Macugen (pegaptanib sodium), a novel ocular therapeutic that targets vascular endothelial growth factor (VEGF).
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Aptamers, Nucleotide↗
Biomedical subjects
Mauro Goldbaum
Publications and source records attributed to Mauro Goldbaum.
Changes in retinal neovascularization after pegaptanib (Macugen) therapy in diabetic individuals.
OBJECTIVE: To study effects of intravitreal pegaptanib (Macugen) on retinal neovascularization. DESIGN: Retrospective analysis of a randomized clinical trial. PARTICIPANTS, INTERVENTION, AND MAIN OUTCOME MEASURES: Individuals with retinal neovascularization identified from a multicenter, randomized, controlled trial evaluating pegaptanib for treatment of diabetic macular edema, with a best-corrected visual acuity letter score between 68 and 25 (approximate Snellen equivalent between 20/50 and 20/320) and receiving a sham injection or intravitreal pegaptanib (0.3 mg, 1 mg, 3 mg) administered at study entry, week 6, and week 12, with additional injections and/or focal photocoagulation as needed during the ensuing 18 weeks, up to a maximum of 6 pegaptanib/sham therapies, were evaluated. Scatter panretinal photocoagulation before study enrollment was permitted, but not within 6 months of randomization and study entry. Changes in retinal neovascularization were assessed on fundus photographs and fluorescein angiograms graded at a reading center in a masked fashion. RESULTS: Of 172 participants, 19 had retinal neovascularization in the study eye at baseline. Excluding 1 who had scatter photocoagulation 13 days before randomization and 2 with no follow-up photographs, 1 of the remaining 16 subjects had panretinal photocoagulation during study follow-up. Of these 16 subjects, 8 of 13 (62%) in a pegaptanib treatment group (including the one receiving panretinal photocoagulation), 0 of 3 in the sham group, and 0 of 4 fellow (nonstudy) eyes showed either regression of neovascularization on fundus photographs or regression or absence of fluorescein leakage from neovascularization (or both) at 36 weeks. In 3 of 8 with regression, neovascularization progressed at week 52 after cessation of pegaptanib at week 30. CONCLUSIONS: Most subjects with retinal neovascularization at baseline assigned to pegaptanib showed regression of neovascularization by week 36. These findings suggest a direct effect of pegaptanib upon retinal neovascularization in patients with diabetes mellitus.
Adult↗
A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema.
OBJECTIVE: To evaluate the safety and efficacy of pegaptanib sodium injection (pegaptanib) in the treatment of diabetic macular edema (DME). DESIGN: Randomized, double-masked, multicenter, dose-ranging, controlled trial. PARTICIPANTS: Individuals with a best-corrected visual acuity (VA) between 20/50 and 20/320 in the study eye and DME involving the center of the macula for whom the investigator judged photocoagulation could be safely withheld for 16 weeks. INTERVENTION: Intravitreous pegaptanib (0.3 mg, 1 mg, 3 mg) or sham injections at study entry, week 6, and week 12 with additional injections and/or focal photocoagulation as needed for another 18 weeks. Final assessments were conducted at week 36. MAIN OUTCOME MEASURES: Best-corrected VA, central retinal thickness at the center point of the central subfield as assessed by optical coherence tomography measurement, and additional therapy with photocoagulation between weeks 12 and 36. RESULTS: One hundred seventy-two patients appeared balanced for baseline demographic and ocular characteristics. Median VA was better at week 36 with 0.3 mg (20/50), as compared with sham (20/63) (P = 0.04). A larger proportion of those receiving 0.3 mg gained VAs of > or =10 letters (approximately 2 lines) (34% vs. 10%, P = 0.003) and > or =15 letters (18% vs. 7%, P = 0.12). Mean central retinal thickness decreased by 68 microm with 0.3 mg, versus an increase of 4 microm with sham (P = 0.02). Larger proportions of those receiving 0.3 mg had an absolute decrease of both > or =100 microm (42% vs. 16%, P = 0.02) and > or =75 microm (49% vs. 19%, P = 0.008). Photocoagulation was deemed necessary in fewer subjects in each pegaptanib arm (0.3 mg vs. sham, 25% vs. 48%; P = 0.04). All pegaptanib doses were well tolerated. Endophthalmitis occurred in 1 of 652 injections (0.15%/injection; i.e., 1/130 [0.8%] pegaptanib subjects) and was not associated with severe visual loss. CONCLUSIONS: In this phase II trial, subjects assigned to pegaptanib had better VA outcomes, were more likely to show reduction in central retinal thickness, and were deemed less likely to need additional therapy with photocoagulation at follow-up.
Adult↗
Peripapillary detachment in pathologic myopia.
OBJECTIVE: To describe peripapillary detachment in pathologic myopia (PDPM), a newly recognized fundus lesion. DESIGN: Retrospective medical record review. METHODS: We evaluated a series of myopic eyes that had a yellow-orange elevation of the retina and retinal pigment epithelium at the inferior border of the myopic conus. RESULTS: Twenty eyes of 15 patients were identified during a 17-year period to have characteristic findings of PDPM. The mean age of the patients was 58 years. They were followed up for an average of 6 years. The mean spherical equivalent correction was -11.00 diopters (D) (range, -6.00 to -16.00 D). The mean axial length was 27.4 mm (range, 25.3-28.9 mm). In each case, ophthalmic coherence tomographic examination showed a localized detachment of the retinal pigment epithelium and retina corresponding to the PDPM lesion. During the follow-up period, the lesion remained stable in all cases except for 1. No apparent negative effect on visual function was noted. CONCLUSIONS: Peripapillary detachment in pathologic myopia is an asymptomatic, yellow-orange peripapillary detachment of the retinal pigment epithelium and retina in pathologic myopia. Recognition of this lesion is important to distinguish it from other fundus pathologic conditions, such as tumors or choroidal neovascularization, which require further investigation and treatment.
Adult↗
Serous detachment of the retina.
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Body Fluids↗
Correlation of vitreous attachment and foveal deformation in early macular hole states.
PURPOSE: To report the foveal anatomy in patients with perifoveal posterior vitreous detachments (PPVD) using optical coherence tomography. DESIGN: Retrospective observational case series. METHODS: A retrospective study of fellow eyes of patients of patients with macular holes and those with early macular hole states were examined with optical coherence tomography, biomicroscopy, and contact b-scan ultrasonography. Twenty-three eyes of 23 patients were discovered to have PPVD, which was defined as persistent attachment of the vitreous to the central macula with a limited detachment of the posterior vitreous in the perifoveal region. RESULTS: The mean diameter of persistent vitreous attachment in eyes with no foveal deformation was 1829 microm, flattening of the foveal depression 840 microm, and with foveal cavitation 281 microm (P < .001, Spearman rank correlation). The difference in the mean diameters was significant (P = .001, Kruskal-Wallis test, all pairwise comparisons showing significant difference using the Mann-Whitney test). CONCLUSIONS: This study found that the diameter of the vitreous attachment in eyes with PPVD correlated with induced changes in foveal anatomy. The diameters of vitreous attachment were consistent with known regions of robust attachment of the vitreous determined histologically. Although the actual force loading on the central macula cannot be determined in patients with perifoveal posterior vitreous detachments, the stress, which is force / unit area may well increase with smaller areas of attachment leading to mechanical failure of the macula.
Fovea Centralis↗
Variability of three-dimensional ultrasonography for assessment of intraocular tumours.
BACKGROUND: Variability is introduced in three-dimensional (3-D) ultrasound assessments of intraocular tumours when multiple observers examine the same tumour or when multiple scans and measurements of the same tumour are carried out. We evaluated the magnitude and sources of variation associated with 3-D ultrasound measurements of choroidal tumour volume. METHODS: Three examiners performed 3-D ultrasonography of five choroidal tumours. Each examiner performed three scans of each tumour and then measured each scan three times to determine the volume. We determined the variation attributable to differences between examiners, scans and measurements by evaluating the contribution of each to the overall variation in tumour volume. A similar process was performed for tumour height for comparison purposes. RESULTS: The reliability of tumour volume measurements was found to be very high. The amount of overall variation, as defined by the coefficient of variation, was similar for tumour volume and tumour height and ranged from 4% to 17%. A total of 97% of the variation in tumour volume measurements and 84% of the variation in tumour height measurements was due to differences between tumours. Differences between examiners accounted for the most of the remaining variation (2% for volume and 7% for height). INTERPRETATION: Three-dimensional ultrasonography of intraocular tumours was highly reliable. Differences between examiners were the main source of variation.
Choroid Neoplasms↗