Anti-vascular endothelial growth factor (VEGF) drugs, including monoclonal antibodies (such as bevacizumab and ranibizumab) and fusion protein agents (such as aflibercept and conbercept) have been clinically proven to be effective to treat exudative age-related macular degeneration AMD). However, there are still some patients do not or poorly respond to the initial anti-VEGF agents, usually after several injections, ophthalmologists may switch to another anti-VEGF agent. In general, switching of anti-VEGF agent is considered for recurrent AMD, AMD resistance to anti-VEGF treatments. Current switching protocols include the replacement of monoclonal antibodies with fusion protein agents, the replacement of fusion protein agents with monoclonal antibodies, the substitution of one monoclonal antibody with another one, and the replacement of monoclonal antibodies with fusion protein agents and switching back with monoclonal antibodies. However, current researches on the switching of anti-VEGF drugs for exudative AMD are mostly retrospective and single-arm studies, and there are some differences in the results of different studies. Therefore, for patients with exudative AMD who do not respond to or respond poorly to anti-VEGF drugs, the efficacy of switching of anti-VEGF drugs is uncertain right now. Switching of anti-VEGF agents may improve the retinal anatomical outcome of the affected eye but may not necessarily improve visual acuity. Thus it is an option in the clinical practice to treat AMD. To determine the benefits of above mentioned switching regimens, randomized controlled clinical trials with large sample number and long study period will be needed.
Diabetic macular edema (DME) is a common ocular complication of diabetes patients. It mainly involve macular which is closely related with visual function, thus DME is one of the major reasons causing visual impairment or blindness for diabetes patients. How to reduce the visual damage of DME is always a big challenge in the ophthalmic practice. In the past three decades, there are tremendous developments in DME treatments, from laser photocoagulation, antiinflammation drugs to antivascular endothelial growth factor therapy. However, the mechanism of DME development is not yet completely clear; every existing treatment has its own advantages and weaknesses. Therefore DME treatment still challenges us to explore further to reduce the DME damages.
ObjectiveTo observe the clinical efficacy of intravitreal Conbercept on idiopathic choroidal neovascularization (ICNV). MethodsThis is an open and prospective study without control trial. Twelve eyes from 11 patients (7 females and 4 males) with ICNV diagnosed by best corrected visual acuity (BCVA), non-contact tonometer, ophthalmoscope, fundus photography, optical coherence tomography (OCT) and fundus fluorescein angiography (FFA) were enrolled in this study. All affected eyes were treated with intravitreal Conbercept 0.05 ml (10 mg/ml) and received an average of (1.91±1.04) injections. The initial average letters of Early Treatment Diabetic Retinopathy Study (ETDRS) chart acuity were 61.73±14.58, range from 25 to 77. The patients were followed up for 6 to 9 months.The initial average central retinal thickness (CRT) was (330.73±47.79)μm, range from 290 to 467 μm. Best-corrected visual acuity (BCVA), OCT and ophthalmoscope examination were assessed monthly. ResultsDuring the 1, 3, 6 months after treatment, themean BCVA were all improved with statistically significant difference (t=2.68, 3.80, 3.65; P < 0.05). At 1 month later after treatment, the mean BCVA was obviously improved in 1 eye (9.09%), improved in 8 eyes (72.73%), stable in 1 eye (9.09%), decreased in 1 eye (9.09%). At 6 month later after treatment, the mean BCVA was obviously improved in 3 eyes (27.27%), improved in 6 eyes (54.55%), stable in 1 eye (9.09%), decreased in 1 eye (9.09%).During the 1, 3, 6 months after treatment, the mean CRT were all decreased with statistically significant difference(t=2.44, 3.78, 4.12; P < 0.05).At latest follow up, the leakage in macula lutea disappeared in 6 eyes(58.33%), decreased in 11 eyes (25%)and increased in 3 eyes (16.67%). There were no systemic or ocular serious side effects during the follow up. ConclusionIntravitreal Conbercept for ICNV showed CNV regression, retinal thickness reduction, visual acuity improvement and safety.
Objective To evaluate the effectiveness of repeated intravitreal conbercept injection in patients with macular edema (ME) of retinal vein occlusion (RVO), guided by optic coherence tomography (OCT). Methods It is a retrospective case study. Forty patients (40 eyes) diagnosed as ME secondary to RVO were enrolled in this study. There were 19 males (19 eyes) and 21 females (21 eyes), with the mean age of (53.58±13.19) years and the mean course of 1.5 months. The best corrected visual acuity (BCVA), indirect ophthalmoscopy, fundus fluorescein angiography (FFA) and OCT were performed. The mean baseline of BCVA, central macular thickness (CMT) were 0.25±0.18 and (509.48±170.13) μm respectively. All the patients were treated with 10.00 mg/ml conbercept 0.05 ml (including conbercept 0.5 mg). Follow-up of these patients was 1 to 6 months after treatments, the BCVA, fundus manifestations, OCT were retrospectively observed by every month, the FFA was retrospectively observed by every 3 months. When there was retinal edema or CMT ≥50 μm by OCT during follow-up, those patients were retreated with intravitreal conbercept injection. The changes of the BCVA, CMT were evaluated before and after treatment. Meanwhile, complications in eyes related to medicine and treatment methods were evaluated too. Results At the 6 months, the BCVA was improved (increase≥2 lines) in 25 eyes (62.50%), stabilized (±1 line) in 13 eyes (32.50%) and decreased 2 lines in 2 eyes (5.00%). Retinal hemorrhage and exudates were absorbed in most patients. FFA showed no fluorescein leakage in 11 eyes (27.50%), minor fluorescein leakage in 26 eyes (65.00%), and retinal capillary non-perfusion in 3 eyes (7.50%). OCT showed absorption of the subretinal fluid. The mean CMT were (235.20±100.44) μm at 6 months. Intravitreal injection of conbercept was applied for 4 times in 8 eyes (20.00%), 3 times for 18 eyes (45.00%), and 2 times for 14 eyes (35.00%). The mean number of intravitreal injection was 2.85 times. There were no ocular or systemic adverse events observed in all patients. Conclusion Intravitreal conbercept injection is an efficacy and safe treatment for the patients with ME of RVO guided by OCT. It can stabilize and improve the visual acuity.
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 investigate the effect of photodynamic therapy (PDT) combined with intravitreal bevacizumab on wet age-related macular degeneration (AMD). Methods In this retrospective study, 34 eyes (28 cases) diagnosed with wet AMD received PDT combined intravitreal injection of bevacizumab, including 25 eyes with classic CNV and 9 eyes with minimally classic CNV by fluorescein angiography; On optical coherence tomography (OCT), 23 eyes showed intraretinal fluid (IRF) and 11 eyes presented subretinal fluid (SRF). After signing informed consent, all patients underwent initial standard PDT followed by intravitreal bevacizumab (1.25 mg) within succeeding 3 to 7 days. Best corrected visual acuity (BCVA) and OCT with routine eye examinations were evaluated monthly. Additional bevacizumab (1.25 mg) was injected intravitreally if new or increasing fluid appreciated on OCT, or BCVA lowered more than 5 letters even with stabilized fluid. Injection was discontinued if no fluid was showed on OCT (quot;dry macularquot;), or BCVA was stabilized even with fluid after two consecutive injections. BCVA and central retinal thickness (CRT) were analyzed and compared between baseline and 6 month follow-up. The correlation between parameters such as baseline BCVA, greatest linear dimension (GLD), type of CNV, SRF or IRF and posttreatment BCVA will be analyzed. The injection number of bevacizumab and complications were recorded. Results Compared to baseline, BCVA improved (9.4plusmn;10.2) letters and reach 44.9plusmn;21.3 letters (t=5.438，P＜0.01) and CRT decreased (184.6plusmn;214.6) mu;m (t=4.810，P＜0.01) at 6 month visit. The average of injection number was 1.9plusmn;0.9 (including initial injection of combination therapy). With multiple lineal regression analysis, only baseline BCVA correlated to posttreatment BCVA at 6 month visit (r=0.802.P＜0.01). The type of CNV, GLD, SRF or IRF on OCT and CRT at baseline were not associated to post-treatment BCVA (r=0.053, -0.183, 0.139 and 0.053, respectively.P＞0.05). BCVA of eyes with SRF (14.7 letters) increased more than eyes with IRF (6.9 letters) on OCT (t=-2.207，P=0.035). The change of BCVA after treatment (t=-0.076), change of CRT (t=-1.028) and number of injections (Z=-1.505) were not different between classic CNV and minimally classic CNV (P＞0.05). The change of CRT (t=-0.020) and number of injections (Z=-0.237) did not present difference between SRF and IRF (P＞0.05). The change of BCVA (t=1.159) and number of injections (Z=-1.194) were not correlated to whether residual fluid or not at 6 month visit (P＞0.05). No severe complications were noticed during follow-up.Conclusion For wet AMD patients, PDT combined intravitreal bevacizumab could improve visual acuity, reduce retinal thickness and control CNV progress in a short-term.
Objective To observe the efficacy and safety of intravitreal injection of Ranibizumab(Lucentis) on exudative age－related macular degeneration (AMD). Methods To analyze retrospectively the clinical data of 56 patients with exudative AMD, which was diagnosed by examination of ETDRS charts, color fundus photograph, fluorescein angiography(FFA) or indocyanine green angiography(ICGA) and optical coherence tomography(OCT), were underwent intravitreal injection Lucentis 0.5 mg. Before the treatment, the ETDRS charts letter of 56 eyes was 25.1; choroidal neovascularization(CNA) was leaky which examined by FFA and ICGA; the average thickness of retina was 303.45 mu;m. Ranibizumab injection therapeutic times were 2.8, the average therapeutic times were 3.1. Follow－up time was 6－12 months (mean 8.7 months). Visual acuity (ETDRS charts letter), retinal thickness, leakage of CNV and operative complications before and after the treatment were analyzed. Results At the end of the follow－up period, the mean letter of ETDRS charts was 38.5, increased 13.4 letters (P＜0.01), the ETDRS charts improved 15 or more letters in 22 eyes (39.3%), decreased more than 15 letters in 2 eyes (3.6%); the foveal thickness on OCT images were 303.45 mu;m before treatment and 191.35 mu;m a fter treatment, decreased significantly (P＜0.00); FFA and/ or ICGA showed CNV complete closure in 12 eyes (21.4%), partial closure in 33 eyes (58.9%), no change in 9 eyes (16.1%) and new CNV in 1 eye (1.8%); Slight complications after operation disappeared during one week. Conclusion Intravitreal injection of Ranibizumab for exudative AMD was well tolerated, with an improvement in VA, FFA or ICGA , and OCT. (Chin J Ocul Fundus Dis,2008,24:160-163)
ObjectiveTo compare the one year efficacy of intravitreal injection with ranibizumb for macular edema (ME) secondary to ischemic and non-ischemic central retinal vein occlusion (CRVO).MethodsA total of 88 patients (88 eyes) with ME secondary to CRVO were enrolled in this retrospective study. The best corrected visual acuity (BCVA) was detected by the Early Treatment Diabetic Retinopathy Study Chart. The optical coherence tomography was used to measure the foveal retinal thickness (CRT) and macular edema volume. The patients were divided into non-ischemic group and ischemic group, 44 eyes of 44 patients in each group. There was no significant differences in age (t=0.650, P=0.517) and gender (χ2=0.436, P=0.509) between the two groups. Compared with the ischemic group, the CRT was significantly decreased in the non-ischemic group (t=−2.291, P=0.024), and the edema volume in the macular area was significantly reduced (t=−2.342, P=0.022). All eyes were treated with continuous intravitreal injection of ranibizumab three times, and repeated injections were performed as needed. The patients without obvious ME regression after treatment were combined with triamcinolone acetonide injection. The patients with peripheral retinal non-perfusion area were combined with peripheral retinal laser photocoagulation. The follow-up was 1 year. The number of injections was counted. The changes of BCVA, CRT and edema volume in the macular area were compared between the two groups.ResultsDuring the 1-year follow-up period, 88 eyes were injected 1 to 10 times, with the mean of 4.51±2.33. The number of injections in the ischemic group and non-ischemic group were 4.55±1.59 and 4.48±2.91, respectively. There was no significant difference in the average number of injections between the two groups (t=0.136, P=0.892). The number of acetonide injections and laser treatment in the ischemic group was significantly higher than that in the non-ischemic group (t=3.729, 9.512; P＜0.001). At the last follow-up, compared with the ischemic group, the BCVA was increased (t=8.128), the CRT was decreased (t=−7.029) and the edema volume in the macular area was decreased (t=−7.213) in the non-ischemic group (P＜0.001).ConclusionCompared with ME secondary to ischemic CRVO, intravitreal injection of ranibizumab for ME secondary to non-ischemic CRVO has the better outcome of vision improvement and edema regression as well as less frequent of acetonide injections and laser treatment.
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.
Objective To evaluate the efficacy and safety of photodynamic therapy (PDT) combined with intravitreal injection of bevacizumab for choroidal neovas cularization (CNV) caused by age-related macular degeneration (AMD). Methods A total of 21 eyes of 21 patients with AMD, which was diagnosed by examination of visual acuity, intraocular pressure, ocular fundus, fundus color photography, fundus fluorescein angiography(FFA), indocyanine green angiography(ICGA)and optic coherence tomography(OCT), were underwent PDT combined with intravitreal injection of Bevacizumab. The patients, 15 males (15 eyes) and 6 females (6 eyes), aged from 56 to 78 years, with the average of 68.6 years. The best corrected visual acuity：counting fingers/10cm0.9, logMAR was 1.04 plusmn; 0.41.CNV located in below or side central fovea of macula. There was obvious leakage of fluorescein which examined by FFA and ICGA. The average of retinal thickness of macular foveal was （258.91 plusmn; 78.66）mu;m. The treatment method of PDT has to according to the way of PDT for TAP and Verteporfin PDT for VIP. Intravitreal infection with 1.5mg bevacizumab was performed after three days under surface anesthesia. Follow-up time was 1, 3, 6, 12 months after the treatment. Results At last visit, the best-corrected visual acuity：counting fingers/10 cm 1.5, logMAR was 1.04plusmn;0.41, and the differences are statistically significant compared with before. The BCVA improved four or more lines in 6 eyes (28.57%), improved two to four lines in 9 eyes (42.86%), stabilized (plusmn;1 line or no change) in 6 eyes (28.57%) and decreased in none. The average intraocular pressure was （15.20plusmn;2.41）mmHg after surgery, and the differences was not statistically significant compared with before（P＞0.05）. FFA and ICGA showed CNV complete closure in 13 eyes (61.90 %), partial closure in 8 eyes (38.10%). The average of retinal thickness of mac ular foveal was（127.38plusmn;20.14） mu;m (P＜0.01). Conclusion Combining treatment with PDT and intravitreal injection of Bevacizumab is safe and effective for CNV which caused by AMD. It has significant improvement in BCVA, leakage of CNV and retinal edema. (Chin J Ocul Fundus Dis,2008,24:164-167)