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Effect of intravitreal ranibizumab on the ocular circulation of the untreated fellow eye.

ABSTRACT: To evaluate the effects of unilateral intravitreal ranibizumab (IVR) on the ocular circulation of the fellow eyes.Fifteen eyes of 15 patients with macular edema (average age 69.6 ± 11.8 years) were studied. Eleven eyes had diabetic macular edema (DME) and four eyes had macular edema associated with a branch retinal vein occlusion. Each eye received 0.5 mg of IVR. The blood circulation on the optic nerve head of the treated and untreated eyes were determined by laser speckle flowgraphy (LSFG, Softcare Co., Ltd) before, 1 day, and 1 week after the IVR. The mean blur rate (MBR) and the relative changes of the MBRs determined as dMBR(%) = 100-(MBR before/MB after) × 100) were evaluated. The central macular thickness (CMT) and the rate of reduction in the thickness (dCMT = 100-(CMT before/CMT after) × 100) were also evaluated.The mean dMBR was significantly higher in the treated eyes than the untreated eyes at 1 day (-16.4 ± 17.0% vs 2.31 ± 19.3%) and at 1 week (-12.0 ± 14.6% vs 4.50 ± 25.9%) after the IVR (P = 0.02, paired t tests).These findings indicate that if ranibizumab enters the systemic circulation, the concentration is not high enough to affect the ocular circulation of the fellow eyes.

SUBMITTER: Sugimoto M

PROVIDER: S-EPMC5541094 | biostudies-other | 2017 Aug

REPOSITORIES: biostudies-other

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Intravitreal bevacizumab versus ranibizumab: Effects on the vessels of the fellow non-treated eye.

Project description:PurposeTo evaluate the effects of anti-vascular endothelial growth factors (anti-VEGF) on the vessels of the non-treated eyes following intravitreal injections.MethodsIn this prospective, non-randomized trial, a total of 38 patients were recruited. 21 patients received ranibizumab, and 17 patients received bevacizumab. Fundus photography was carried out at baseline immediately before injection and at 3 days, 7 days, and one month after the injections. Using image analysis software, measurements were summarized as the central retinal artery equivalent (CRAE) and central retinal vein equivalent.ResultsIn non-treated eyes, CRAE decreased significantly from 153.23 ± 15.20 μm before injection to 148.77 ± 17.21 μm 3 days after intravitreal bevacizumab (P = 0.004). There was no significant difference in CRAE, between the pre-injection baseline, one week, and one month after intravitreal bevacizumab injection in non-treated eyes (P > 0.05). No significant difference was noted in CRAE in the non-treated eyes of the ranibizumab group at any post-injection visit (P = 0.1).ConclusionA significant transient narrowing effect of bevacizumab on retinal arterioles in the fellow non-treated eyes on the third day after intravitreal injection may show that plasma concentrations of these drugs are sufficient to spread the effect to the other eye.

| S-EPMC6407068 | biostudies-literature

Multiple Intravitreal Ranibizumab Injections for Persistant Choroidal Neovascularization Associated with Presumed Ocular Histoplasmosis Syndrome.

Project description:Presumed ocular histoplasmosis syndrome (POHS) is a clinical entity that is characterized by small, round, discrete, macular or mid peripheral atrophic (punched out) chorioretinal lesions (histo spots), peripapillary scarring, choroidal neovascularization (CNV), and the absence of anterior uveitis and vitritis. Diagnosis of this disorder is based upon characteristic clinical findings and a positive histoplasmin skin test or residence in an endemic region for Histoplasma capsulatum. There is no active systemic disease during diagnosis of POHS. Disciform scarring and macular CNV secondary to POHS is a well-known complication which leads to loss of visual acuity or visual disturbance. Without therapy, the visual prognosis in these patients is unfavorable. Submacular surgery, radiation, steroids, photodynamic therapy, and most recently anti-vascular endothelial growth factor therapy are current therapeutic options for this condition. We report a case with persistent CNV secondary to POHS in a middle-aged woman with moderate myopia and the clinical course of treatment with multiple intravitreal ranibizumab (Lucentis®, Novartis) injections.

| S-EPMC5384118 | biostudies-other

Idiopathic Choroidal Neovascularization: Intraocular Inflammatory Cytokines and the Effect of Intravitreal Ranibizumab Treatment.

Project description:Idiopathic choroidal neovascularization (ICNV) is a disorder that primarily affecting patients younger than 50 years and can cause severe loss of vision. Choroidal abnormalities, especially choroidal inflammation, have been thought to be involved in the pathophysiology of ICNV. However, the exact pathogenesis of ICNV remains unclear. The aim of our study was investigate the levels of 27 inflammatory cytokines in the aqueous humor of eyes with ICNV, and to determine the effect of intravitreal injection of ranibizumab (IVR) on cytokine levels. Significantly higher levels of IL-2, IL-10, IL-15, IL-17, basic FGF, and GM-CSF were observed in patients with ICNV compared with controls. However, only IL-17 levels were significantly higher in patients with ICNV compared with controls after adjusting for axial length. Furthermore, there were significant correlations between the levels of IL-10, IL-17, GM-CSF, and VEGF and the lesion area. Significant changes in visual acuity and central retinal thickness were observed after IVR. Besides VEGF, IVR also significantly reduced the levels of IL-2, IL-10, basic FGF, and IL-12, however, the IL-6 levels were significantly increased. Our results suggest that there may be an involvement of IL-17-related inflammatory processes in the etiology of ICNV.

| S-EPMC4997256 | biostudies-literature

Effect of intravitreal ranibizumab and aflibercept injections on retinal nerve fiber layer thickness.

Project description:The purpose is to evaluate the effects of multiple intravitreal ranibizumab (IVR) and aflibercept (IVA) injections on peripapillary retinal nerve fiber layer (RNFL) thickness in patients with exudative age-related macular degeneration (AMD). This retrospective, observational, consecutive case series study enrolled patients newly diagnosed with monocular exudative AMD from January 2014 to October 2019 who were administered IVR or IVA injections. Normal fellow eyes were included as controls. Medical records and spectral domain optical coherence tomography results were reviewed at baseline and at 3, 6, and 12 months after injection. No statistically significant differences in peripapillary RNFL thickness and intraocular pressure were observed between the treated and fellow eyes in the two groups. The global RNFL thicknesses for the treated eyes decreased significantly after 12 months compared with baseline, but no significant difference was observed in any of the six examined sectors (temporal, superior temporal, superior nasal, nasal, inferior nasal, and inferior temporal). At 12 months, the central macular thickness of the treated eyes decreased significantly. Multiple IVR and IVA injections are apparently safe considering peripapillary RNFL damage in patients with exudative AMD. The decreased RNFL thickness of the global sector was presumably due to anatomical improvement of macular lesions.

| S-EPMC7930121 | biostudies-literature

SYSTEMIC PHARMACOKINETICS AND PHARMACODYNAMICS OF INTRAVITREAL AFLIBERCEPT, BEVACIZUMAB, AND RANIBIZUMAB.

Project description:To evaluate the systemic pharmacokinetics (PKs) of aflibercept, bevacizumab, and ranibizumab in patients with neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion (RVO).Prospective, open-label, nonrandomized clinical trial of patients with AMD, DME, or RVO who were antivascular endothelial growth factor (VEGF) naïve or had not received anti-VEGF for ?4 months. Patients received 3 monthly intravitreal injections of aflibercept 2.0 mg, bevacizumab 1.25 mg, or ranibizumab (0.5 mg for AMD/RVO, 0.3 mg for DME). The main outcome measures were serum PKs and plasma free-VEGF concentrations after the first and third injections.A total of 151 patients were included. In AMD/DME/RVO, systemic exposure to each drug was highest with bevacizumab, then aflibercept, and lowest with ranibizumab. Ranibizumab cleared from the bloodstream more quickly than bevacizumab or aflibercept. Aflibercept treatment resulted in the greatest reductions in plasma free-VEGF relative to baseline levels, whereas ranibizumab treatment resulted in the smallest decreases in plasma free-VEGF.The three anti-VEGF treatments examined in this analysis demonstrated notable differences in systemic PKs. Generally, the reduction in plasma free-VEGF levels correlated with elevated levels of circulating anti-VEGF agents, with the reduction in free-VEGF levels greatest with aflibercept and least with ranibizumab.

| S-EPMC5642319 | biostudies-literature

Human Herpesvirus-6 corneal Endotheliitis after intravitreal injection of Ranibizumab.

Project description:BackgroundTo report the first case of human herpesvirus-6 (HHV-6) corneal endotheliitis that developed after intravitreal ranibizumab injections.Case presentationA 63-year-old man with a medical history of diabetes and systemic steroid treatment for bullous pemphigoid had been receiving intravitreal injections of ranibizumab in the left eye for 2 years according to a Pro Re Nata treatment regimen for macular edema associated with branch retinal vein occlusion. Twenty days after the last injection, the patient presented with pain and decreased visual acuity in his left eye. His best corrected visual acuity in the left eye was 2/200, and intraocular pressure was 45 mmHg with edema of the central stromal cornea, mild conjunctival injection, intermediate keratic precipitates, and mild anterior chamber reaction. HHV-6 DNA was detected in the aqueous humor using multiplex strip polymerase chain reaction, and it was identified as variant A, HHV-6A. A diagnosis of HHV-6A-associated corneal endotheliitis was made. Oral valganciclovir and topical ganciclovir therapy was initiated with good resolution of all symptoms and signs.ConclusionsHHV-6A can be a possible complication of intravitreal ranibizumab therapy. To the best of our knowledge, this is the first reported case of HHV-6A corneal endotheliitis following intravitreal ranibizumab injection.

| S-EPMC6335734 | biostudies-literature

Trans-Ocular Electric Current In Vivo Enhances AAV-Mediated Retinal Transduction in Large Animal Eye After Intravitreal Vector Administration.

Project description:PurposeElectric micro-current has been shown to enhance penetration and transduction of adeno-associated viral (AAV) vectors in mouse retina after intravitreal administration. We termed this: "electric-current vector mobility (ECVM)." The present study considered whether ECVM could augment retinal transduction efficiency of intravitreal AAV8-CMV-EGFP in normal rabbit and nonhuman primate (NHP) macaque. Potential mechanisms underlying enhanced retinal transduction by ECVM were also studied.MethodsWe applied an electric micro-current across the intact eye of normal rabbit and monkey in vivo for a brief period immediately after intravitreal injection of AAV8-CMV-EGFP. Retinal GFP expression was evaluated by fundus imaging in vivo. Retinal immunohistochemistry was performed to assess the distribution of retinal cells transduced by the AAV8-EGFP. Basic fibroblast growth factor (bFGF) was analyzed by quantitative RT-polymerase chain reaction (PCR). Müller glial reactivity and inner limiting membrane (ILM) were examined by the glial fibrillary acidic protein (GFAP) and vimentin staining in mouse retina, respectively.ResultsECVM significantly increased the efficiency of AAV reaching and transducing the rabbit retina following intravitreal injection, with gene expression in inner nuclear layer, ganglion cells, and Müller cells. Similar trend of improvement was observed in the ECVM-treated monkey eye. The electric micro-current upregulated bFGF expression in Müller cells and vimentin showed ILM structural changes in mouse retina.ConclusionsECVM promotes the transduction efficiency of AAV8-CMV-GFP in normal rabbit and monkey retinas following intravitreal injection.Translational relevanceThis work has potential translational relevance to human ocular gene therapy by increasing retinal expression of therapeutic vectors given by intravitreal administration.

| S-EPMC7416894 | biostudies-literature

Treatment patterns of ranibizumab intravitreal injection and dexamethasone intravitreal implant for retinal vein occlusion in the USA.

Project description:PurposeRanibizumab, an anti-vascular endothelial growth factor, and dexamethasone, a corticosteroid, have been shown to be effective in treating macular oedema secondary to retinal vein occlusion (RVO) (central RVO (CRVO) and branch RVO (BRVO)). Their real-world usage, however, has yet to be compared. We therefore evaluated ophthalmology visits for both drugs using US patient-level data.MethodsThe IMS Health Real-World Data Medical Claims database was used to identify treatment-naive patients receiving ranibizumab intravitreal injections or dexamethasone intravitreal implants between June 2010 and February 2014 who had 12 months of follow-up data. The primary outcome measure was the mean number of all ophthalmology visits for the two drugs in patients with CRVO and BRVO. Secondary outcome measures included a comparison of treatment visits, non-treatment visits, and time intervals between visits.ResultsOverall, 2822 patients received ranibizumab injections (CRVO, 1178; BRVO, 1644) and 365 received dexamethasone implants (CRVO, 191; BRVO, 174). The mean number (SD) of all ophthalmology visits was higher for patients receiving ranibizumab injections than for those receiving dexamethasone implants (CRVO: 7.2 (3.6) vs 6.2 (3.1), P<0.001; BRVO: 7.1 (3.4) vs 6.3 (3.1), P=0.016).ConclusionsPatients with RVO receiving ranibizumab injections had a mean of approximately one more visit to their ophthalmologist in the first 12 months of treatment than those treated with dexamethasone implants. The visit burden is therefore not substantially different and physicians should focus on the clinical benefits of these drugs when evaluating treatment options for RVO.

| S-EPMC5395996 | biostudies-literature

Intraocular Pharmacokinetics of 10-fold Intravitreal Ranibizumab Injection Dose in Rabbits.

Project description:PurposeTo investigate intraocular pharmacokinetics of 10-fold dose of intravitreally injected ranibizumab compared with the conventional dose in an experimental model.MethodsRanibizumab 30 µL at 10 mg/mL (conventional) and 100 mg/mL (10-fold) doses was injected separately into each eye of 28 rabbits. Ranibizumab concentrations in the aqueous humor, vitreous, and retina were estimated at each time period after injection, using enzyme-linked immunosorbent assay. The pharmacokinetic properties of ranibizumab were determined using a one-compartment model in all three ocular tissues. The time-concentration profile and predictive trends were plotted to determine drug efficacy in the retina.ResultsMaximum concentrations after conventional and 10-fold dosing were observed in the retina at 1 and 4 days after injection, respectively. The half-life of ranibizumab after conventional and 10-fold dosing did not differ in the anterior chamber and vitreous, whereas the half-life was prolonged approximately twice with the 10-fold dose in the retina (36.74 h vs. 76.85 h) and serum (91.93 h vs. 179.01 h). Similarly, the estimated time for ranibizumab concentration in the retina over 27 ng/mL (minimum effective concentration of ranibizumab) was prolonged approximately twice with the 10-fold dose (1315 h [55 days] vs. 2393 h [100 days]). No adverse effects were observed in either group.ConclusionsThe retinal half-life and concentration of ranibizumab in rabbit eyes were increased approximately twice after a 10-fold dose compared with the conventional dose. This finding indicates a possibility to lengthen the injection interval to improve the efficacy of ranibizumab in human eyes.Translational relevanceOur results highlight the potential for clinical application of a high-dose (10-fold) of anti-VEGF agents to prolong the intravitreal injection intervals, simultaneously improving the drug efficacy.

| S-EPMC7396190 | biostudies-literature

3-year-data of combined navigated laser photocoagulation (Navilas) and intravitreal ranibizumab compared to ranibizumab monotherapy in DME patients.

Project description:PURPOSE:The prospective, comparative evaluation of combined navigated laser photocoagulation and intravitreal ranibizumab in the treatment of diabetic macular edema has shown advantage of a combination therapy compared to ranibizumab monotherapy at year 1 with significantly reduced injections. The purpose of this retrospective study was to determine the long-term visual gains and need of injections in a 3 year-follow-up period. METHODS:Retrospective analysis of patients of the original study in the long-term follow-up from month 12 to 36. BCVA measurements following the original 1 year study were taken using logMAR charts. Injections were provided with standard of care using PRN, based on change in BCVA and CRT using SD-OCT scans. Main outcome measures were change in BCVA and mean number of injections from 12 to 36 months. RESULTS:BCVA was stable in both groups from 12 through 36 months, showing a change of 0.16 ± 0.1 log MAR. Following the initial reduction in required injections at month 12, combination therapy patients continued to require 1.3 times fewer injections over the next 24 months (2.91 ± 2.3 vs 3.85±3.7 injections for monotherapy). CONCLUSIONS:Combination of navigated laser and ranibizumab achieved BCVA gains equivalent to anti-VEGF monotherapy. These results could be maintained through month 36. Required injections were 2.0 injections lower in year 1 and further 1.3 times fewer in year 2 and 3 in the combination group compared to monotherapy. Adding navigated laser photocoagulation to intravitreal anti-VEGF therapy may still represent a superior therapeutic approach to DME patients.

| S-EPMC6107183 | biostudies-literature

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