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  • Kaiser, Peter K
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  • 1
    Language: English
    In: Immunotherapy, February 2013, Vol.5(2), pp.121-30
    Description: Neovascular age-related macular degeneration (AMD) is the leading cause of legal blindness in patients over the age of 50 in the western world. Intravitreally administered anti-VEGF drugs have been developed to halt neovascular growth in AMD. Randomized trials have demonstrated the excellent safety profile and significant benefit of anti-VEGF therapy in maintaining vision. Aflibercept (Eylea(®); Regeneron, NY, USA) is a soluble decoy receptor against VEGF that offers greater potency and binding affinity than other anti-VEGF drugs. Having received US FDA approval for neovascular AMD in November 2011, aflibercept given every 8 weeks after a loading dose was 'clinically equivalent' and statistically noninferior to the current FDA-approved therapy ranibizumab (Lucentis(®); Genentech, CA, USA), given every 4 weeks. This article discusses the clinical background of AMD, development of aflibercept, results of the clinical trials and the future role of aflibercept in ocular neovascular diseases.
    Keywords: Macular Degeneration -- Drug Therapy ; Neovascularization, Pathologic -- Drug Therapy ; Receptors, Vascular Endothelial Growth Factor -- Therapeutic Use ; Recombinant Fusion Proteins -- Therapeutic Use
    ISSN: 1750743X
    E-ISSN: 1750-7448
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  • 2
    Language: English
    In: American Journal of Ophthalmology, August 2012, Vol.154(2), pp.222-226
    Description: To describe the pharmacokinetics, preclinical studies, and clinical trials of the newly approved anti–vascular endothelial growth factor (VEGF) drug aflibercept (Eylea (VEGF Trap-Eye); Regeneron; and Bayer). Review with editorial commentary. A review of the medical literature and pertinent Internet postings combined with analysis of key studies with expert opinion regarding the use of aflibercept for the treatment of exudative age-related macular degeneration. Aflibercept, a fusion protein with binding domains from native VEGF receptors, binds VEGF-A, VEGF-B, and placental growth factors 1 and 2 with high affinity. Preclinical ophthalmologic studies demonstrated that aflibercept suppresses choroidal neovascularization in several animal models. The results of phase 1 and 2 trials showed excellent short-term suppression of choroidal neovascularization in patients with exudative age-related macular degeneration and suggested a longer durability of aflibercept compared with other anti-VEGF drugs. The pivotal phase 3 Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration 1 and 2 trials showed that monthly and bimonthly aflibercept were noninferior to monthly ranibizumab at preventing vision loss (〈 15-letter loss) with comparable vision gains and safety. Year 2 treatment involved monthly pro re nata injections with required injections every 3 months and maintained vision gains from the first year, with an average of 4.2 injections of aflibercept and 4.7 injections of ranibizumab. Aflibercept promises to deliver excellent visual outcomes for exudative age-related macular degeneration patients while undergoing fewer injections compared with ranibizumab. With a wholesale cost of $1850 per dose, the cost per patient with aflibercept treatment promises to be lower than with ranibizumab.
    Keywords: Medicine
    ISSN: 0002-9394
    E-ISSN: 1879-1891
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  • 3
    Language: English
    In: Ophthalmology, May 2012, Vol.119(5), pp.1001-1010
    Description: To demonstrate noninferiority of ranibizumab in combination with verteporfin photodynamic therapy (PDT) versus ranibizumab monotherapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). Prospective, multicenter, double-masked, randomized, phase IIIb clinical trial. Three hundred twenty-one patients randomized to receive either ranibizumab 0.5 mg monotherapy (n = 112), standard fluence (SF) verteporfin PDT combination therapy (n = 104), or reduced fluence (RF) verteporfin PDT combination therapy (n = 105). Ranibizumab was administered monthly in the monotherapy group. In both combination therapy groups, ranibizumab was initiated with 3 consecutive monthly injections, followed by retreatment as needed ( ) with monthly monitoring. All patients were evaluated monthly for 12 months. Mean change in best-corrected visual acuity (BCVA) from baseline at month 12 and proportion of patients randomized to either combination therapy with a ranibizumab treatment-free interval of 3 months or longer. Two hundred eighty-six patients (89.1%) completed the 12-month study. Mean BCVA change at month 12 was +5.3 and +4.4 letters with verteporfin SF (n = 103) or verteporfin RF (n = 105) plus ranibizumab, respectively, compared with +8.1 letters with ranibizumab monotherapy (n = 110; adjusted 97.5% confidence interval [CI], (−7.90 to infinity); = 0.0666; and 97.5% CI, (−8.51 to infinity); = 0.1178; for combination regimens vs. monotherapy, respectively). Noninferiority of either combination regimen to monthly ranibizumab monotherapy was not demonstrated (primary end point). A ranibizumab treatment-free interval of 3 months or longer was achieved in 92.6% and 83.5% of the patients randomized to verteporfin SF or verteporfin RF groups, respectively, with a mean of 5.1 and 5.7 ranibizumab injections, respectively, and patients in the ranibizumab monotherapy arm received 10.5 injections. At month 12, mean central retinal thickness decreased by 151.7 μm and 140.9 μm for the verteporfin SF and RF groups, respectively, and by 172.2 μm with ranibizumab monotherapy. Safety and tolerability of all 3 regimens were similar to and consistent with previous studies in neovascular AMD. The number of ocular serious adverse events was low and occurred largely as single cases. Ranibizumab monotherapy or combined with verteporfin PDT improved BCVA at month 12; however, noninferiority (7-letter margin) of combination regimens to ranibizumab monotherapy was not demonstrated. Verteporfin RF did not confer clinical benefits over verteporfin SF. All treatments were well tolerated. Proprietary or commercial disclosure may be found after the references.
    Keywords: Medicine
    ISSN: 0161-6420
    E-ISSN: 1549-4713
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  • 4
    In: The New England Journal of Medicine, 2006, Vol.355(14), pp.1419-1431
    Description: Background Ranibizumab — a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A — has been evaluated for the treatment of neovascular age-related macular degeneration. Methods In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. Results We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P〈0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P〈0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P〈0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. Conclusions Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 .) Previous studies have suggested that targeting intravitreal vascular endothelial growth factor A (VEGF-A) counters choroidal neovascularization and hence age-related macular degeneration. A double-blind, placebo-controlled trial of ranibizumab, which neutralizes all isoforms of VEGF-A, for treatment of minimally classic and occult age-related macular degeneration retarded the progression of the disease and improved visual acuity in some patients. For the treatment of minimally classic and occult age-related macular degeneration, ranibizumab retarded the progression of the disease and improved visual acuity in some patients. Age-related macular degeneration is a leading cause of irreversible blindness among people who are 50 years of age or older in the developed world.1–3 The neovascular form of the disease usually causes severe vision loss and is characterized by the abnormal growth of new blood vessels under or within the macula, the central portion of the retina responsible for high-resolution vision. Neovascularization in this disease is classified by fluorescein angiography into major angiographic patterns termed classic and occult, which may be associated with various degrees of aggressiveness of disease, vision loss, and response to various treatment options.4 Pharmacologic therapies . . .
    Keywords: Medicine;
    ISSN: 0028-4793
    E-ISSN: 1533-4406
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  • 5
    In: The New England Journal of Medicine, 2006, Vol.355(14), pp.1432-1444
    Description: Background We compared ranibizumab — a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A — with photodynamic therapy with verteporfin in the treatment of predominantly classic neovascular age-related macular degeneration. Methods During the first year of this 2-year, multicenter, double-blind study, we randomly assigned patients in a 1:1:1 ratio to receive monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin therapy or monthly sham injections plus active verteporfin therapy. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. Results Of the 423 patients enrolled, 94.3% of those given 0.3 mg of ranibizumab and 96.4% of those given 0.5 mg lost fewer than 15 letters, as compared with 64.3% of those in the verteporfin group (P〈0.001 for each comparison). Visual acuity improved by 15 letters or more in 35.7% of the 0.3-mg group and 40.3% of the 0.5-mg group, as compared with 5.6% of the verteporfin group (P〈0.001 for each comparison). Mean visual acuity increased by 8.5 letters in the 0.3-mg group and 11.3 letters in the 0.5-mg group, as compared with a decrease of 9.5 letters in the verteporfin group (P〈0.001 for each comparison). Among 140 patients treated with 0.5 mg of ranibizumab, presumed endophthalmitis occurred in 2 patients (1.4%) and serious uveitis in 1 (0.7%). Conclusions Ranibizumab was superior to verteporfin as intravitreal treatment of predominantly classic neovascular age-related macular degeneration, with low rates of serious ocular adverse events. Treatment improved visual acuity on average at 1 year. (ClinicalTrials.gov number, NCT00061594 .) Previous studies have implicated intravitreal vascular endothelial growth factor A (VEGF-A) as a target for countering neovascularization and, therefore, age-related macular degeneration. This double-blind, controlled trial comparing ranibizumab, which neutralizes all isoforms of VEGF-A, with photodynamic therapy with verteporfin showed that ranibizumab was better able to retard the progression of predominantly classic neovascular age-related macular degeneration. This trial comparing ranibizumab with photodynamic therapy with verteporfin showed that ranibizumab was better able to retard the progression of predominantly classic neovascular age-related macular degeneration. Age-related macular degeneration is a leading cause of severe and irreversible vision loss in the developed world among people 50 years of age or older.1–4 The neovascular form of the disease is characterized by the growth of abnormal, choroidal blood vessels beneath the macula, which causes severe loss of vision.5 Two main patterns of choroidal neovascularization that are associated with age-related macular degeneration, as seen on fluorescein angiography, are classic (in which intensely bright fluorescence is seen in early phases of the angiogram and leaks in late phases) and occult (in which leakage is less intense and appears in . . .
    Keywords: Medicine;
    ISSN: 0028-4793
    E-ISSN: 1533-4406
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  • 6
    Language: English
    In: Ophthalmology, 2009, Vol.116(1), pp.57-65.e5
    Description: The 2-year, phase III trial designated -vascular endothelial growth factor (VEGF) Antibody for the Treatment of Predominantly Classic oidal Neovascularization (CNV) in Age-related Macular Degeneration (ANCHOR) compared ranibizumab with verteporfin photodynamic therapy (PDT) in treating predominantly classic CNV. Multicenter, international, randomized, double-masked, active-treatment-controlled clinical trial. Patients with predominantly classic, subfoveal CNV not previously treated with PDT or antiangiogenic drugs. Patients were randomized 1:1:1 to verteporfin PDT plus monthly sham intraocular injection or to sham verteporfin PDT plus monthly intravitreal ranibizumab (0.3 mg or 0.5 mg) injection. The need for PDT (active or sham) retreatment was evaluated every 3 months using fluorescein angiography (FA). The primary, intent-to-treat efficacy analysis was at 12 months, with continued measurements to month 24. Key measures included the percentage losing 〈15 letters from baseline visual acuity (VA) score (month 12 primary efficacy outcome measure), percentage gaining ≥15 letters from baseline, and mean change over time in VA score and FA-assessed lesion characteristics. Adverse events were monitored. Of 423 patients (143 PDT, 140 each in the 2 ranibizumab groups), the majority (≥77% in each group) completed the 2-year study. Consistent with results at month 12, at month 24 the VA benefit from ranibizumab was statistically significant ( 〈0.0001 vs. PDT) and clinically meaningful: 89.9% to 90.0% of ranibizumab-treated patients had lost 〈15 letters from baseline (vs. 65.7% of PDT patients); 34% to 41.0% had gained ≥15 letters (vs. 6.3% of PDT group); and, on average, VA was improved from baseline by 8.1 to 10.7 letters (vs. a mean decline of 9.8 letters in PDT group). Changes in lesion anatomic characteristics on FA also favored ranibizumab (all comparisons 〈0.0001 vs. PDT). Overall, there was no imbalance among groups in rates of serious ocular and nonocular adverse events. In the pooled ranibizumab groups, 3 of 277 (1.1%) patients developed presumed endophthalmitis in the study eye (rate per injection = 3/5921 [0.05%]). In this 2-year study, ranibizumab provided greater clinical benefit than verteporfin PDT in patients with age-related macular degeneration with new-onset, predominantly classic CNV. Rates of serious adverse events were low. Proprietary or commercial disclosure may be found after the references.
    Keywords: Medicine
    ISSN: 0161-6420
    E-ISSN: 1549-4713
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  • 7
    Language: English
    In: JAMA ophthalmology, 01 March 2017, Vol.135(3), pp.291
    Keywords: Bevacizumab ; Macular Edema
    ISSN: 21686165
    E-ISSN: 2168-6173
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  • 8
    Language: English
    In: European Journal of Opthalmology, May 2011, Vol.21(3), pp.271-275
    Description: Purpose TO report the optical coherence tomographic features differentiating choroidal nevus from choroidal melanoma by 3D spectral-domain optical coherence tomography (SD-OCT) and OCT characteristics of other choroidal tumors. Methods A total of 67 consecutive eyes with choroidal tumors including choroidal nevus (25 eyes), indeterminate choroidal melanocytic lesion (11 eyes), malignant melanoma (23 eyes), metastasis (4 eyes), hemangioma (2 eyes), and osteoma (2 eyes) were imaged with 3D SD-OCT (OCT-1000; Topcon Inc., Paramus, NJ). The images were analyzed for the presence or absence of SD-OCT findings such as retinal pigment epithelium (RPE)/choriocapillaris reflectivity, RPE irregularity, drusen, sub-RPE fluid, RPE thickness, subretinal deposit, subretinal fluid, intraretinal edema, retinal thickness, and photoreceptor inner and outer segment junction (IS/OS). Visualization of the choroidal tumor and its intrinsic reflectivity OCT features were also assessed. Results When compared with nevus, subretinal deposit, subretinal fluid, and intraretinal edema were detected significantly more frequently in the eyes with malignant melanoma (p〈0.001). SD-OCT visualization of the tumor was limited only to the anterior aspect. Choroidal nevus, indeterminate lesions, melanoma, and metastatic lesions had variable intrinsic reflectivity pattern. Intrinsic features of hemangioma included choroidal hollowness whereas osteoma demonstrated high intrinsic reflectivity. Conclusions SD-OCT provides useful information to observe and document the retinal and RPE changes secondary to choroidal tumors that help differentiate choroidal nevus from malignant melanoma. Improvements in the current OCT systems are needed to better characterize intrinsic features of choroidal tumors.
    Keywords: Choroidal Nevus ; Choroidal Tumor ; Hemangioma ; Malignant Melanoma ; Osteoma ; Spectral-Domain Optical Coherence Tomography ; Medicine
    ISSN: 1120-6721
    E-ISSN: 1724-6016
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  • 9
    Language: English
    In: British Journal of Ophthalmology, 23 January 2013, Vol.97(1), p.66
    Description: To describe the choroidal characteristics of patients with retinitis pigmentosa (RP) using enhanced depth imaging (EDI) and spectral domain (SD) optical coherence tomography (OCT).
    Keywords: Retina ; Genetics
    ISSN: 0007-1161
    ISSN: 00071161
    E-ISSN: 1468-2079
    E-ISSN: 14682079
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  • 10
    In: Retina, 2014, Vol.34(2), pp.213-221
    Description: PURPOSE:: To evaluate the intrasurgical retinal architectural and macular hole (MH) geometric alterations that occur during surgical MH repair using intraoperative optical coherence tomography. METHODS:: A retrospective, multisurgeon, single-center, consecutive case series of 21 eyes undergoing surgical repair for MH with concurrent intraoperative optical coherence tomography using a custom microscope–mounted optical coherence tomography system was performed. All patients underwent surgical repair with pars plana vitrectomy, membrane peel, and gas tamponade. A novel three-dimensional segmentation algorithm was used for volumetric analysis of intrasurgical changes of MH geometry after surgical repair. Intraoperative optical coherence tomographic characteristics analyzed included MH volume, minimum diameter, base area, and hole height. Outer retinal architecture changes were analyzed both quantitatively and qualitatively. RESULTS:: All 21 eyes were successfully imaged with intraoperative optical coherence tomography. Nineteen of 21 eyes had images of sufficient signal strength to allow for quantitative analysis. Significant changes were noted in MH geometry after internal limiting membrane peeling including increased MH volume, increased base area, and decreased top area (all P 〈 0.03). Additionally, increased subretinal hyporeflectance was noted by expansion of the height between the inner segment/outer segment and retinal pigment epithelium bands (P = 0.008). Peeling methods and surgeon experience did not correlate with the magnitude of architectural alterations. Macular hole algorithm measurements and alterations were associated with visual outcome and MH closure. CONCLUSION:: Significant alterations occur in MH geometry and outer retinal structure after internal limiting membrane peeling. These changes are subclinical and unable to be appreciated with en face surgical microscope viewing and require intraoperative optical coherence tomography for visualization. Preliminary analysis of these measurements identified an association with visual outcome and successful MH closure. The functional significance of these changes deserves further study.
    Keywords: Medicine;
    ISSN: 0275-004X
    E-ISSN: 15392864
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