Ranibizumab Research Articles

The clinical study on intravitreous injection of ranibizumab for aggressive posterior retinopathy of prematurity

To observe the retinal vascular development and changes on aggressive posterior retinopathy of prematurity (AP-ROP) by intravitreal ranibizumab, evaluate the therapeutic effect, and provide the basis for clinical treatment. The total of 38 eyes of 19 premature infants who were diagnosed as AP-ROP from January 2012 to October 2013 in our hospital were performed intravitreal injection of ranibizumab (0.04 ml). It was observed about the regression of plus diseases, ridges, neovascularization on the ridge and the development of peripheral retinal vessel. Laser photocoagulation were performed for 14 eyes of 7 cases whose plus diseases, ridges and neovascularization on the ridge didn't regress completely after intralvitreal injection of ranibizumab. All infants were found retinopathy regressed and retinal vessels continued to develop peripherally to some degree. Of all infants, 24 eyes of 12 infants were found complete regression of retinopathy, resolution of neovascularization and bleeding and that retinal vessels continued to develop to ora serrata or scarification of peripheral retinopathy. Fourteen eyes of 7 infants were found retinopathy didn't regressed completely and regressed completely after combing intravitreal ranibizumab injection. All 19 infants didn't occure infection, ocular or systemic complications. The efficacy of intravitreal injection of ranibizumab is good for AP-ROP. It can made ridge, neovascularization on the ridge and plus disease regress, as well as let the retinal vessel continue development. Infants with no regressed retinopathy may need combined laser photocoagulation.

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Ranibizumab

The effectiveness and safety evaluation of anti-VEGF drugs on the treatment of corneal neovascularization

The studies and clinical applications of Ranibizumab and Bevacizumab which are new anti-VEGF drugs have made significant progression on the treatment of corneal neovascularization. The effectiveness and safety of Ranibizumab compared with Bevacizumab has been the focus of the debate for scholars nowadays. Some experiments showed that the effect of Bevacizumab was better than Ranibizumab. But combined with our experiments, Ranibizumab represented the advantages of shorter effect time, stronger affinity with VEGF-A, better tolerance with repeated injections etc. So we believed that the adequate doses of ranibizumab had better effects. Its clinical application should be paid much attention.

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Ranibizumab

Ranibizumab

Ranibizumab

Comparative analysis of the development of collateral vessels in macular edema due to branch retinal vein occlusion following grid laser or ranibizumab treatment.

PurposeTo evaluate the differences in the development of collateral vessels in patients with macular edema due to branch retinal vein occlusion (BRVO) after treatment with either grid laser or ranibizumab (RNB).MethodsComparative study including patients with macular edema due to acute BRVO and best-corrected visual acuity (BCVA) between 20/40 and 20/200. The sample was divided into two groups according to the treatment applied: laser group, including eyes treated with Argon laser when retinal hemorrhages were sufficiently absorbed to perform the treatment, and RNB group, including patients treated initially with one monthly intravitreal injection for a period of 3 months of RNB and more injections according to need thereafter. Before treatment patients in both groups, received a complete ophthalmic examination, including BCVA, fundus examination, optical coherence tomography, fundus color photography, and fundus fluorescein angiography (FA). This same protocol of examination was repeated in every visit after treatment, except FA that was only repeated every 3 months. The detection of the collateral vessels was done by two experienced examiners based on the analysis of the early phase of the FA. If there was a discrepancy in their judgment, the criterion of a third examiner evaluating the FA was considered.ResultsMean baseline BCVA was 0.86±0.26 and 0.82±0.25 (logMAR [logarithm of the minimum angle of resolution]) in the RNB and laser groups, respectively (P=0.83). At the end of the follow-up, mean BCVA was 0.38±0.18 and 0.64±0.33 (logMAR) in the RNB and laser groups, respectively. The difference in the final BCVA between both groups was statistically significant (P=0.002). Collaterals developed in both groups; 66.67% of patients (14 out of 21 patients) developed collaterals at a mean time of 6.14±2.60 months after diagnosis in the RNB group, and 68.18% (16 out of 22 patients) developed collaterals in the laser group at a mean time of 6.2±1.97 months after diagnosis. No statistically significant differences between groups were found in the number of cases developing collateral vessels (P=1.00) as well as in the time required for such development (P=0.947).ConclusionThe use of RNB for the treatment of macular edema due to BRVO does not seem to alter the development of collateral vessels. Future studies with larger samples are required to confirm these outcomes.

Tachyphylaxis during ranibizumab treatment of exudative age-related macular degeneration.

Dear Editor,We are intestigators from Turkey primarily studying exudative age-related macular degeneration(AMD).Here we present the results of our retrospective clinical study on tachyphylaxis development during the treatment of exudative AMD with ranibizumab,which,we believe,will form a basis for further prospective studies to predict the drug response in anti-vascular endothelial growth factor

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Ranibizumab

Comparison of efficacy of different methods for diabetic macular edema

Objective To evaluate the clinical efficacy of intravitreal injection of ranibizumab combined with macular grid photocoagulation for diabetic macular edema (DME). Methods Totally 60 eyes of 60 patients with DME were randomly divided into three groups with 20 cases in each group. Patients in group A received intravitreal ranibizumab injection every 4 weeks for 3 months and macular grid photocoagulation was performed 1 week later. Patients in group B received intravitreal injection of ranibizumab with same dose and same frequency without macular grid photocoagulation. Patients in group C received intravitreal injection of ranibizumab only once. At 1, 3 and 6 months follow-up after the first injection, the changes of best corrected visual acuity (BCVA) and center macular thickness (CMT) between 3 groups were compared. Results In group A, the BCVA and CMT after injection were satisfactory and steady during follow-up (all P 0.05). The CMT had no statistically significant difference between pre-operation and 6 months after the treatment (P>0.05). Conclusion Successive intravitreal injection of ranibizumab combined with macular grid photocoagulation can effectively improve visual acuity and decrease central macula thickness for patients with DME. But the stability at postoperative 6 months of the combined treatment group is better than successive intravitreal injection therapy group. The successive intravitreal injection method with or without macular grid photocoagulation is better than monoinjection therapy. Key words: Diabetic retinopathy; Macular edema; Ranibizumab; Grid photocoagulation

Clinical observation of ranibizumab intravitreal injections for the treatment of age-related macular degeneration

Objective To observe the clinical efficacy of ranibizumab intravitreal injections for the treatment of exudative age-related macular degeneration (AMD). Methods Seventy-one eyes of 60 patients with active exudative AMD in the First Affiliated Hospital of Zhengzhou University from June 2013 to June 2014 were collected. The treatment was performed according to the following schedule: intravitreal injection of 0.5 mg ranibizumab once a month for 3 months. Central macula thickness (CFT) was measured by optical coherence tomography (OCT) after the third injection and further injections were based on the measuring process. The best corrected visual acuity (BCVA), and the fundus situation at the third month and the sixth month after this treatment were analysed. Results The effective rate of this treatment was 91.55%. The differences in BCVA and the CFT between pre-treatment and the third month or the sixth month after this treatment were both statistically significant (P=0.002, P=0.001). Conclusion Ranibizumab intravitreal injections for exudative AMD is an effective and safe method. Key words: Age-related macular degeneration, exudative; Ranibizumab; Intavitreal injection; Efficacy

The effect of microincision vitrectomy and intravitreal injection of ranibizumab in the treatment of proliferative diabetic retinopathy

Objective To observe the effect of microincision vitrectomy assisted with intravitreaI injection of ranibizumab (IVR) in proliferative diabetic retinopathy (PDR) treatment. Methods This is a prospective, randomized, and comparative case series study. A total of 92 patients (92 eyes) with PDR were recruited to have microincision vitrectomy with (combined group) or without (PPV group) IVR. There are 48 eyes in the combined group and 44 eyes in the PPV group. The average operation time, iatrogenic breaks, the use of tamponade and electric coagulation, postoperative bleeding and best corrected visual acuity were comparatively analyzed among the two groups.The mean follow-up was (14.3±5.2) months. Results The average operation time was (59.4±18.5) min in the combined group and (74.6±16.2) min in the PPV group. The rate of silicone oil tamponade (χ2=4.619), inert gas tamponade (χ2=4.290), electric coagulation (χ2=8.039) and iatrogenic breaks (χ2=4.330) in the combined group were significantly decreased compared with PPV group(P<0.05). The mean logMAR BCVA was 0.83±0.44 in the combined group and 1.37±0.53 in the PPV group, which significantly improved from preoperatively (t=3.257, 3.012; P<0.05). The rate of BCVA improvement in the combined group was significantly higher than that in the PPV group (t=2.972, P<0.05). The incidence of the recurrent vitreous hemorrhage was 2.1% in the combined group and 9.1% in the PPV group (χ2=6.741, P<0.05). There was no severe complication associated with surgery, such as choroidal detachment, retinal detachment and endophthalmitis. Conclusion IVR before the microincision vitrectomy can shorten the operation time, reduce the use of electric coagulation and intraocular tamponade, and improve visual acuity for PDR patients. Key words: Diabetic retinopathy/surgery; Diabetic retinopathy/drug therapy; Antibodies, monoclonal/therapeutic use; Angiostatins/therapeutic use; Vitreoretinal surgery

A retrospective analysis on the incidence and treatment outcomes of retinopathy of prematurity among extremely preterm infants

Objective To analyze the incidence of retinopathy of prematurity(ROP)among extremely preterm infants, and to evaluate the treatment methods and effects among those with severe ROP. Methods A retrospective analysis was performed to analyze incidence of ROP in 96 cases of extremely preterm infants who were born at a gestational age of <28 weeks and survived beyond a postmenstrual age of at least 1 year from Apr 2006 to Oct 2013, and to analyze the treatment outcomes of photocoagulation and ranibizumab intravitreal injection among the infants with severe ROP. Results Fifty-six of 96 cases(58.33%)grew into ROP finally and 21 cases(21.88%)grew into severe ROP, 2 cases(2.08%)grew into aggressive posterior ROP.Fifteen cases with severe ROP were treated with laser photocoagulation.Four cases with severe ROP were received ranibizumab intravitreal injection prior to photocoagulation.Two cases with severe ROP were only treated with ranibizumab intravitreal injection.The eyesight of 96 patients(100%)in this study were all preserved. Conclusion ROP screening should focus on extremely preterm infants because of higher incidence of ROP and severe ROP among them.The infants with severe ROP should be treated with laser photocoagulation in time.The infants in critical condition or with aggressive posterior ROP can be treated with ranibizumab injection. Key words: Extremely preterm infant; Retinopathy of prematurity; Photocoagulopathy; Antibody of vascular endothelial growth factors

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Ranibizumab

Ranibizumab: Phase III clinical trial results.

Ranibizumab therapy is the first treatment for neovascular AMD to improve vision for most patients. The benefits apply to all angiographic subtypes of neovascular AMD and across all lesion sizes. Although the pivotal phase III trials (MARINA and ANCHOR) used monthly injections of ranibizumab for 2 years, the ongoing PIER, PrONTO, and SAILOR trials are investigating less frequent dosing regimens, and preliminary results from the PrONTO study suggest that fewer injections will most likely result in visual acuity improvements similar to the results from the phase III trials. When comparing the ANCHOR results with the FOCUS results, it also becomes apparent that the combination of ranibizumab with PDT does not necessarily result in better visual acuity outcomes, and the use of PDT may even reduce the visual acuity benefits achieved with ranibizumab alone (see Figs. 1-3). It seems unlikely that combination therapy provides any significant advantage over ranibizumab alone unless the combination of PDT and ranibizumab can decrease the need for frequent retreatment. The results from the PrONTO Study already suggest that less frequent treatment with ranibizumab is possible by using a variable dosing regimen with OCT. Ranibizumab also seems to be safe, with the 2-year MARINA data showing no increase in the incidence of systemic adverse events that could be associated with anti-VEGF therapy, such as myocardial infarction and stroke. There was a hint of a safety concern, however, in the pooled 1-year safety results from the MARINA and ANCHOR trials. Although the combined rate of myocardial infarction and stroke during the first year of the ANCHOR and MARINA trials was similar in the control and the 0.3-mg ranibizumab arms (1.3% and 1.6% respectively), these adverse events were slightly higher in the 0.5-mg ranibizumab arm (2.9%). These differences are not statistically significant, however, and probably do not represent a dose-dependent increase in risk because the 2-year results from the MARINA trial with the same monthly injection regimen showed no increased risk of thromboembolic events. In December 2005, Genentech submitted a Biologics License Application to the FDA for the use of ranibizumab in the treatment of neovascular wet AMD based on 1-year clinical efficacy and safety data from the two pivotal phase III trials, ANCHOR and MARINA, and the phase I-II FOCUS trial. Genentech has been granted a 6-month Priority Review from the FDA with a decision anticipated 6 months from the December submission date or by the end of June 2006 [29]. By the summer of 2006, this revolutionary therapy should be available for the treatment of neovascular AMD. At that time, the major dilemma facing most retina specialists will be whether to use intravitreal ranibizumab or intravitreal bevacizumab, the low cost alternative, for the treatment of neovascular AMD.

The timing of intravitreal Ranibizumab therapy after cataract surgery in patient with diabetic macular edema

Objective To investigate the timing of intravitreal ranibizumab injection after phacoemulsification for the patients with diabetic macular edema (DME). Methods Forty-six eyes of 46 patients with DME who underwent phacoemulsification surgery were randomly divided into observation group (n=25) and control group (n=21). An intravitreal injection of ranibizumab (0.05 ml of solution at 10 mg /ml) was performed immediately after cataract surgery in the patients of observation group, and 4 weeks after surgery in control group. The main outcome measures included the best corrected visual acuity (BCVA), central retina thickness (CRT), macular edema grades, intraocular pressure (IOP) and blood sugar. Results Before phacoemulsification surgery, BCVA (logMAR) in observation group and control group were 0.67±0.15 and 0.70±0.21 respectively (t=1.013, P>0.05). But 16 weeks after phacoemulsification surgery, the BCVA (logMAR) in observation group was 0.45±0.35 which was better than that 0.51±0.27 in control group (t=5.239, P<0.05). The CRT in observation group and control group were changed from preoperative (495.93±203.71) μm and (501.32±172.65) μm to postoperative (435.93±190.46) μm and (441.85±188.54) μm, respectively. Meanwhile, CRT in observation group was better than that in control group after intraviteal ranibizumab injection. Comparing with that before injection, the percentage of DME patients was decreased to 80% in observation group, but it was unchanged in control group 4 weeks after intravitreal ranibizumab injection. No complication, such as endophthalmitis, retinal hemorrhage, retinal detachment, ocular hypertension or systemic thrombosis occurred in the patients of two groups after ranibizumab injection. Conclusion The treatment of intravitreal ranibizumab after phacoemulsification is effective for patients with DME and Ranibizumab injection should be performed after cataract surgery immediately, thus is better for DME treatment. Key words: Diabetes, type 2; Edema, macular; Phacoemulsification; Ranibizumab, intravitreal injection

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Ranibizumab

Application of anti-VEGF agents in treatment of neovascular glaucoma and anti-scarring in filtering surgery

Neovascular glaucoma (NVG) is a group of secondary glaucoma which led by a variety of diseases that have anoxia or ischemia to the retina. Some studies have found that the etiology was related to the vascular endothelial growth factor (VEGF). At present, anti-VEGF as a treatment method to NVG, has become an important advance in the field of glaucoma research, which established a new way to improve the prognosis. This review mainly focused on the pathophysiologic basis and clinical research of NVG, fundamental research and applications about four kinds of anti-VEGF agents (Bevacizumab, Ranibizumab, Pegaptanib and Aflibercept) and application of treatment of NVG and anti-scarring in filtering surgery. The review also provided references for the clinical treatment of NVG and improving the success rate of operation.

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Ranibizumab

The effect of intravitreal injection of ranibizumab and pan-retina photocoagulation in the treatment of severe proliferative diabetic retinopathy wih 23G vitreoretinal surgery

Objective To observe the different effect of 23G vitrectomy surgery assisted with intravitreal injection of ranibizumab and pan-retina photocoagulation in severe proliferative diabetic retinopathy (PDR) treatment. Methods A total of 60 patients (78 eyes) with severe PDR diagnosed were enrolled and divided into intravitreal injection of Lucentis group (Group A, 22 patients, 28 eyes), pan-retina photocoagulation group (Group B, 18 patients, 20 eyes) and control group (Group C, 20 patients, 30 eyes), all of them received 23G vitreoretinal surgery. The average operation time, iatrogenic hiatus, the use of filler and electric coagulation, postoperative bleeding and best corrected visual acuity in three months were comparatively analyzed among the three groups. Results The operation time in the three group was (67.429±11.243), (77.762±10.435), (106.839±20.724) min respectively, the differences of A vs C and B vs C were statistically significant(t=8.940, 5.928; P 0.05). The best corrected visual acuity of 3 months after surgery in the three group is (0.383±0.122), (0.251±0.067), (0.104±0.044) respectively, the differences of A vs C and B vs C were all statistically significant(t=11.909, 13.616; P<0.05). Conclusion The intravitreaI injection of ranibizumab or pan-retina photocoagulation treatment before the vitrectomy surgery is very effective, both of them can shorten the operation time, reduce electric coagulation and use of filler, and improve patients' eyesight. Key words: Diabetic retinopathy/therapy; Angiogenesis inhibitors/therapeutic use; Antibodies, monoclonal/therapeutic use; Laser coagulation; Vitrectomy

Clinical characteristics and combined treatment for choroidal neovascularization secondary to angioid streaks

Objective To investigate the clinical characteristics and evaluate photodynamic therapy treatment combined with intravitreal injection of Lucentis for choroidal neovascularization secondary to angioid streaks. Methods This was an interventional retrospective analysis of 21 patients (42 eyes). For clinical data, best corrected visual acuity (BCVA), fundus appearance, fundus fluorescence angiography (FFA) , indocyanine green angiography (ICGA) and optical coherence tomography (OCT) were assessed. Twenty-two eyes of 18 patients with macular choroidal neovascularizaiton (CNV) were treated first with photodynamic therapy (PDT) and then with an intravitreal injection of Lucentis. The patients were followed up for at least 12 months. Another injection was given if one of the following appeared: decreased visual acuity, new macular lesions, subretinal or intraretinal fluid, or CNV leakage. Data were analyzed using an independent-samples t test or a paired-samplest test. Results Both eyes of all 21 patients were involved. Only 5 patients (24%) had complications with hologathy. Males were more affected (76%). Of all the patients, 18 cases (86%) were diagnosed with CNV secondary to AS. BCVA was much worse in eyes with CNV. At the final follow-up after the combination treatment, BCVA had improved 10.4 characters. OCT showed macular retinal thickness decreased from 338.4±55.2 μm at baseline to 212.6±36.2 μm. FFA (ICGA) showed CNV leakage in 15 eyes (68%) had disappeared completely, and 5 eyes had scar staining. All patients received 1 treatment of PDT and a mean 3.2 intravitreal injections. Macular subretinal hemorrhage presented in 1 patient after PDT, but was absorbed completely after intravitreal injection. Five patients presented with transient elevated intraocular pressure and 4 patients had subconjunctival hemorrhage but all recovered quickly. No other ocular or adverse reactions occurred. Conclusion Angioid streaks present a special fundus appearance, and FFA(ICGA) is valuable in the diagnosis. A considerable proportion of patients are affected with CNV secondary to AS. PDT treatment combined with intravitreal injection of Lucentis is effective in preventing disease progression, improving visual acuity, and reducing CNV leakage. Adverse reactions are mild. Key words: Angioid streaks; Choroidal neovascularization; Fluorescein angiography; Photochemo therapy; Vascular endothelial growth factor A