Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Patients With Neovascular Age-Related Macular Degeneration: Studies in Japan and the United States

BACKGROUND AND OBJECTIVE: To evaluate comparability of abicipar pegol (abicipar) effects in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in Japan and the United States. PATIENTS AND METHODS: Phase 2, multicenter, randomized, double-masked, 20-week studies (BAMBOO, Japan; CYPRESS, United States). Patients (n = 25 each study) received three monthly intravitreal injections of abicipar 1 mg or 2 mg or five monthly intravitreal injections of ranibizumab 0.5 mg. RESULTS: Mean best-corrected visual acuity change from baseline at week 16 (primary endpoint) for abicipar 1 mg, abicipar 2 mg, and ranibizumab was +7.8 letters, +8.9 letters, and +17.4 letters (BAMBOO); +4.4 letters, +10.1 letters, and +15.2 letters (CYPRESS). Mean central retinal thickness change from baseline was −187.3 μm, −196.5 μm, and −230.4 μm (BAMBOO); −106.5 μm, −112.8 μm, and −124.4 μm (CYPRESS). Uveitis or vitritis was reported in three abicipar-treated patients. CONCLUSION: Abicipar demonstrated extended duration of effect and safety that were comparable between Japanese and non-Japanese patients with nAMD. Abicipar effectively treated Japanese patients with polypoidal choroidal vasculopathy

Trends in antibiotic resistance of corneal pathogens: Part I. An analysis of commonly used ocular antibiotics

Purpose: To analyse commonly used ocular antibiotics and determine their in-vitro efficacies against bacterial keratitis pathogens. Methods: A retrospective review of microbiology records at the LV Prasad Eye Institute in Hyderabad, India identified 1,633 bacterial keratitis isolates. Antibiotic susceptibility of corneal isolates was determined for various ocular antibiotics using the Kirby-Bauer disc-diffusion method. Results: Cefazolin had coverage against 1,296 (83.0%) of 1,562 isolates tested; chloramphenicol against 1,136 (71.7%) of 1,585 isolates; ciprofloxacin against 1,080 (69.3%) of 1,558 isolates; gentamicin against 1,106 (70.6%) of 1,567 isolates; norfloxacin against 1,057 (67.7%) of 1,561 isolates; vancomycin against 463 (84.3%) of 549 isolates; and framycetin against 105 (36.2%) of 290 isolates. Also included is a breakdown by species, and sensitivity profiles for resistant isolates.Conclusion: This study provides information on the efficacies of ocular antibiotics commonly used against bacterial keratitis pathogens. It also examines the antibiotic susceptibility profiles for corneal pathogens that are resistant to an ocular antibiotic but sensitive to other selected antibiotics. It is hoped that this information will aid in the decision-making of empiric initial treatment of bacterial keratitis

Trends in antibiotic resistance of corneal pathogens: Part I. An analysis of commonly used ocular antibiotics

Purpose: To analyse commonly used ocular antibiotics and determine their in-vitro efficacies against bacterial keratitis pathogens. Methods: A retrospective review of microbiology records at the LV Prasad Eye Institute in Hyderabad, India identified 1,633 bacterial keratitis isolates. Antibiotic susceptibility of corneal isolates was determined for various ocular antibiotics using the Kirby-Bauer disc-diffusion method. Results: Cefazolin had coverage against 1,296 (83.0%) of 1,562 isolates tested; chloramphenicol against 1,136 (71.7%) of 1,585 isolates; ciprofloxacin against 1,080 (69.3%) of 1,558 isolates; gentamicin against 1,106 (70.6%) of 1,567 isolates; norfloxacin against 1,057 (67.7%) of 1,561 isolates; vancomycin against 463 (84.3%) of 549 isolates; and framycetin against 105 (36.2%) of 290 isolates. Also included is a breakdown by species, and sensitivity profiles for resistant isolates.Conclusion: This study provides information on the efficacies of ocular antibiotics commonly used against bacterial keratitis pathogens. It also examines the antibiotic susceptibility profiles for corneal pathogens that are resistant to an ocular antibiotic but sensitive to other selected antibiotics. It is hoped that this information will aid in the decision-making of empiric initial treatment of bacterial keratitis

Trends in antibiotic resistance of corneal pathogens: Part II. An analysis of leading bacterial keratitis isolates

Purpose: To analyse leading bacterial keratitis pathogens for in-vitro susceptiblity to commonly used ocular antibiotics and to determine trends in antibiotic susceptibility for these pathogens. Methods: A retrospective review of microbiology records from 1991-1997 at the LV Prasad Eye Institute, Hyderabad, India identified the five leading bacterial keratitis pathogens.. Antibiotic susceptibility of corneal isolates was determined for various ocular antibiotics using the Kirby-Bauer disc-diffusion method. Results: Linear regression analyses were performed. Statistically significant trends included a 3.56% increase per year in the percentage of Staphylococcus epidermidis isolates susceptible to chloramphenicol (p = 0.032) [-6.61 - -0.51, 95% CI]; a 9.93% decrease per year in the percentage of Corynebacterium species isolates susceptible to ciprofloxacin (p = 0.050) [0 -19.86, 95% CI]; a 0.69% increase per year in the percentage of Staphylococcus aureus isolates susceptible to gentamicin (p = 0.012) [-11.35 - -2.49, 95% CI]; and a 5.53% increase per year in the percentage of Staphylococcus aureus isolates susceptible to norfloxacin (p = 0.040) [-10.66 - -0.40, 95% CI]. A trend of borderline significance included a 3.77% decrease per year in the percentage of Pseudomonas aeruginosa isolates susceptible to ciprofloxacin (p=0.064) [-0.34 - 7.89]. Conclusion: This study provides information on the trends in antibiotic susceptibility for the leading bacterial keratitis pathogens. It is hoped that this study will provide a rational approach for initial therapy, taking into account changing trends in antibiotic susceptibility

Evaluation of corneal scraping smear examination methods in the diagnosis of bacterial and fungal keratitis: a survey of eight years of laboratory experience

Purpose: To determine the sensitivity, specificity, and predictive values of Gram and potassium hydroxide with calcofluor white (KOH+CFW) stains in the diagnosis of early and advanced microbial keratitis, a retrospective analysis of comparative data from a prospectively collected database was done. Methods: Patients with nonviral microbial keratitis seen at L.V. Prasad Eye Institute between February 1991 and December 1998 were included in the study. The type of bacteria seen on Gram stain was determined from 251 corneal scrapings from patients with early keratitis and 841 corneal scrapings from patients with advanced keratitis. The presence of fungi in corneal scrapings was determined by KOH+CFW stain of 114 and 363 scrapings from patients with early and advanced keratitis, respectively. The smear findings were compared with culture results to analyze specificity, sensitivity, and predictive values of the staining techniques. Results: The sensitivity of Gram stain in the detection of bacteria was 36.0% in early and 40.9% in advanced keratitis cases; however, the specificity was higher in both groups (84.9% and 87.1%, respectively). Comparatively, the sensitivity and specificity of fungal detection were higher using KOH+CFW in early (61.1% and 99.0%, respectively) as well as advanced keratitis (87.7% and 83.7%, respectively). Predictive values were high for KOH+CFW in fungus detection, while they were poor for Gram stain in bacteria detection. In advanced keratitis cases, the false positives were higher in fungal detection (16.3%) than in bacterial detection (10.3%), while the false negatives were significantly higher in bacterial detection compared with fungal detection (59.1% versus 12.3%, p< 0.0001). In early keratitis, on the other hand, both false positives and false negatives for bacterial detection were significantly higher than fungal detection. Conclusions: Decisions can reliably be based on KOH+CFW stain of corneal scrapings for initiation of antifungal therapy in mycotic keratitis. The results of Gram stain, on the other hand, have limited value in therapeutic decisions for bacterial keratitis. Therefore, the search for a better modality for early and efficient diagnosis of bacterial keratitis needs to continue

Relationship between Clinical Presentation and Visual Outcome in Postoperative and Posttraumatic Endophthalmitis in South Central India

PURPOSE: To determine risk factors for poor visual outcome in postoperative and posttraumatic endophthalmitis in a large referral center in south central India. METHODS: In this prospective observational series the authors examined 388 patients of postoperative (n= 206) and posttraumatic (n= 182) endophthalmitis at the L V Prasad Eye Institute in Hyderabad, India between 1991 and 1997.The analysis was confined to 236 patients-128 (62.1&#x0025;) postoperative and 108 (59.3&#x0025;) posttraumatic patients who were followed for a minimum period of 3 months. A detailed protocol was followed. Chi-square and logistic regression analysis were used to determine risk factors for visual outcome worse than 6/18 and worse than 6/120. RESULTS: Postoperative endophthalmitis: In univariate analysis the features associated with poor visual acuity (grouped as &lt; 6/18 and &lt; 6/120) included intracapsular cataract surgery, poor presenting visual acuity, presence of vitreous cells, inability to visualise the optic disc on indirect ophthalmoscopy, presence of vitreous membranes on ultrasonography, and a culture-positive vitreous biopsy. In the multivariate analysis, visual acuity of &lt; light perception (LP) at presentation was associated with a 3-month postoperative visual acuity of &lt; 6/18, with an odds ratio of 5.85 [ 1.25 - 27.42, 95&#x0025; CI], and vitreous membranes seen on ultrasonography was associated with a final visual acuity of &lt; 6/120, with an odds ratio of 2.47 [1.05 - 5.83, 95&#x0025; CI]. Posttraumatic endophthalmitis: In univariate analysis the features associated with poor visual acuity (grouped as &lt; 6/18 and &lt; 6/120) included a retained intraocular foreign body (IOFB), trauma by needle (hypodermic or sewing), poor presenting visual acuity, inability to visualise the optic disc on indirect ophthalmoscopy, presence of vitreous membranes on ultrasonography, and a culture-positive vitreous biopsy. In multivariate analysis, IOFB was associated with a 3-month follow-up visual acuity of &lt; 6/18, with an odds ratio of 5.90 [1.85 - 18.78, 95&#x0025; CI], and trauma by a needle (hypodermic or sewing) and retained IOFB was associated with a final visual acuity of &lt; 6/120, with an odds ratio of 4.47 [1.22 - 16.38, 95&#x0025;CI] and 3.76 [1.36 - 10.37, 95&#x0025; CI] respectively. CONCLUSION: This is the largest, single-centre, prospective study on risk factors for poor visual outcome in postoperative and posttraumatic endophthalmitis. The independent risk factor for 3-month follow-up visual acuity of &lt; 6/18 was the presenting visual acuity of &#8804;LP in postoperative endophthalmitis and a retained IOFB in posttraumatic endophthalmitis. The independent risk factor for 3-month visual acuity of <6/120 was the presence of vitreous membranes on ultrasonography in postoperative endophthalmitis, and trauma by a needle (hypodermic/ sewing) and retained IOFB in posttrauamtic endophthalmitis

Microbial keratitis in children

Objective: Microbial keratitis is a major cause of corneal blindness worldwide. This problem is particularly relevant to children, because most of their visual life is ahead of them, and they are uniquely at risk for irreversible ocular deficits, such as those resulting from amblyopia. The objective of this study was to determine the etiologic agents and predisposing factors in childhood infectious keratitis and to examine the outcome of treatment in terms of structure and visual acuity. Design: The study design was a retrospective case series. Participants: The authors studied 113 eyes in 107 children 16 years of age and younger who were treated for (nonviral) microbial keratitis at the LV Prasad Eye Institute in Hyderabad, India, during the 4.5-year period between February 1, 1991, and June 30, 1995. Intervention: The patients who met the following criteria were included in the study: (1) corneal stromal infiltrate was present on slit-lamp examination; and (2) a corneal scraping was taken at the time of examination for suspected microbial keratitis. Main Outcome Measures: Etiologic micro-organisms, predisposing factors, treatment method, structural treatment outcome, and visual acuity treatment outcome of the infectious keratitis episode were measured. Results: The principal predisposing factors identified in this study were trauma (21.2%), ocular disease (17.7%), systemic disease (15.9%), and prior penetrating keratoplasty in the same eye (8.8%). Vitamin A deficiency was an important factor within the category of severe systemic disease, and contact lens wear was not involved in any of the cases. A total of 85 organisms were isolated in cultures of corneal scrapings from 64 (56.6%) of the 113 cases. Staphylococcus species (43.7%), Streptococcus pneumoniae (18.8%), and fungi (17.2%) were the most common isolates. Eighteen eyes (15.9%) required surgery, and 28 (36.4%) of the 77 patients on whom visual acuity was assessed at last follow-up achieved an unaided visual acuity of 20/60 or better at last follow-up. Conclusion: This work represents the largest recent study on childhood (nonviral) microbial keratitis, its management, and treatment outcomes. In this study, amblyopia is highlighted as a potentially significant sequela of childhood microbial keratitis. Identification of the appropriate predisposing factors, etiologic microbial organisms, and treatment outcome from this study may aid in early recognition and treatment of microbial keratitis in children