- |||||||||| Lucentis (ranibizumab) / Roche, Novartis, abicipar pegol (AGN-150998) / Allergan, Molecular Partners
Quarterly Administration of the DARPin Therapeutic Abicipar in Neovascular Age-Related Macular Degeneration (Room 301) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5919;
The overall incidence of intraocular inflammation TEAEs was 15.4%, 15.3%, and 0.3% from baseline through Week 52 and 0.8%, 2.3%, and 1.0% from Week 52 through Week 104.Conclusions DARPin anti-VEGF therapy represents a powerful new technology that extends the duration of effect of anti-VEGF therapy and reduces treatment burden. Two-year results of the CEDAR and SEQUOIA studies confirm the efficacy and safety of quarterly dosing with abicipar in nAMD.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Novel Intravitreal Ranibizumab Delivery through Hyaluronic Acid Microparticle and Microparticle-Hydrogel Complex, and their in-vivo Efficacy and Safety (Exhibit Hall: Posterboard# B0181) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5719;
However, in Group C, slightly opaque gel-like material thought to be MP-hydrogel was observed nearby inner retina 60 days after the injection.Conclusions A novel MP and MP-hydrogel complex have been developed for prolonged intravitreal anti-VEGF delivery. We expect that MP and MP-hydrogel complex independently as a promising carrier to overcome the current challenges of intravitreal anti-VEGF therapy by sustaining anti-VEGF release and extending the interval between injections.
- |||||||||| Eylea (aflibercept intravitreal) / Bayer, Regeneron, Lucentis (ranibizumab) / Roche, Novartis
Efficacy of Ranibizumab plus Aflibercept Therapy with Dexamethosone Intravitreal Injection in Patients with Diabetic Macular Edema - 1 year follow-up (Exhibit Hall: Posterboard# B0024) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5630;
In G3 or G4 was 43.28% and 43.76%. The reduction was in G1 or G2 (32.82% and 30.23%) The VA observed a constant improvement, 2 lines (G1 and G2) and 4 lines (G3, G4, G5, G6).Conclusions We can state through this study that the treatment of diabetic macular edema with anti-VEGF associated with corticosteroid has a greater benefit than the treatment with these single drugs, shown by optical coherence tomography.Visual acuity increased with the association of drugs regardless of which antiangiogenic drug used.We can state through this study that the treatment of diabetic macular edema with anti-VEGF associated with corticosteroid has a greater benefit than the treatment with these single drugs.Visual acuity increased with the association of drugs regardless of which antiangiogenic drug used.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Intravitreal delivery of AAV2.7m8.ranibizumab suppresses exudative lesions in the NHP laser induced model of nAMD (Exhibit Hall: Posterboard# B0125) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5253;
AAV2.7m8.ranibizumab significantly inhibited the formation of exudative Grade IV lesions when compared to vehicle-treated eyes (25% and 24% in the vehicle-treated group compared to 2% and 0% for AAV2.7m8.ranibizumab, measured 2 and 4 weeks post-laser, respectively; p < 0.0001). The effect was comparable to efficacy observed following an IVT bolus of recombinant ranibizumab delivered immediately after the laser, and was confirmed by the reduction in size of fibrovascular complexes measured by OCT.Conclusions This work, together with the published preclinical results of ADVM-022, highlights the utility AAV2.7m8 as an effective gene therapy platform for the intravitreal delivery of anti-VEGF therapeutic proteins, and as such has demonstrated its potential for the treatment of CNV.
- |||||||||| Avastin (bevacizumab) / Roche, Eylea (aflibercept intravitreal) / Bayer, Regeneron, Lucentis (ranibizumab) / Roche, Novartis
Foveal capillary perfusion density decreases in diabetics with DME treated on a fixed regimen of intravitreal aflibercept injections over 24 months (Hall A) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5115;
Purpose To evaluate changes in capillary perfusion density (CPD) in patients with diabetic macular edema (DME) undergoing fixed intravitreal aflibercept injections (IAI) through 24 months in the SWAPTWO studyMethods SWAPTWO is a prospective, interventional, single arm study enrolling 20 patients with persistent DME despite prior treatment with bevacizumab or ranibizumab...There was no statistical significance correlation between final VA and the following: mean superficial fovea-only CPD values and deep foveal, parafoveal and whole CPD valuesConclusions Despite fixed q8week dosing with IAI after DME resolution through 24 months, both superficial and deep CPD measurements decreased, suggesting that perfusion continues to be affected despite fixed anti-VEGF dosing. Better final VA was correlated with less CPD loss within the superficial parafovea and “whole” (fovea+parafovea) areas
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
MicroRNA levels as a biomarker for anti-VEGF response in patients with diabetic macular edema (Hall A) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5110;
For miRNA-7, higher concentrations are associated with worse visual outcomes. Our findings suggest that circulating miRNA-133b and miRNA-7 may be positive and negative predictive biomarkers for better visual acuity outcome after anti-VEGF therapy, respectively.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
MFAP4 is an Effective Therapeutic Target in a Rabbit Model of Choroidal Neovascularization (CNV) (Ballroom III) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5096;
Once CNV growth had reached measurable size after one month, animals received 50µl intravitreal injections of anti-MFP4 (2mg), ranibizumab (Lucentis 0.5mg) or remained as untreated controls...At 2 months the anti-MFAP lesion size was smaller than anti-VEGF lesion size (p=0.064, t test)Conclusions We demonstrated a single intravitreal injection of anti-MFAP4 effectively reduced the CNV lesion size in the rabbit model. Using MFAP4 as alternative target to VEGF could be used as novel strategy, particularly in patients who respond poorly to anti-VEGF treatments.
- |||||||||| Zaltrap intravitreal (ziv-aflibercept intravitreal) / Regeneron, Sanofi, Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Ziv-aflibercept Efficacy in Better Regulating Neovascular AMD (ZEBRA) Trial (Room 314) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5062;
Compared to aflibercept, ziv-aflibercept is non-inferior with respect to anatomy, function, and complication rate. Due to ziv-aflibercept’s efficacy and relatively low cost, it may represent an important addition to current anti-VEGF treatment options, especially as a cost-effective alternative to aflibercept and a second-line therapy for eyes resistant to bevacizumab.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Macular atrophy incidence and progression in 5-year treatment of exudative age-related macular degeneration (Exhibit Hall: Posterboard# A0322) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4916;
Over the period of treatment, the total increase in MA lesion size from baseline through year five was 316%.Conclusions In the long-term treatment of exudative AMD with intravitreal anti-VEGF agents, macular atrophy has a high incidence and demonstrates a steady progression in lesion size over 5 years. OCT and SLO near-infrared images, ubiquitous in routine retina practice, provide extensive patient data to analyze macular atrophy over the extended course of management.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Comparative efficacy of anti-vascular endothelial growth factor (VEGF) treatment regimens for neovascular age-related macular degeneration (nAMD): A network meta-analysis (Exhibit Hall: Posterboard# A0314) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4908;
The NMA found no statistically significant differences in any of the evaluable outcomes in any pairwise comparison with RAN Q4W or PRN (comparisons with RAN PRN shown in Figure).Conclusions This NMA suggests that the different regimens evaluated have not resulted in superior vision benefits compared with RAN PRN or Q4W. If confirmed, these results suggest that greater visual acuity improvements may require a different approach to treatment, such as a different drug delivery paradigm or the development of drugs with different or multiple mechanisms of action.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Efficacy of the Treat-and-Extend Regimen in the Management of Neovascular Age-related Macular Degeneration: 6-year Results of the RENO Study (Exhibit Hall: Posterboard# A0308) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4902;
At the final follow-up, 18.8% of eyes had lost ≥15 letters and 26.1% of eyes had gained ≥15 letters.Conclusions The Treat-and-Extend regimen was effective in maintaining visual acuity in patients with nAMD treated with ranibizumab, aflibercept, or bevacizumab for up to 6 years in patients who received a minimum of 6 injections in the first year and a minimum of 3 injections in the follow up years 2 through 6. The initial vision gains seen in the first 5 years of follow-up were not maintained at year 6.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Clinical Practice Patterns Over 2 Years for Neovascular Age-related Macular Degeneration (nAMD) Patients Treated with Anti-Vascular Endothelial Growth Factors (aVEGFs) (Exhibit Hall: Posterboard# A0307) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4901;
Patients in LUCAS received on average 16.0 RAN injections and 18.2 BEV injections over 2 years, while in ATLAS, patients received on average 8.0 AFL injections in the 1st year and 6.5 injections in the 2nd year. The number of injections over 2 years in these studies with T&E protocols was much higher than the average number in our study over 2 years.Conclusions Based on two-year clinical practice data, patients received fewer injections than expected when compared to per-label dosing or prospective T&E clinical trials, which may translate to poorer visual acuity outcomes.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Accurately Identify nAMD Patients with Low Anti-VEGF Treatment Need by Deep Learning (Exhibit Hall: Posterboard# A0304) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4898;
P3
Purpose We sought to identify nAMD patients with low anti-VEGF (aVEGF) treatment (Tx) need in the HARBOR study (NCT00891735) PRN arms utilizing Deep Learning (DL) algorithms.Methods We analyzed study eye OCTs captured during the 3 consecutive monthly loading ranibizumab (RBZ) injections (injs) from PRN arms of HARBOR, and correlated them with patient inj burden during the follow-up phase (3- to 23-month visit)...While this algorithm needs to be validated on other databases and in the real-world setting, it could help physicians/patients understand future Tx burden. It could also stratify patients in future clinical trials assessing aVEGF inj durability.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Real world clinical audit of anti-VEGF Ranibizumab and Aflibercept use in the management of wet age related macular degeneration (Exhibit Hall: Posterboard# A0293) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4887;
Males 81, (35.2%) and 149 (64.8%) females.A report summary of the data at month 12: 75 eyes injected, 56.0% (42) ≥5 letters gain, 36.0% (27) eyes ≥10 letters gain and 25.3% (19) eyes achieved ≥15 letters gain.At 24 months, a total number of 45 eyes injected with 51.1% (23) eyes achieving ≥5 letters gain, 40.0% (18) eyes achieving ≥10 letters gain and 26.7% (12) eyes achieving ≥15 letters gain.At 36 months, a total number of 34 eyes were injected, 38.2% (13) eyes achieving ≥5 letters gain, 29.4% (10)eyes achieving ≥10 letters gain and 11.8% (4) eyes achieving ≥15 letters gain.Conclusions In real world settings, treatment of wet ARMD with Ranibizumab and Aflibercept compares favourably to the landmark clinical trials with idealistic circumstances.At month 12, 16 and 22, our study results of Ranibizumab shows slightly better visual gain compared to Anchor and Marina Trials at the same period. However Aflibercept results shows almost identical results to the landmark Trails throughout the course from month zero to month 24 with slightly better gain at month 22 compared to the same period in Anchor and Marina.The greatest improvement in mean VA was among the group of patients with baseline letter score between 70 to 80 ETDRS, comes 2nd the baseline score between 60 and 70.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Subretinal Fibrosis in nAMD in the Era of Anti-VEGF Treatment (Exhibit Hall: Posterboard# A0290) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4884;
The subretinal fibrosis can present following a nAMD treatment with anti-VEGF, regardless of which one is used and can bring an impact to the patient's life. A treatment for this complication is not yet available.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Treatment Burden and Visual Outcomes in Neovascular Age-Related Macular Degeneration (AMD) (Exhibit Hall: Posterboard# A0286) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4880;
The correlation coefficient between the number of injections and mean change in ETDRS letters is 0.61.Conclusions Despite the varying durability of the different anti-VEGF agents, there is a positive correlation between the number of injections in 12-months and the change in mean BCVA (ETDRS letters). While challenging in practice, frequent treatment regimens have benefits in terms of vision, however, this needs to be mitigated by real-world constraints.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Treatment interval of neovascular age-related macular degeneration before and after macular hole repair (Exhibit Hall: Posterboard# A0285) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4879;
Seven patients were being treated with ranibizumab and one with aflibercept at time of surgery...Two patients stopped receiving injections entirely after surgery due to progression to a disciform scar not responsive to further therapy.Conclusions Based on this preliminary evaluation, it seems that surgical repair of a FTMH does not alter the activity of the choroidal neovascular membrane in NVAMD based on injection frequency. Additionally, the success rate of primary hole closure and VA in those with NVAMD is consistent with prior reports.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Two-year outcomes of patients receiving anti-VEGF treatment for neovascular age-related macular degeneration on a treat-and-extend regimen (Exhibit Hall: Posterboard# A0278) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4872;
Eyes treated with aflibercept had significantly lower drusen volume at 24 months than eyes treated with ranibizumab (0.18 mm3 vs. 0.49 mm3, p = 0.02).Conclusions On a treat-and-extend regimen, treatment of nAMD with aflibercept, bevacizumab or ranibizumab demonstrated comparable BCVA at 24 months. More frequent injections of anti-VEGF led to significantly improved visual acuity and slower growth of GA.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
The Characteristics and Outcomes of Retinal Detachments (RD) in Patients Receiving Intravitreal Injections (IVI). (Exhibit Hall: Posterboard# A0385) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4401;
The mean visual acuity at last follow-up was 20/250.Conclusions While the incidence of RD secondary to IVI is low at 0.014%, we found that 55.6% (5/9) presented with macular-off detachments, leading to poor visual outcomes. The delayed patient consultation could be due to visual impairments from underlying macular disease.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Optimization of the Port Delivery System With Ranibizumab (PDS) Implant Insertion Procedure in the Ladder Phase 2 Trial (Exhibit Hall: Posterboard# A0341) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4356;
P2, P3
Surgery video review showed that adherence to the specified surgical methodology was key to mitigating VH occurrence and other postsurgical events.Conclusions The optimized PDS implant insertion procedure with prophylactic laser ablation of the exposed pars plana before incision and PDS implant insertion reduced the VH rate in the Ladder trial. A robust training plan has been implemented for the ongoing phase 3 Archway trial (NCT03677934) to ensure procedural consistency and maximize surgical outcomes.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Automated quantification of retinal fluid and its impact on treatment outcomes in the FLUID study (Room 314) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4153;
Comparing SRF/IRF volumes in the total central 1mm and 6mm after the first treatment with ranibizumab did not show a significant difference between patients who lost or gained 10 or 15 letters or more (all p>0.05).Conclusions AI-based image analyses provide a reliable tool to assess the quantitative impact of retinal fluid on treatment outcomes and supports patient-oriented decisions in nAMD therapy. By using AI we were able to show that despite this difference in SRF tolerance in the FLUID study, there was no difference in BCVA outcomes.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis, abicipar pegol (AGN-150998) / Allergan, Molecular Partners
Efficacy and Safety of Abicipar for Treatment of Neovascular Age-related Macular Degeneration: Study Design and 2-Year Results from the CEDAR and SEQUOIA Phase 3 Studies (Room 314) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4148;
The incidence of intraocular inflammation AEs was reduced to 0.8%, 2.3%, and 1.0% during year 2 in the abicipar Q8, abicipar Q12, and ranibizumab Q4 arms, respectively, with no new cases of endophthalmitis or retinal vasculitis reported in year 2.Conclusions The CEDAR and SEQUOIA studies are the first phase 3 studies to successfully demonstrate noninferiority of an unadjusted, quarterly anti-VEGF regimen to monthly ranibizumab in stabilizing vision while reducing treatment burden in nAMD. During year 2 of the studies, abicipar Q12 (4 injections) provided and maintained visual and anatomic gains as well as ranibizumab Q4 (12 injections).
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Canadian Treat-and-Extend Trial with Ranibizumab in nAMD Patients: CANTREAT 36 Month Anatomic Outcomes (Room 314) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4147;
Mean (SD) reductions from baseline in CRT at Months 12, 24, and 36 were 111.8 (118.64), 136.0(127.89), and 127.7(131.23) µm in T&E patients, respectively, vs 107.0 (104.88), 113.3 (107.28), and 115.1 (108.33) µm in OM T&E patients.Conclusions After 36 months, mean BCVA improvements achieved at 24 months were maintained for both the patients exclusively treated with the T&E regimen and those that switched to T&E after 24 months of the OM regimen. From baseline to Months 12, 24, and 36, changes in CRT were similar for both treatment arms.
- |||||||||| Avastin (bevacizumab) / Roche, Eylea (aflibercept intravitreal) / Bayer, Regeneron, Lucentis (ranibizumab) / Roche, Novartis
Efficacy and tolerance of Aflibercept intravitreal injection in vitrectomized eyes with diabetic macular edema. (Exhibit Hall: Posterboard# B0159) - Mar 9, 2020 - Abstract #ARVO2020ARVO_3931;
34 eyes were treated previously with thermal laser (28.9%), intravitreal injection of triamcinolone (17%), of ranibizumab (46.8%), of dexamethasone implant (25.5%), or bevacizumab (4.3%)...Mean number of injection was 9.5 and mean interval injection was 5.7 weeks.Conclusions These results suggest that IAI may be beneficial in functional and anatomical outcome in vitrectomized eyes with diabetic macular edema. Vitrectomized eyes had characteristic of refractory persistent diabetic macular edema, requiring frequent injections.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Optimization and characterization of bispecific aptamers targeting both VEGF and Angiopoietin-2 for treating retinal diseases (Exhibit Hall: Posterboard# B0156) - Mar 9, 2020 - Abstract #ARVO2020ARVO_3928;
By increasing the hydrodynamic radius and slowing down diffusion, the pegylation imparts an estimated 2-fold improvement in vitreal half-life.Conclusions We optimized our VEGF/Ang2 bispecific aptamer to potentially enable better efficacy and longer duration in treating retinal diseases. We plan to advance the program to the Investigational New Drug (IND) application to evaluate its clinical utility.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Longitudinal Assessment of Intraocular Cytokine Expression in Retinal Venous Occlusive Disease Following Anti-VEGF Therapy (Exhibit Hall: Posterboard# B0152) - Mar 9, 2020 - Abstract #ARVO2020ARVO_3924;
The WAVE study was a prospective randomized trial evaluating ranibizumab monotherapy versus a combination ranibizumab and targeted retinal photocoagulation (TRP) to nonperfusion in 30 eyes with central, hemi- or branch retinal vein occlusions (CRVO, HRVO, BRVO)...Multi-modal therapy resulted in greater reduction in VEGF burden. Future research will include correlation of imaging features with underlying cytokine expression for the exploratory assessment of imaging biomarkers.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Progression and response predictive factors of diabetic macular edema in patients treated with intravitreal therapy (Exhibit Hall: Posterboard# B0150) - Mar 9, 2020 - Abstract #ARVO2020ARVO_3922;
Purpose To study the safety and efficacy of PRN (pro re nata) ranibizumab in patients with naive DME (diabetic macular edema) in clinical practice in the Ophthalmology department of the HCUV (Hospital Clínico Universitario de Valladolid) and to study the relationship between diabetes’s systemic management, OCT (optical coherence tomography) biomarkers and patient’s evolution, in order to establish factors that may predict the response to treatment.Methods Retrospective transversal study from patient records from patients under treatment with ranibizumab and PRN pattern in 2017 and their OCT images...Patients with higher initial macular volume and higher CMT had better anatomical evolution after treatment. Alternatives for treatment and follow-up should be considered as injections and visits are below recommended values.
- |||||||||| Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Does switching from intravitreal anti-VEGF to corticosteroids improve outcomes in diabetic macular edema (DME)? (Exhibit Hall: Posterboard# B0148) - Mar 9, 2020 - Abstract #ARVO2020ARVO_3920;
This reflects previous reports and suggests that, by the time a decision to switch therapy is made, permanent structural damage to the retina may already have occurred. Identifying patients who would respond to corticosteroid therapy earlier in their treatment may be of value and enable improved functional results to mirror the anatomical results seen in our study.
- |||||||||| Lucentis (ranibizumab) / Roche, Novartis
Significance of External Limiting Membrane Integrity as an OCT Biomarker on Functional Outcomes in Eyes with Macular Edema (Exhibit Hall: Posterboard# A0349) - Mar 9, 2020 - Abstract #ARVO2020ARVO_3871;
Purpose To investigate effect of foveal external limiting membrane (ELM) disruption detected using Optical Coherence Tomography (OCT) on visual outcomes of eyes with resolved macular edema.Methods Patients with macular edema were randomized 1:1 to receive 0.5 or 2.0 mg of monthly IVT ranibizumab until month 6, followed by PRN dosing (READ-3 Study)...Patients with intact ELM after resolution of macular edema appear to gain more vision compared to patients with disruption of the ELM. Assessment of ELM integrity after treatment may correlate with functional response to therapy in patients with diabetic macular edema.
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