCV were diagnosed according to clinical symptoms, optical coherence tomography (OCT) and fluorescent indocyanine green angiography (ICGA). The baseline best-corrected visual acuity (BCVA) before treatment was more than 0.05, and there was no retinal fibrosis and scar for all patients. There was no statistical difference of age (F=0.187), gender (χ2=0.423), average BCVA (F=1.120) and central retinal thickness (CRT) (F=0.431) among three groups (P > 0.05). They had not received any treatment before. Patients received verteporfin PDT in PDT group, 3 consecutive monthly IVRs starting day 1 in IVR group, and 3 IVRs after 3 days, 1 month, 2 months of PDT starting day 1 in combination group. Re-treatment was considered 3 months later if the follow up shown no changes in fundus photography, OCT and ICGA. The average follow-up time was 19 months. BCVA at baseline and follow-up visit at 1, 3, 6, 12 months was measured, and the proportion of patients with ICGA-assessed complete regression of polyps at month 6 was recorded as primary outcome. The CRT was measured at baseline and 6 months as secondary outcome. ResultsThere were significant difference of BCVA at 1, 3, 6 and 12 months among three groups(F=5.480, 5.249, 3.222, 4.711; P < 0.05). The average BCVA was significantly better at 1, 3, 6, 12 month than that at baseline(t=-6.632, -4.127, -3.904, -4.494; P < 0.05) in combination group, and was significantly better at 3, 6, 12 months than that at baseline (t=-5.636, -3.039, -3.833; P < 0.05) in IVR group. However there was no significant difference of the average BCVA in PDT group between follow-up at 1, 3, 6, l 2 months and baseline (t=1.973, 0.102, -0.100, -0.761; P > 0.05). The proportion of patients with complete regression of polyps at 6 months was higher in PDT (76.7%) or combination group (68.2%) than IVR group (35.7%) (χ2=0.003, 0.025; P < 0.05). There was no significant difference of CRT among 3 groups at baseline (P=0.651). The mean CRT decreased in all 3 treatment groups over 6 months (t=5.120, 3.635, 5.253; P < 0.05), but there was no significant difference of CRT among 3 groups (F=1.293, P > 0.05). ConclusionsThree therapies could effectively decrease CRT. IVR or IVR combined with PDT are both more effective than PDT therapy to improve vision of PCV patients. PDT or PDT combined with IVR was superior to IVR pnly in achieving complete regression of polyps in 6 months in PCV patients.
Objective To observe the therapeutic effect of ultrasonic microbubble combined with bevacizumab (Avastin) on choroidal neovascularization induced by photocoagulation in rabbits.Methods CNV was induced by photocoagulation with argon laser in 30 rabbits (60 eyes).All of the rabbits underwent fundus fluorecein angiography (FFA) 21 days after photocoagulation; 6-8 hours later, 3 rabbits were randomly chosen to be executed to having the immunohistochemical examination.Twenty one days after photocoagulation, 27 rabbits were divided randomly into 3 groups: bevacizumb, ultrasonic microbubble + bevacizumb,and control group; each group has 9 rabbits (18 eyes).The rabbits in control group had no interference treatment; while the rats in bevacizumb and ultrasonic microbubble + bevacizumb group underwent injection with bevacizumb or ultrasonic microbubble + bevacizumb respectively.FFA was performed on all of the rabbits 7,14,and 28 days after photocoagulation to observe the inhibition of CNV; immunofluorecence and Western blot were used to detect the expression of VEGF in retina and choroid.Twentyeight days is the time point to determine the therapeutic efficacy. The expression of VEGF and the results of FFA were the sdandards of the judgement of therapeutic efficacy.Results Proliferaion of CNV to the retinal inner layer and the obvious leakage of fluoresein in the photocoagulation area indicated that the model of CNV was set up successfully. Twenty eight days after injection,obvious fluorescent leakage was found in the control group, and the average fluorescent leakage in bevacizumab group differed much from the control group（t=16.2952，Plt;0.05）; while the difference between ultrasonic microbubble + bevacizumb group and bevacizumab group was also significant (t=4.7955，Plt;0.05) . At the same time point, the expression of VEGF in bevacizumab group detected by immunofluorecent assay and Western blot differed much from the control group (t=7.0327，9.2596；Plt;0.05),and the difference of VEGF between ultrasonic microbubble + bevacizumb group and bevacizumab group was significant（t=2.9724,17.1937；Plt;0.05）. this experiment show that ultrasound combined bevacizumab intravitreal injection of the therapeutic effect of CNV superior to other groups(Plt;0.01).Conclusion Ultrasound microbubble combined with bevacizumab injection may improve the therapeutic effect on CNV by inhibiting the expression of VEGF.
ObjectiveTo observe the clinical effect of intravitreal ranibizumab (IVR) combined with vitrectomy in treating proliferative diabetic retinopathy (PDR). MethodsThis is a prospective non-randomized controlled clinical study. A total of 62 patients (70 eyes) who underwent vitrectomy for PDR were enrolled and divided into IVR group (30 patients, 34 eyes) and control group (32 patients, 36 eyes).IVR group patients received an intravitreal injection of 0.05 ml ranibizumab solution (10 mg/ml) 3 or 5 days before surgery. The follow-up time was 3 to 18 months with an average of (4.5±1.8) months. The surgical time, intraoperative bleeding, iatrogenic retinal breaks, use of silicone oil, the best corrected visual acuity (BCVA) and the incidence of postoperative complications were comparatively analyzed. ResultsThe difference of mean surgical time (t=6.136) and the number of endodiathermy during vitrectomy (t=6.128) between IVR group and control group was statistically significant (P=0.000, 0.036). The number of iatrogenic retinal break in IVR group is 8.8% and control group is 27.8%, the difference was statistically significant (χ2=4.154, P=0.032). Use of silicone oil of IVR group is 14.7% and control group is 38.9%, the difference was statistically significant (χ2=5.171, P=0.023). The incidence of postoperative vitreous hemorrhage in 3 month after surgery was 11.8% and 30.6% respectively in IVR group and control group. The differences were statistically significant (χ2=3.932, P=0.047). The 6 month postoperative mean BCVA of IVR group and control group have all improved than their preoperative BCVA, the difference was statistically significant (t=4.414, 8.234; P=0.000).But there was no difference between the mean postoperative BCVA of two groups (t=0.111, P=0.190). There was no topical and systemic adverse reactions associated with the drug after injection in IVR group. ConclusionsMicroincision vitreoretinal surgery assisted by IVR for PDR shorten surgical time, reduces the intraoperative bleeding and iatrogenic retinal breaks, reduces the use of silicon oil and the postoperative recurrent vitreous hemorrhage. But there was no significant relationship between vision improvement and IVR.
ObjectiveTo assess the clinical efficacy of vitrectomy with intravitreal ranibizumab (IVR) at different injection time for proliferative diabeticretinopathy (PDR). MethodsThis was a prospective, comparative, and randomized study. Ninety-seven eyes of 97 patients were enrolled and randomly assigned to three different treatment groups: 30 eyes (30 patients) in the preoperative IVR group, 32 eyes (32 patients) in the intraoperative IVR group and 35 eyes (35 patients) in the no IVR injection group. The best corrected visual acuity (BCVA) (F=0.18) and the grading of vitreous hemorrhage (χ2=1.39) before surgery did not differ significantly among the 3 groups, respectively (P > 0.05). All eyes enrolled underwent conventional 23-gauge pars plana vitrectomy (PPV). The preoperative IVR group received intravitreal 0.5 mg/0.05 ml ranibizumab injection 3 to 7 days before PPV, intraoperative IVR group received intravitreal 0.5 mg/0.05 ml ranibizumab injection at the end of PPV and non-drug injection group received PPV only. Postoperative BCVA, fundus color photography, optical coherence tomography examination was performed in all eyes at 1 week and 1, 3, 6, 9, 12 months after surgery. Early RVH was defined as RVH occurred within 1 week to 1 month postoperatively; while late RVH was defined as RVH occurred 1 month later after the operation. ResultsThe mean BCVA were all improved among the 3 groups compared with the preoperative vision at 1 month after operation. At the beginning of 3 months after surgery, the average BCVA of the preoperative injection group and the intraoperative injection group tended to stable; while 3 eyes in the non-drug injection group began to decreased. There was no significant difference in average BCVA at 1, 3 and 12 months of follow-up periods among the 3 groups (F=1.42, 1.17, 0.26; P > 0.05). The incidences of early RVH were 16.7%, 9.4%, 28.6% in the preoperative injection group, intraoperative injection group, and non-drug injection group, respectively (χ2=5.12, P < 0.05). The incidence of early RVH in the intraoperative injection group reduced compared to preoperative injection group and non-drug injection group (χ2=4.04, 4.93; P < 0.05). The incidences of late RVH were 13.3%, 9.4%, 14.3% in preoperative injection group, intraoperative injection group, and non-drug injection group, respectively (χ2=0.47, P > 0.05). The average centeral foveal thickness (CFT) decreased among the 3 groups in different degrees at 1 month when compared with that of 1 week after operation and the decreasing was statistically significant (F=59.50, P < 0.05). A subgroup pairwise analysis showed no significant difference of decreasing CFT in preoperative injection group compared with that of intraoperative injection group (t=0.23, P > 0.05). The average CFT of the 3 groups had different degrees of thickening at 3, 6, 9, 12 months after surgery, and the increasingof CFT among the 3 groups were not differ significantly (F=2.92, 2.86, 3.07, 3.12; P > 0.05). ConclusionsThe adjunctive use of IVR can reduce the incidence of early postoperative RVH in vitrectomy for PDR, decrease in macular thickness and obtain favorable visual recovery. The effect of preoperative IVR injection was slightly better than that of the intraoperative IVR injection.
Objective To observe the efficacy of intravitreal injection of ranibizumab (IVR) for different patterns of optical coherence tomography (OCT) of diabetic macular edema and the relationship between integrity of ellipsoidal zone and visual acuity outcomes. Methods Eighty-five IVR treated eyes were enrolled. The examination of BCVA was according to Early Treatment Diabetic Retinopathy Study, and the results were recorded as logarithm of the minimum angle of resolution (logMAR). Frequency-domain OCT was used to measure the central foveal thickness (CFT) and the integrity of ellipsoidal zone. All eyes were classified as diffuse macular edema (DRT group, 31 eyes), cystoid macular edema (CME group, 29 eyes), and serous retinal detachment (SRD group, 25 eyes). All the patients were treated with intravitreal injection of 0.05 ml (0.5 mg) ranibizumab. The mean follow-up time was (9.21+3.56) months after IVR treatment. The changes of BCVA and CFT in 3 groups were compared and analyzed after 3, 6 and 12 months. According to visual acuity at different ranges, the relationship between integrity of ellipsoidal zone and BCVA was analyzed. Results Compared with the average logMAR BCVA before treatment, except for 12 months after treatment in group SRD (t=2.104,P=0.053), the average logMAR BCVA after IVR at 3 months, 6 months and 12 months improved in DRT group (t=7.847, 6.771, 6.426;P=0.000, 0.000, 0.000), CME group (t=8.560, 6.680, 5.082;P=0.000, 0.000, 0.000) and SRD group (t=5.161, 3.968, 2.104;P=0.000, 0.001, 0.053). The average logMAR BCVA of the DRT group was lesser than that in CME and SRD group after 12 months treatment (t=–2.043, –3.434;P=0.030, 0.001). The average CFT after IVR at 3 months, 6 months and 12 months reduced significantly in DRT group (t=12.746, 10.687, 9.425;P=0.000, 0.000, 0.000), CME group (t=13.400, 11.460, 10.169;P=0.000, 0.000, 0.000), and SRD group (t=11.755, 10.100, 9.173;P=0.000, 0.000, 0.000). After 12 months of treatment, the average CFT of the SRD group was thicker than that in DRT group and CME group (t=–3.251, –1.227;P=0.003, 0.025); there was significant difference in the integrity of ellipsoidal zone among 3 groups (χ2=1.267,P=0.531). The results showed that there were significant differences in the integrity of ellipsoidal zone with different ranges of BCVA before and after 12 months treatment (χ2=20.145, 41.035;P=0.000, 0.000). Conclusions IVR could significantly improve the visual acuity of different patterns of DME, reduced the CFT, and had the best efficacy in the DRT group. There was relationship between the integrity of ellipsoidal zone and the visual acuity outcomes.