- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Nonclinical toxicology and biocompatibility program supporting clinical development and registration of the Port Delivery System with ranibizumab (Exhibit Hall: Posterboard# B0024) - Mar 9, 2020 - Abstract #ARVO2020ARVO_3595;
Biocompatibility of the implant and ancillary devices were evaluated in both in vitro and in vivo studies.Results Implants and extracts of implants and ancillary devices were non-genotoxic, non-cytotoxic, non-sensitizing, and non-irritating. Ocular findings were comparable between implanted and sham-operated eyes, and no systemic toxicity was observed.Conclusions The results of this nonclinical toxicology program demonstrated that the PDS was biocompatible and that intravitreal delivery of ranibizumab via the PDS did not introduce any new toxicology-related safety concerns relative to intravitreal injections, supporting ongoing PDS clinical development and product registrational evaluation.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
PREDICTIVE RESPONSE FACTORS AND PROGRESSION TO INTRAVITREAL TREATMENT IN AGE RELATED MACULAR DEGENERATION REFRACTORY TO RANIBIZUMAB. (Exhibit Hall: Posterboard# B0058) - Mar 9, 2020 - Abstract #ARVO2020ARVO_3225;
At 6 months after the change, the value of the CMT decreased from 298.72 ± 91.9 (base value) to 276 ± 90 microns (p = 0.047).A comparative study of intraretinal fluid (IRF) was performed with the McNemar test and that feature vanish in 15 of the 26 eyes (p = 0.002) at six months.Likewise, 45 eyes presented subretinal fluid at baseline and only 33 maintained it, assuming a reduction of 26.67% (p = 0.027).The improvement at six months in terms of the disappareance of the cyst was remarkable. Just 18 of 30 eyes with cyst at baseline remained (p= 0.017).Conclusions The switch to aflibercept in patients with AMD with long-term evolution refractory to treatment with ranibizumab does not improve the functional results at 6 months but there is an anatomical benefit that results in a significant reduction in CMT and intra-subretinal fluid.The persistence of activity was associated to a greater progression of central macular fibrosis and atrophy.
- |||||||||| Avastin (bevacizumab) / Roche, Eylea (aflibercept intravitreal) / Bayer, Regeneron, Lucentis (ranibizumab) / Roche, Novartis
OXB-203, a lentiviral vector expressing aflibercept as a single dose, long-term treatment for wet Age-Related Macular Degeneration (Exhibit Hall: Posterboard# A0191) - Mar 9, 2020 - Abstract #ARVO2020ARVO_3032;
However, development of new treatments are necessary as current anti-VEGF treatments are only effective for 1-2 months and as such require frequent injections for an extended period of time causing a significant burden to patients and are associated with side effects such as inflammation, haemorrhage and retinal detachment.Methods Clinical data from OXB-201, our first-generation treatment for wet AMD (equine infectious anemia virus (EIAV)-endostatin and angiostatin) program (Campochiaro et al, 2017) demonstrated that following a single subretinal injection of the vector in patients, there is stable long term expression of the transgenes out to 6 years providing proof-of-principle for this type of single-injection gene therapy approach...In vitro angiogenesis assays demonstrated that both cell proliferation and tubule formation were significantly inhibited with vector-derived aflibercept similar to that of recombinant aflibercept. In a preclinical study using a rat choroidal neovascularization (CNV) model, a single subretinal administration of OXB-203 vector demonstrated excellent expression of aflibercept in the vitreous and reduction in CNV lesion sizes comparable to recombinant aflibercept delivered intravitreally.Conclusions Our data indicates that a single dose of OXB-203 is an effective anti-neovascularisation gene therapy product for wet AMD.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Management Patterns and Outcomes for Intravitreal Injection-Related Endophthalmitis (Room 308) - Mar 9, 2020 - Abstract #ARVO2020ARVO_2871;
Eyes presenting with VA of hand motion at 1 foot (20/8000) or worse were more likely to undergo subsequent PPV (p = 0.02).Conclusions Eyes with VA of hand motion at 1 foot (20/8000) or worse were more likely to undergo subsequent PPV. Earlier vitrectomy may be considered in these patients.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Refractive outcomes after anti-VEGF injections followed by laser photocoagulation for the residual avascular retina in ROP (Exhibit Hall: Posterboard# B0072) - Mar 9, 2020 - Abstract #ARVO2020ARVO_2682;
This demonstrates that eyes which received laser for threshold disease had a higher incidence of myopia compared to eyes which received laser for avascularity.Conclusions Laser for avascular retina after treatment with anti-VEGF did not induce a myopic shift at the time of refraction in our study group, and all the eyes were found to be plano or slightly hyperopic. However, laser for threshold disease induced significant myopia compared to laser for avascular retina.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Retinotopic cortical mapping as an objective functional monitoring tool of macular therapy (Exhibit Hall: Posterboard# B0344) - Mar 9, 2020 - Abstract #ARVO2020ARVO_2307;
Here we develop an objective, user-independent method based on brain mapping using functional magnetic resonance imaging (fMRI) for monitoring macular function under therapeutic intervention.Methods 20 patients with neovascular age-related macular degeneration (nAMD) were studied with high-field, high-resolution fMRI, BCVA testing, RA, CS and MP before and after 3 monthly intravitreal injections of ranibizumab...This demonstrates the potential of retinotopic mapping for quantitative, topographic measurement of visual function independent of patient compliance. This makes fMRI-based brain mapping ideally suited for monitoring retinal gene therapy effects.
- |||||||||| Eylea (aflibercept intravitreal) / Bayer, Regeneron, Lucentis (ranibizumab) / Roche, Novartis
SJP1804, an eye drop formulation of a novel NADPH oxidase inhibitor, for the treatment of wet AMD. (Exhibit Hall: Posterboard# B0262) - Mar 9, 2020 - Abstract #ARVO2020ARVO_2223;
Purpose Anti-VEGF therapy such as aflibercept and ranibizumab, which requires regular intravitreal (IVT) injections, is currently only available treatment for wet age-related macular degeneration (wAMD)...It is noteworthy that non-invasive eye drop of the SJP1804 was effective in the CNV models. The verified effective concentrations of the SJP1804 in the rabbit retina/choroid after eye drop application further support the contention.Conclusions Taken together, the results showed that the superior or equivalent efficacy of the SJP1804 (eye drop) compared to aflibercept (IVT) in mouse and rabbit CNV models, suggesting SJP1804 as a potential non-invasive therapeutic drug in the treatment of wAMD.
- |||||||||| Eylea (aflibercept intravitreal) / Bayer, Regeneron, Lucentis (ranibizumab) / Roche, Novartis
Home monitoring for patients with diabetic macula oedema: my doctor knows how I’m seeing every day. (Exhibit Hall: Posterboard# A0304) - Mar 9, 2020 - Abstract #ARVO2020ARVO_2011;
We aim to do this by understanding the fluctuations in vision between patient’s hospital appointments, via the use of a smartphone based app 'Alleye' by patients which provides scores for vision at home that doctors can access via a web platform remotely. Based on this, we hope to compare these scores to the information normally collected at hospital visits and understand if it is the same or if it provides new information that could help us personalize treatment intervals for patients.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Changes in level of plasma von Willebrand factor before and after intravitreal anti-VEGF injections in eyes with retinal vein occlusion (Exhibit Hall: Posterboard# B0391) - Mar 9, 2020 - Abstract #ARVO2020ARVO_1733;
In the ranibizumab group (n=16), the VWF antigen level was changed significantly before and after the injection; 133.8% before and 121.5% at one day and 156.6% at one week after the injection (P=0.0023)...In the ischemic RVO group (n=15), there was no significant difference in the VWF antigen level before and after treatment (P=0.097), while in the non-ischemic RVO group (n=30), there was a significant decrease after injection (P=0.0075). The ADAMTS13 activity did not change before and after treatment for all types of anti-VEGF agents.Conclusions The decrease in the plasma VWF antigen level after an intravitreal anti-VEGF injection in eyes with RVO supports the idea that the high levels of VWF were enhanced by VEGF released from organelles of endothelial cells.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Clinical Outcomes of Neovascular Glaucoma Treated with Intravitreal Anti-Vascular Endothelial Growth Factor Injection (Exhibit Hall: Posterboard# B0384) - Mar 9, 2020 - Abstract #ARVO2020ARVO_1726;
No factors were significant predictors for worsening VA at 3 months.Conclusions Worse baseline VA and female gender were correlated with an increased risk of requiring glaucoma surgery in the setting of NVG treated with intravitreal anti-VEGF agents. However, worse VA at 3 months was not correlated with age, number of glaucoma drops per day, increased IOP, gender, or VA at time of diagnosis.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Correlation of Intraocular Cytokine Expression with Higher Order OCT Features in Retinal Venous Occlusive Disease (Exhibit Hall: Posterboard# B0375) - Mar 9, 2020 - Abstract #ARVO2020ARVO_1717;
The purpose of this study is to correlate underlying cytokine expression with extracted higher order OCT imaging features, including as intraretinal fluid volume and outer retinal integrity measures in eyes with retinal vein occlusion (RVO).Methods The WAVE study is a prospective clinical trial for management of RVO comparing ranibizumab monotherapy to ranibizumab combined with targeted panretinal photocoagulation...Higher presenting VEGF and MMP-9 are associated with increased macular edema, while increased ANG-1, AgRP, MMP-9, and uPAR correlate with decreased ellipsoid zone integrity. Future research will clarify the longitudinal cytokine dynamics in retinal vein occlusion and whether these imaging biomarkers can predict treatment response.
- |||||||||| faricimab (RG7716) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Clinical Effects of Blocking Ang-2 and VEGF with Faricimab in the Phase 2 STAIRWAY Trial (Ballroom I) - Mar 9, 2020 - Abstract #ARVO2020ARVO_1499;
P2
Faricimab-treated patients also showed similar reductions in the size of lesions and area of leakage caused by abnormal blood vessels, compared with monthly Lucentis® (ranibizumab). These results show that the outcomes achieved with faricimab given every 16 or 12 weeks are comparable with those achieved with Lucentis® (ranibizumab) given every 4 weeks, suggesting that similar improvements can be achieved with fewer faricimab injections compared with Lucentis® (ranibizumab).
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Pharmacokinetic (PK) Profile of the Port Delivery System with Ranibizumab (PDS) in the Phase 2 Ladder Trial (Ballroom I) - Mar 9, 2020 - Abstract #ARVO2020ARVO_1496;
P2
For all three PDS arms, the serum concentration versus time profiles were consistent following implant insertion and across multiple refills.Conclusions The PDS implant continues to release ranibizumab for an extended period of time, including through Month 16 in the PDS 100 mg/mL arm. These findings explain the median time to first refill of 15.8 months observed in PDS 100 mg/mL patients in the Ladder trial, which was associated with sustained visual gains that were comparable to monthly intravitreal ranibizumab.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Factors associated with visual outcome after anti-vascular endothelial growth factor therapy in myopic choroidal neovascularization (Exhibit Hall: Posterboard# B0415) - Mar 9, 2020 - Abstract #ARVO2020ARVO_1443;
Purpose To determine factors associated with visual outcome after anti-vascular endothelial growth factor (anti-VEGF) therapy in patients with myopic choroidal neovascularization (mCNV).Methods Medical charts of the 24 eyes of 24 patients who were diagnosed with mCNV at the Medical Retina Division Clinic of the Department of Ophthalmology, Keio University Hospital between May 2014 and December 2017, and treated with either intravitreal ranibizumab (IVR) or aflibercept (IVA) monotherapy in a PRN regimen for 12 months were retrospectively analyzed...These eyes had better BCVA (P=0.017), and lower normalized mCNV intensity (P=0.047), at baseline compared with the others who had worse BCVA at month 12. There was no difference in the mCNV height at baseline between the groups.Conclusions The findings in this study suggested that patients with mCNV may have better BCVA after 12 months of anti-VEGF therapy in a PRN regimen, if the patients were treated before their BCVA became worse, and if the mCNV had less intensity in OCT images at baseline, although further studies are required.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
A translational framework for the prediction of durability of new anti-VEGF therapies (Exhibit Hall: Posterboard# B0357) - Mar 9, 2020 - Abstract #ARVO2020ARVO_1395;
The framework relies on the use of ranibizumab as reference compound, for which the translatability of durability from monkey to human is verified. Early predictions of VEGF suppression support rational drug optimization, allow ranking against competitors and enable optimal first-in-human trial design.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Safety evaluation after repeated intravitreal injections of an anti VEGF-A mAb versus ranibizumab in New Zealand white rabbits. (Exhibit Hall: Posterboard# B0369) - Mar 9, 2020 - Abstract #ARVO2020ARVO_534;
Clinical examination found absence of edema and flare at 29, 60 and day 91. The safety of both drugs was similar, since neither presented differences in blood test and post-mortem findings (necropsy).Conclusions All the safety variables studied in this preclinical study confirm that the safety profile of both treatments, PRO-169 or ranibizumab, is similar in rabbits after repeated Itv injections.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Müller cell edema was reduced by anti-VEGF treatment in diabetic retinopathy (Exhibit Hall: Posterboard# B0287) - Mar 9, 2020 - Abstract #ARVO2020ARVO_526;
Ranibizumab increased the protein expression of Na+-K+-ATPase and decreased intracellular sodium level, but not potassium.Conclusions Ranibizumab protected Müller cells from intracellular edema through up-regulation of Kir4.1, AQP4, and Dp71 by direct binding VEGF-A. It also increased the expression of Na+-K+-ATPase, contributing to reduce the intracellular osmotic pressure.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Association of Aqueous Cytokine Profile and Extracted OCT Features in Diabetic Macular Edema: Assessment of the Anatomic-Biologic Bridge (Exhibit Hall: Posterboard# A0022) - Mar 9, 2020 - Abstract #ARVO2020ARVO_250;
The purpose of this study is to evaluate the association of specific quantifiable OCT characteristics and the expression of intraocular cytokines.Methods The DAVE study is a prospective clinical trial for the management of DME with ranibizumab or ranibizumab combined with targeted panretinal photocoagulation...Several cytokines, including MCP-1 and LIF, correlated with decreased ellipsoid zone integrity. Further research is needed to evaluate the potential for OCT-derived biomarkers that may provide insights into the underlying expressed cytokine profile.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Journal: The LXXV Edward Jackson Memorial Lecture: Lessons Learned from Avastin and OCT: The Great, The Good, The Bad, and The Ugly. (Pubmed Central) - Mar 9, 2020
MA growth rates were associated with ocular factors in the study eyes and the fellow eyes but not with the drug or the number of injections within this variable dosing regimen. The rapid adoption of OCT-guided therapy and the use of intravitreal bevacizumab by the global retinal community has prevented blindness from exudative and neovascular ocular diseases worldwide while saving healthcare providers and patients billions of dollars.
- |||||||||| Avastin (bevacizumab) / Roche, Eylea (aflibercept intravitreal) / Bayer, Regeneron, Lucentis (ranibizumab) / Roche, Novartis
[VIRTUAL] RISK OF ISCHEMIC COLITIS IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION TREATED WITH INTRAVITREAL ANTI-VEGF AGENTS () - Mar 8, 2020 - Abstract #ISPOR2020ISPOR_1651;
Ischemic colitis is uncommon in patients treated with anti-VEGF agents, occurring in approximately 1.1 to 1.4 per 1,000 patients, and, in crude analysis, it does not appear to differ meaningfully between different medications. However, the small number of events in each treatment group limits statistical interpretation and precludes analysis that would control for potential confounding factors, such as age or treatment with other medication.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
[VIRTUAL] COST-MINIMIZATION ANALYSIS OF RANIBIZUMAB VERSUS AFLIBERCEPT IN THE TREATMENT OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN COLOMBIA () - Mar 8, 2020 - Abstract #ISPOR2020ISPOR_1644;
If all patients with neovascular ARMD in Colombia receive anti-VEGF therapy between the years 2020 and 2025, the minimal expected savings for the Colombian health care system with the use of ranibizumab as compared to aflibercept could be close to U.S. $ 497,249,492. CONCLUSIONS In the Colombian health care setting and for a five-year projection beginning 2020, anti-VEGF therapy on a TAE regimen utilizing ranibizumab for neovascular ARMD may be cost saving compared with the administration of aflibercept.
- |||||||||| NN1213 / Novo Nordisk, Lucentis (ranibizumab) / Roche, Novartis
Trial completion date, Trial primary completion date: Noctura400 Treatment for Diabetic Retinopathy (CANDLE) (clinicaltrials.gov) - Mar 4, 2020
P=N/A, N=252, Active, not recruiting,
According to elaborate post hoc analyses, the most likely reason was insufficient exposure in the target compartment (back of the eye). Trial completion date: Jan 2020 --> Jul 2020 | Trial primary completion date: Jan 2020 --> Jul 2020
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Biomarker, Journal: MEASUREMENTS OF RETINAL FLUID BY OCT LEAKAGE IN DIABETIC MACULAR EDEMA: A Biomarker of Visual Acuity Response to Treatment. (Pubmed Central) - Mar 3, 2020
Trial completion date: Jan 2020 --> Jul 2020 | Trial primary completion date: Jan 2020 --> Jul 2020 Optical coherence tomography leakage changes after anti-vascular endothelial growth factor treatment of diabetic macular edema, identifying the degree of decrease in retinal fluid in the outer layers of the retina is a more robust biomarker of BCVA recovery than central retinal thickness, disorganization of the inner retinal layer, or ellipsoid zone disruption changes.
- |||||||||| Zaltrap (ziv-aflibercept IV) / Sanofi, Regeneron, Humira (adalimumab) / Eisai, AbbVie, Lucentis (ranibizumab) / Roche, Novartis
Journal: Comparison of Ophthalmic Medication Prices Between the United States and Australia. (Pubmed Central) - Mar 3, 2020
Results of this study indicate that the prices of adalimumab, ranibizumab, and aflibercept significantly decreased during the past 5 years in Australia compared with the United States. These data do not indicate why these differences are noted or what actions might affect future pricing in either country.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Effect on Corneal Endothelium Following Intra Vitreal Injection of Ranibizumab in Age Related Macular Degeneration (BCEC-Meeting Level 1,Room 151A) - Mar 1, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_1272;
The Pre operative Corneal Endothelial count was found to be similar with no statistical significant difference between the post IV injection at 7 days (t=1.198, p=.234) and post 6 months (t= 1.094, p=0.311) respectively. Conclusion Repeated dose of intra vitreal injection of ranibizumab (0.5mg) has no statistically significant effect on corneal endothelium and central corneal thickness at 6 months.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Clinical Assessment of Surgical Treatment of Acute Postoperative Endophthalmitis (BCEC-Meeting Level 1,Room 151A) - Mar 1, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_665;
19 clinical cases were after cataract phacoemulsification, 7 after vitreoretinal surgery, and 1 after intravitreal injection of ranibizumab...No Vancomycin-resistant cultures were identified...Conclusion These data prove prevalence of gram-positive culture among the reasons of acute postoperative endophthalmitis. Urgently performed vitreoretinal surgery with intravitreal injection of antibiotics allows to restore visual functions in cases of acute postoperative endophthalmitis.
- |||||||||| Eylea (aflibercept intravitreal) / Regeneron, Lucentis (ranibizumab) / Roche, Novartis
Enrollment closed, Trial completion date, Trial primary completion date: VITCLEAR: A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy. (clinicaltrials.gov) - Feb 25, 2020
P=N/A, N=62, Active, not recruiting,
This decrease in visit number could improve patients' quality of life and reduce surgical risk by reducing the number of injections. Recruiting --> Active, not recruiting | Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Retrospective data, Journal: Retinal and Choroidal Changes after Anti Vascular Endothelial Growth Factor Therapy for Neovascular Age-related Macular Degeneration. (Pubmed Central) - Feb 24, 2020
Recruiting --> Active, not recruiting | Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Jun 2019 --> Jun 2020 Excessive long-term vascular endothelial growth factor inhibition by an anti-vascular endothelial growth factor agent that is trapped by neuronal and retinal pigment epithelium cells may adversely affect the function of physiological vascular endothelial growth factor and harm retinal cells and vessels.
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