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Purpose: To assess the awareness of biosimilar intravitreal anti-VEGF agents among retina specialists practicing in the United States (US) and Europe., Methods: A 16-question online survey was created in English and distributed between Dec 01, 2021 and Jan 31, 2022. A total of 112 respondents (retinal physicians) from the US and Europe participated., Results: The majority of the physicians (56.3%) were familiar with anti-VEGF biosimilars. A significant number of physicians needed more information (18.75%) and real world data (25%) before switching to a biosimilar. About one half of the physicians were concerned about biosimilar safety (50%), efficacy (58.9 %), immunogenicity (50%), and their efficacy with extrapolated indications (67.8 %). Retinal physicians from the US were less inclined to shift from off-label bevacizumab to biosimilar ranibizumab or on-label bevacizumab (if approved) compared to physicians from Europe (p=0.0001). Furthermore, physicians from the US were more concerned about biosimilar safety (p=0.0371) and efficacy compared to Europe (p= 0.0078)., Conclusions: The Bio-USER survey revealed that while the majority of retinal physicians need additional information regarding the safety, efficacy and immunogenicity when making clinical decisions regarding their use. Retinal physicians from US are more comfortable in continuing to use off-label bevacizumab compared to physicians from Europe.

Purpose: To report spectral-domain optical coherence tomography (SD-OCT) features in patients diagnosed with Susacs syndrome., Methods: Clinical report of two cases., Results: Spectral-domain optical coherence tomography was performed in two patients diagnosed with Susacs syndrome. Both the patients had normal macular perfusion on fluorescein angiography (FA). However, SD-OCT revealed bilateral, temporal macular atrophy with disorganization and thinning of the retinal layers. The outer plexiform layer showed nodularity and waviness suggestive of ischemic swelling of the bipolar cells., Conclusion: Retinal structural changes in Susacs syndrome have not been described earlier. Spectral-domain optical coherence tomography may be more sensitive than fluorescein angiography in detecting microstructural retinal alterations in various layers, especially in apparently perfused retina. These findings may provide an insight into the pathogenesis of Susacs syndrome.

Purpose: To assess the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with diabetic macular edema (DME)., Design: Retrospective cohort study., Participants: Data from patients enrolled in the Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 with High Dose (READ-3) study were analyzed., Methods: In the READ-3 study, patients with DME received monthly intravitreal injections of either 0.5 or 2.0 mg ranibizumab. Optical coherence tomography images from patients who completed the month 6 visit of the study were analyzed at the baseline visit to identify the presence (VMA+) or absence (VMA-) of VMA. Patients with any degree of vitreomacular traction were excluded from the analysis. Two independent graders graded all images. Vitreomacular adhesion was classified by size of adhesion into either focal (<1500 μm) or broad (≥1500 μm)., Main Outcome Measures: Mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) at month 6 and incidence of posterior vitreous detachment (PVD)., Results: One hundred fifty-two eyes (152 patients) were randomized in the READ-3 study. One hundred twenty-four eyes (124 patients) were eligible for the study based on study criteria. Twenty-eight eyes did not meet study criteria and were excluded from the study. At baseline, 26 patients were classified as VMA+ and 98 patients were classified as VMA-. The distribution of the 2 doses of ranibizumab (0.5 and 2.0 mg) in the 2 groups was similar. At month 6, the mean improvement in BCVA was 11.31±6.67 and 6.86±7.58 letters in the VMA+ and VMA- groups, respectively (P = 0.007). Mean improvement in CRT was -173.81±132.31 and -161.84±131.34 μm in the VMA+ and VMA- groups, respectively (P = 0.681). At month 6, among the 26 VMA+ eyes (at baseline), 7 eyes demonstrated PVD, 17 eyes showed no change in VMA status, and 2 eyes were not gradable and were excluded., Conclusions: Diabetic macular edema patients with VMA have a greater potential for improvement in visual outcomes with anti-vascular endothelial growth factor therapy. Therefore, the presence of VMA should not preclude patients with DME from receiving treatment., (Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Vascular diseases of the retina such as diabetic retinopathy and vascular occlusions account for a large proportion of visual morbidity and blindness worldwide. The role of vitreous in the pathogenesis of these conditions has been increasingly recognized. Despite advances in the surgical technique of pars plana vitrectomy, the use of intravitreal agents for the lysis of vitreous has received attention, guided largely by promising results from the trials involving patients with non-vascular retinal diseases such as vitreomacular traction. The purpose of this review is to provide a comprehensive summary of the present knowledge on pathophysiologic basis of pharmacologic vitreolysis and its efficacy in vascular diseases of the retina. A review of completed and ongoing clinical trials will be presented, along with insights into future directions of this therapy., (Copyright 2016, SLACK Incorporated.)

Vascular endothelial growth factor (VEGF) inhibitors currently used to treat eye diseases have included monoclonal antibodies, antibody fragments, and an aptamer. A different method of achieving VEGF blockade in retinal diseases includes the concept of a cytokine trap. Cytokine traps are being evaluated for the treatment of various diseases that are driven by excessive cytokine levels. Traps, such as VEGF Trap, consist of two extracellular cytokine receptor domains fused together to form a human IgG. Aflibercept (VEGF Trap-Eye) is a soluble fusion protein which combines ligand-binding elements taken from the extracellular components of VEGF receptor (VEGFR)-1 and VEGFR-2 fused to the Fc portion of IgG. This protein contains all human amino-acid sequences, which minimizes the potential for immunogenicity in human patients. The chapter will summarize the chemical properties of aflibercept and the various studies that have demonstrated a role of aflibercept in the management of retinal vascular diseases such as neovascular age-related macular degeneration, diabetic retinopathy, macular edema, and retinal vein occlusion., (© 2016 S. Karger AG, Basel.)

Chronic inflammation plays an important role in the pathogenesis of ocular diseases such as diabetic retinopathy, uveitis and age-related macular degeneration. Activation and proliferation of naïve T cells may result in pathological changes responsible for significant visual morbidity. Sirolimus (earlier termed rapamycin) is a novel drug that inhibits cellular kinases and, thereby, inhibits T-cell proliferation. Preclinical studies in experimental models have shown promising results with the use of this pharmacological agent in various ocular conditions. Subsequently, early phase I/II studies have provided encouraging safety and efficacy data. This chapter focuses on the mechanisms of action, preclinical study results and data from human clinical trials of sirolimus in human eye diseases. Key highlights from ongoing phase III clinical trials are also provided. Sirolimus, thus, appears to be an important addition to the armamentarium of steroid-sparing therapeutic agents that act on various steps in the inflammatory pathway., (© 2016 S. Karger AG, Basel.)

Purpose: To evaluate changes in macular sensitivity, as measured with microperimetry, among patients with maculopathy and stable visual acuity (VA)., Methods: Macular sensitivity was assessed using the Spectral OCT/SLO™ microperimetry (OCT/SLO, Optos Plc., Dunfermline, UK) in 25 eyes (16 patients) with maculopathy and stable VA (<5 letters change in ETDRS score) at two consecutive clinic visits. To take the limits of the test-retest repeatability of the OCT/SLO into account, coefficient of repeatability (CoR) was employed to estimate the probability of the sensitivity changes being secondary to measurement noise., Results: The point sensitivity changes were statistically significant (Wilcoxon signed-rank test, P < 0.001). Seventy-seven points (11 %) out of a total of 700 sensitivity points had a genuine sensitivity change, with a mean increase of 8.6 ± 2.6 dB in 35 points and a mean decrease of 7.9 ± 2.2 dB in 42 points., Conclusions: Point-to-point change in macular sensitivity can be used as a biomarker of changes in disease activity in patients with maculopathy, and can be more accurate than either mean sensitivity or BCVA in detection of changes in macular function. The measurement variability should be considered when observing the local sensitivity changes.

Subretinal perfluorocarbon liquid (PFCL) is a rare but serious complication associated with retinal detachment repair primarily due to the potential for toxic effects of the liquid on various structures of the eye. While it is optimal to detect and remove subretinal PFCL intraoperatively, retained PFCL may be missed in 1% to 11% of cases and not detected until follow-up visits.3,26 In such cases, early intervention appears to be warranted particularly if central vision remains at risk with subfoveally located droplets. Restoration of the foveal contour and attenuation of scotoma size as indicated by optical coherence tomography and microperimetry imaging suggest a good prognosis based on the limited number of case reports reviewed. Prognosis of retained PFCL depends on the location, size, and duration of its contact with retinal structures., (Copyright 2013, SLACK Incorporated.)

Optical coherence tomography studies in multiple sclerosis have primarily focused on evaluation of the retinal nerve fibre layer. The aetiology of retinal changes in multiple sclerosis is thought to be secondary to optic nerve demyelination. The objective of this study was to use optical coherence tomography to determine if a subset of patients with multiple sclerosis exhibit primary retinal neuronopathy, in the absence of retrograde degeneration of the retinal nerve fibre layer and to ascertain if such patients may have any distinguishing clinical characteristics. We identified 50 patients with multiple sclerosis with predominantly macular thinning (normal retinal nerve fibre-layer thickness with average macular thickness < 5th percentile), a previously undescribed optical coherence tomography defined phenotype in multiple sclerosis, and compared them with 48 patients with multiple sclerosis with normal optical coherence tomography findings, 48 patients with multiple sclerosis with abnormal optical coherence tomography findings (typical for multiple sclerosis) and 86 healthy controls. Utilizing a novel retinal segmentation protocol, we found that those with predominant macular thinning had significant thinning of both the inner and outer nuclear layers, when compared with other patients with multiple sclerosis (P < 0.001 for both), with relative sparing of the ganglion cell layer. Inner and outer nuclear layer thicknesses in patients with non-macular thinning predominant multiple sclerosis were not different from healthy controls. Segmentation analyses thereby demonstrated extensive deeper disruption of retinal architecture in this subtype than may be expected due to retrograde degeneration from either typical clinical or sub-clinical optic neuropathy. Functional corroboration of retinal dysfunction was provided through multi-focal electroretinography in a subset of such patients. These findings support the possibility of primary retinal pathology in a subset of patients with multiple sclerosis. Multiple sclerosis-severity scores were also significantly increased in patients with the macular thinning predominant phenotype, compared with those without this phenotype (n = 96, P=0.006). We have identified a unique subset of patients with multiple sclerosis in whom there appears to be disproportionate thinning of the inner and outer nuclear layers, which may be occurring as a primary process independent of optic nerve pathology. In vivo analyses of retinal layers in multiple sclerosis have not been previously performed, and structural demonstration of pathology in the deeper retinal layers, such as the outer nuclear layer, has not been previously described in multiple sclerosis. Patients with inner and outer nuclear layer pathology have more rapid disability progression and thus retinal neuronal pathology may be a harbinger of a more aggressive form of multiple sclerosis.

Purpose: To investigate the safety, tolerability, and bioactivity of intravenous infusions of bevacizumab in patients with choroidal neovascularization (CNV) attributable to causes other than age-related macular degeneration., Design: Nonrandomized clinical trial., Methods: Ten patients with CNV received infusions of 5 mg/kg of bevacizumab. The primary efficacy outcome measure was change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study letters read at 4 meters) at 24 weeks and secondary measures were changes from baseline in excess foveal thickness (center subfield thickness), area of fluorescein leakage, and area of CNV., Results: Infusions were well tolerated and there were no ocular or systemic adverse events. At baseline, median VA was 25.5 letters read at 4 meters (20/80) and median foveal thickness was 346 mum. At the primary endpoint (24 weeks), median VA was 48.5 letters (20/32), representing four lines of improvement from baseline (P = .005), median foveal thickness was 248 mum representing a 72% reduction in excess foveal thickness (P = .007). Four of nine patients had complete elimination of fluorescein leakage, three had near complete elimination (reductions of 91%, 88%, and 87%), two had modest reductions, and one had no reduction. All patients except one showed a reduction in area of CNV with a median reduction of 43%., Conclusions: Despite the small number of patients studied, the marked improvement in VA accompanied by prominent reductions in foveal thickness, fluorescein leakage, and area of CNV suggest a beneficial effect. It may be worthwhile to consider further evaluation of systemic bevacizumab in young patients with CNV.

Purpose: To report two cases of syphilis masquerading as chronic refractory macular diseases. Case descriptions: Two patients had been diagnosed with neovascular age-related macular degeneration (neovascular AMD) and diabetic macular edema (DME), respectively. The disease worsened despite repeated intravitreal injections of anti-vascular endothelial growth factor (VEGF) and also surgical treatment (in suspected case of DME). Systemic evaluations were positive for syphilis. Intravenous penicillin was started, and the macular diseases improved. The lesions were well controlled afterward. Conclusions: The current two cases demonstrated that ocular syphilis can masquerade as refractory chronic retinal diseases such as DME and neovascular AMD. Laboratory evaluations for syphilis may be needed, not only for uveitis but also for refractory retinal diseases. Indocyanine green angiography may be helpful to reveal occult syphilis. [ABSTRACT FROM AUTHOR]

Retinal vasculitis presents with inflammation involving the retinal vasculature as an isolated disease or in combination with other ocular or systemic conditions. This entity may be associated with a wide variety of clinical manifestations such as vascular sheathing, cotton-wool spots, retinal ischemia, and neovascularization. Often, retinal vasculitis and its complications lead to diagnostic challenges in identifying the exact etiology of the inflammation. Ancillary investigations such as fundus photography, fluorescein angiography, and more recently, adaptive optics imaging and optical coherence tomography angiography, may provide valuable information that help in establishing the exact diagnosis and initiation of appropriate therapy. In the index review, multimodal imaging features of retinal vasculitis are described. In addition, detection of vascular inflammation using novel noncontact imaging techniques has been highlighted. [ABSTRACT FROM PUBLISHER]

Purpose: The purpose of the study was to report the ability of high-resolution ultrasonography (USG) B-Scan in differentiating between acquired retinoschisis (RS) and retinal detachment (RD), and to compare the findings with spectral-domain optical coherence tomography (SD-OCT). Methods: Patients with acquired peripheral RS and RD undergoing imaging with high-resolution B-scan USG and SD-OCT were included in the study. Descriptive analysis was performed on the images obtained by high-resolution B-scan USG to identify various retinal interfaces. The findings were correlated with those obtained using the SD-OCT images. Results: Six eyes of five patients (two males) with RS and seven eyes of four patients (three males) with RD were included in the study. In all eyes of patients with RS, the outer retina demonstrated the presence of two hyper-reflective lines corresponding to the interfaces of the outer plexiform layer (OPL) and the retinal pigment epithelium (OPL). Eyes diagnosed with RD demonstrated two hyper-reflective lines in the detached portion, corresponding to the nerve fiber layer and OPL interfaces, whereas the attached portion demonstrated the presence of the third hyper-reflective interface, i.e., RPE. These findings correlated well with SD-OCT. Conclusions: Analysis of retinal interfaces on high-resolution USG B-scan may allow precise differentiation of acquired RS from RD by identification of various retinal layers. These findings correlate well with SD-OCT. [ABSTRACT FROM AUTHOR]

Fundus fluorescein angiography (FFA) is a standard screening and diagnosis technique for several retinal diseases. The analysis of FFA images is performed qualitatively by skilled observers, and thus is vulnerable to inter‐ and intra‐observer variability. In this study, the authors present a method for computer‐aided analysis of FFA images. The method is based on generating quantitative colour fluorescein leakage maps (FLM) that mimic the thickness maps generated by the optical coherence tomography (OCT). Results from 64 patients show strong correlation between the FLM and OCT thickness maps (r = 0.8). The method was found to be reproducible and robust to variability in the image acquisition times. [ABSTRACT FROM AUTHOR]

Purpose: To determine bioactivity and duration of effect of intravitreal aflibercept injection (also known as vascular endothelial growth factor Trap-Eye) for neovascular age-related macular degeneration (AMD). Methods: In this double-masked, phase 1 study, 28 patients with lesions ≤12 disc areas, ≥50% active choroidal neovascularization (CNV), and best corrected visual acuity (BCVA) ≤20/40 were randomized 1:1 to a single intravitreal injection of aflibercept 0.15 or 4 mg. The primary end point was the change from baseline in central retinal/lesion thickness (CR/LT) at week-8. Secondary outcomes were the change from baseline BCVA, the change in CNV lesion size and area of leakage, and proportion of patients requiring repeat injection at 8 weeks. Results: Mean percent decrease in CR/LT for the 4-mg and 0.15-mg groups was, respectively, 34.2 versus 13.3 at week 4 ( P=0.0065), 23.8 versus 5.9 at week 6 ( P=0.0380), and 25.2% versus 11.3% at week 8 ( P=0.150). The 4-mg group gained a mean of 4.5 letters in BCVA (6/14 patients gaining ≥10 letters) versus 1.1 letters in 0.15-mg group (1/14 gaining ≥10 letters) at week 8. Fewer patients needed retreatment in the 4-mg group at week 8. No serious adverse event or ocular inflammation was reported in either group. Conclusions: Intravitreal aflibercept 4 mg had a safety profile similar to that of the very low dose 0.15 mg, and was well-tolerated. The 4-mg dose significantly reduced foveal thickening at weeks 4 and 6, significantly improved BCVA at weeks 6, and reduced the need for repeat injection after 8 weeks compared with intravitreal aflibercept 0.15 mg in neovascular AMD patients. [ABSTRACT FROM AUTHOR]

Optical coherence tomography studies in multiple sclerosis have primarily focused on evaluation of the retinal nerve fibre layer. The aetiology of retinal changes in multiple sclerosis is thought to be secondary to optic nerve demyelination. The objective of this study was to use optical coherence tomography to determine if a subset of patients with multiple sclerosis exhibit primary retinal neuronopathy, in the absence of retrograde degeneration of the retinal nerve fibre layer and to ascertain if such patients may have any distinguishing clinical characteristics. We identified 50 patients with multiple sclerosis with predominantly macular thinning (normal retinal nerve fibre-layer thickness with average macular thickness <5th percentile), a previously undescribed optical coherence tomography defined phenotype in multiple sclerosis, and compared them with 48 patients with multiple sclerosis with normal optical coherence tomography findings, 48 patients with multiple sclerosis with abnormal optical coherence tomography findings (typical for multiple sclerosis) and 86 healthy controls. Utilizing a novel retinal segmentation protocol, we found that those with predominant macular thinning had significant thinning of both the inner and outer nuclear layers, when compared with other patients with multiple sclerosis (P < 0.001 for both), with relative sparing of the ganglion cell layer. Inner and outer nuclear layer thicknesses in patients with non-macular thinning predominant multiple sclerosis were not different from healthy controls. Segmentation analyses thereby demonstrated extensive deeper disruption of retinal architecture in this subtype than may be expected due to retrograde degeneration from either typical clinical or sub-clinical optic neuropathy. Functional corroboration of retinal dysfunction was provided through multi-focal electroretinography in a subset of such patients. These findings support the possibility of primary retinal pathology in a subset of patients with multiple sclerosis. Multiple sclerosis-severity scores were also significantly increased in patients with the macular thinning predominant phenotype, compared with those without this phenotype (n = 96, P = 0.006). We have identified a unique subset of patients with multiple sclerosis in whom there appears to be disproportionate thinning of the inner and outer nuclear layers, which may be occurring as a primary process independent of optic nerve pathology. In vivo analyses of retinal layers in multiple sclerosis have not been previously performed, and structural demonstration of pathology in the deeper retinal layers, such as the outer nuclear layer, has not been previously described in multiple sclerosis. Patients with inner and outer nuclear layer pathology have more rapid disability progression and thus retinal neuronal pathology may be a harbinger of a more aggressive form of multiple sclerosis. [ABSTRACT FROM AUTHOR]

Purpose: To report an atypical case of chorioretinopathy in a patient with bilateral renal transplantations. Methods: A 55-year-old female was referred for management of birdshot chorioretinopathy. Ophthalmologic examination revealed bilateral yellowish, chorioretinal lesions with adjacent hemorrhages. Results: Angiography demonstrated lesions with hyperfluorescence, leakage, and diffuse macular edema. OCT showed intraretinal edema. Laboratory evaluation revealed IgG antibodies for Bartonella hensalae. Treatment with oral ciprofloxacin led to regression of lesions, resolution of macular edema, and improvement in visual acuity. Conclusion: Multifocal chorioretinal lesions associated with B. hensalae can be atypical ophthalmic manifestations of cat-scratch disease (CSD), which may occur in immunosuppressed patients. Recognition of underlying disease and appropriate therapy can lead to improved outcomes. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study is to evaluate the differences in the fundus autofluorescence (FAF) signal between the blue light autofluorescence (BAF) from Spectralis® (Heidelberg, CA) and green light autofluorescence (GAF) 200TxTM (OPTOS, UK, in normal subjects and in patients with retinochoroidopathies (RC).Methods: In this prospective study, FAF was performed using BL (λ = 488 nm) and GL (λ = 532 nm) on normal subjects and patients with RC. The corresponding pairs of BAF and GAF images from both groups were analyzed using Photoshop. The strength of the FAF signal was measured on a gray scale, where optic disc was a standard to indicate absence of AF. In addition, gray values obtained from three identical points (foveal center, and points of hypo and hyper autofluorescence) in the corresponding BAF and GAF images of normal and RC subjects were divided by the optic disc value to calculate autofluorescence signal ratio (R). The R values at fovea (R1), hypoautofluorescent point (R2), and hyperautofluorescent point (R3) were compared between BAF and GAF modalities, in normal and in RC subjects separately.Results: One hundred six pairs (106 eyes) of FAF images analyzed (37 pairs: normal and 69 pairs: RC subjects). In normal subjects, the mean R1, R2, and R3 values for BAF were (1.5 ± 0.88, 1.23 ± 0.58, and 4.73 ± 2.85, respectively) and for GAF were (0.78 ± 0.20, 0.78 ± 0.20, and 1.62 ± 0.39, respectively). Similarly, in subjects with RC, the mean R1, R2, and R3 values for BAF were (1.68 ± 1.02, 1.66 ± 1.15, and 7.75 ± 6.82, respectively) and for GAF were (0.95 ± 0.59, 0.79 ± 0.45, and 2.50 ± 1.65, respectively). The mean difference in the R1, R2, and R3 ratios between BAF and GAF in normal and in RC subjects was statistically significant (p < 0.001). The strength of the correlation (r) between ratios for BAF and GAF was weak or not statistically significant in both normal and RC subjects (p > 0.05).Conclusion: The distribution and intensity of the AF signal differ in BAF and GAF and cannot be used interchangeably. In BAF, optic disc signal is always weaker than in other areas, which was not true for GAF where optic disc signal was stronger than fovea and hypoautofluorescent point in both groups. [ABSTRACT FROM AUTHOR]

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CDVA (≥20/400), visual field's MD value (≤−15), OCT's EZ integrity, parafoveal OCTA features, and straylight value (≥1.66) are possible prognostic factors in predicting VA after cataract surgery in RP cases. Retinitis pigmentosa (RP) is an inherited bilateral retinal degenerative disease with an incidence of 1 in 4000 people. RP affects more than 1 million individuals worldwide. Although night blindness and restricted visual field are the most typical symptoms of these individuals, generalized vision loss due to cataracts can be expected in the latter stages of the disease. It has been demonstrated that posterior subcapsular cataract is the most prevalent cataract in younger individuals with RP, as opposed to age-related cataracts. Although most ophthalmologists may have a negative view of cataract surgery in patients with RP, it appears that it can play an important role in the visual restoration of patients with RP. However, there are concerns about performing cataract surgery for patients with RP. Herein, a systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses on databases of MEDLINE and Scopus. [ABSTRACT FROM AUTHOR]

The article deals with several anti-vascular endothelial growth factor (VEGF) therapies for diabetic macular edema (DME). These include Pegabtanib, Ranibizumab, Bevacizumab, VEGF Trap, and Bevasiranib. An overview of the pathophysiology of DME is presented. It notes that the development of anti-VEGF therapies for the disease is a great breakthrough in ophthalmology and many of these treatments are in clinical trials and may be entering clinical practice in the near future.

Purpose To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME). Design Two similarly designed, randomized, phase 3 trials, VISTA DME and VIVID DME . Participants Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. Main Outcome Measures The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained ≥15 letters, and proportion of eyes with a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. Results Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters ( P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters ( P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% ( P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% ( P ≤ 0.0001) in VIVID. The proportion of eyes that lost ≥15 letters at week 100 was 3.2%, 0.7%, and 9.7% ( P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% ( P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a ≥2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control). Conclusions In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI. [ABSTRACT FROM AUTHOR]

Purpose: To investigate relationship between macular sensitivity and retinal thickness in diabetic macular edema (DME). Design: Prospective observational study. Methods: settings: University-based retina practice. patients: Twenty-two eyes of 11 patients with DME. procedure: Fundus microperimetry and retinal thickness tomography were performed simultaneously using an automatic fundus perimetry/tomography system. main outcome measures: Quantification of macular sensitivity, fixation pattern, and relationship between macular sensitivity and retinal thickness. Results: Fixation stability revealed that 21 eyes (95.4%) had stable fixation (>75% within central 2 degrees of point of fixation) and 1 eye (4.5%) had relatively unstable fixation (<75% of fixation points located within 2 degrees, >75% located within 4 degrees). Evaluation of fixation location revealed that 15 eyes (68.2%) had central (>50% of fixation points within 0.5 mm of fovea), 3 eyes (13.6%) pericentral (25% to 50% within 0.5 mm of fovea), and 4 eyes (18.2%) eccentric (<25% of fixation points within 0.5 mm of fovea) fixation location. Macular sensitivity increased by an average of 0.03 decibel (dB) (95% confidence interval [CI]: 0.00, 0.06) per 1-micron (μm) increase in retinal thickness for thickness values ≤280 μm measured with the OPKO/OTI spectral-domain OCT. The macular sensitivity decreased by an average 0.05 dB (95% CI: −0.08, −0.02) per 1-μm increase in thickness for thickness values >280 μm. Conclusions: In this pilot study, the majority of eyes with DME had stable, central fixation. Macular sensitivity varied depending on the thickness of the retina. Additional studies are needed to determine the role of microperimetry in eyes with DME. [ABSTRACT FROM AUTHOR]