To assess the efficacy and safety of intravitreal inserts releasing 0.2 μg/day (low dose) or 0.5 μg/day (high dose) fluocinolone acetonide (FA) in patients with diabetic macular edema (DME).
Two ...parallel, prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trials.
Subjects with persistent DME despite at least 1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393).
Subjects received study drug or sham injection at baseline and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year.
The primary outcome was the percentage of patients with improvement from baseline best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Trial (ETDRS) letter score of 15 or more at month 24. Secondary outcomes included other parameters of visual function and foveal thickness (FTH).
The percentage of patients with improvement from baseline ETDRS letter score of 15 or more at month 24 was 28.7 and 28.6 in the low- and high-dose insert groups, respectively, compared with 16.2 in the sham group (P = 0.002 for each). Benefit occurred for both doses compared with sham at 3 weeks and all subsequent time points. The mean improvement in BCVA letter score between baseline and month 24 was 4.4 and 5.4 in the low- and high-dose groups, respectively, compared with 1.7 in the sham group (P = 0.02 and P = 0.016). At all time points compared with sham, there was significantly more improvement in FTH. Subjects requiring cataract surgery were more frequent in the insert groups, and their visual benefit was similar to that of subjects who were pseudophakic at baseline. Glaucoma requiring incisional surgery occurred in 3.7%, 7.6%, and 0.5% of the low-dose, high-dose, and sham groups, respectively.
Both low- and high-dose FA inserts significantly improved BCVA in patients with DME over 2 years, and the risk-to-benefit ratio was superior for the low-dose insert. This is the first pharmacologic treatment that can be administered by an outpatient injection to provide substantial benefit in patients with DME for at least 2 years.
Purpose: To highlight the high positive predictive value of the retinal pigmentary epithelium (RPE) irregularity and the shallow irregular retinal pigmented epithelium elevation (SIRE) sign in ...identifying nonexudative neovascular membranes and underscore the usefulness of these signs in clinical practice. Methods: Retrospective case series analysis conducted in the medical retina clinic in one center. Results: Seven cases of patients with nonexudative neovascular membranes confirmed with optical coherence tomography angiography (OCTA) imaging where RPE irregularity and/or SIRE sign had been described on standard structural optical coherence tomography (OCT). Conclusion: In this case series, we present a variety of phenotypes, some with apparently benign alterations, in which NE-MNV has been identified. Our findings suggest that OCTA screening for neovascular membranes is a useful tool for any patient presenting with irregular RPE and SIRE signal in their structural OCT image.
Background and Objective: Optical coherence tomography (OCT) plays a crucial role in guiding the treatment and establishing the prognosis of diabetic macular edema (DME). We aimed to determine which ...OCT biomarkers respond better to intravitreal triamcinolone acetonide (IVTA) switch after antivascular endothelial growth factor (anti-VEGF) treatment poor response. Materials and Methods: Fifty-eight eyes with DME, submitted to IVTA switch, were included in this retrospective study. OCT biomarkers and best-corrected visual acuity (VA) were assessed, before and after treatment with a mean follow-up of 2.9 months. Results: IVTA switch resulted in improved VA, central foveal thickness (CFT), and macular volume. Intraretinal cysts decreased or disappeared completely (P = 0.007) in 84.2% of the eyes, as well as the hyperreflective foci (P = 0.004) and the subretinal fluid (P = 0.02). Conclusion: We show that IVTA switch is an effective rescue therapy in anti-VEGF therapy refractory DME. OCT plays an important role in selecting the most appropriate treatment, namely between anti-VEGF and steroids.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Reactive oxygen species (ROS) overproduction and ROS-signaling pathways activation attack the eyes. We evaluated the oxidative stress (OS) and the effects of a daily, core nutritional supplement ...regimen containing antioxidants and omega 3 fatty acids (A/ω3) in type 2 diabetics (T2DM). A case-control study was carried out in 480 participants 287 T2DM patients with (+)/without (−) diabetic retinopathy (DR) and 193 healthy controls (CG), randomly assigned to a daily pill of A/ω3. Periodic evaluation through 38 months allowed to outline patient characteristics, DR features, and classic/OS blood parameters. Statistics were performed by the SPSS 24.0 program. Diabetics displayed significantly higher circulating pro-oxidants (p = 0.001) and lower antioxidants (p = 0.0001) than the controls. Significantly higher plasma malondialdehyde/thiobarbituric acid reactive substances (MDA/TBARS; p = 0.006) and lower plasma total antioxidant capacity (TAC; p = 0.042) and vitamin C (0.020) was found in T2DM + DR versus T2DM-DR. The differential expression profile of solute carrier family 23 member 2 (SLC23A2) gene was seen in diabetics versus the CG (p = 0.001), and in T2DM + DR versus T2DM − DR (p < 0.05). The A/ω3 regime significantly reduced the pro-oxidants (p < 0.05) and augmented the antioxidants (p < 0.05). This follow-up study supports that a regular A/ω3 supplementation reduces the oxidative load and may serve as a dietary prophylaxis/adjunctive intervention for patients at risk of diabetic blindness.
Introduction: Idiopatic Macular Telangiectasia (IMT) are a rare group of various entities presenting with incompetence, ectasia and/or irregular dilations of the juxtafoveolar capillaries of one or ...both eyes. Case Report: A 62 year old female with Glaucoma was sent to the Retina Department with a suspected diagnosis of retinal vein occlusion on the left eye (LE). Her best corrected visual acuity (BCVA) was 20/20 in the right eye (RE) and 20/25 in the LE. Slit lamp examination was normal; fundoscopy showed a cup-to-disc relation of 0.6 in the RE with normal macula and a cup-to-disc relation of 0.7 in the LE with multiple perifoveal microaneurysms, inferior temporal hard exudates and edema comproved with macular optical coherence tomography; fluorescein angiography revealed an area of hyperfluorescence with juxtafoveolar telangiectatic vessels located inferiorly and temporally to the fovea, with progressive filling and late active leakage in the LE. The diagnosis of IMT type 1 was made and she was treated with a loading dose of intravitreal injections of ranibizumab followed by a fourth injection because of persistent macular edema. One month after, her BCVA was 20/20 in the LE with improvement of macular edema and macular árgon laser photocoagulation was performed. Three months after the laser treatment her LE BCVA was 20/20 with fundoscopy showing small macular hemorrhages and microaneurysms. Conclusion: Macular edema and exudation are the main cause of visual loss in these patients. This case suggests that ranibizumab and laser photocoagulation can be effective in the treatment of type 1 IMT.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Purpose
Retinitis pigmentosa (RP) comprises a genetically and clinically heterogeneous group of inherited retinal degenerations, where 20–30% of patients exhibit extra-ocular manifestations ...(syndromic RP). Understanding the genetic profile of RP has important implications for disease prognosis and genetic counseling. This study aimed to characterize the genetic profile of syndromic RP in Portugal.
Methods
Multicenter, retrospective cohort study. Six Portuguese healthcare providers identified patients with a clinical diagnosis of syndromic RP and available genetic testing results. All patients had been previously subjected to a detailed ophthalmologic examination and clinically oriented genetic testing. Genetic variants were classified according to the American College of Medical Genetics and Genomics; only likely pathogenic or pathogenic variants were considered relevant for disease etiology.
Results
One hundred and twenty-two patients (53.3% males) from 100 families were included. Usher syndrome was the most frequent diagnosis (62.0%), followed by Bardet-Biedl (19.0%) and Senior-Løken syndromes (7.0%). Deleterious variants were identified in 86/100 families for a diagnostic yield of 86.0% (87.1% for Usher and 94.7% for Bardet-Biedl). A total of 81 genetic variants were identified in 25 different genes, 22 of which are novel.
USH2A
and
MYO7A
were responsible for most type II and type I Usher syndrome cases, respectively.
BBS1
variants were the cause of Bardet-Biedl syndrome in 52.6% of families. Best-corrected visual acuity (BCVA) records were available at baseline and last visit for 99 patients (198 eyes), with a median follow-up of 62.0 months. The mean BCVA was 56.5 ETDRS letters at baseline (Snellen equivalent ~ 20/80), declining to 44.9 ETDRS letters (Snellen equivalent ~ 20/125) at the last available follow-up (
p
< 0.001).
Conclusion
This is the first multicenter study depicting the genetic profile of syndromic RP in Portugal, thus contributing toward a better understanding of this heterogeneous disease group. Usher and Bardet-Biedl syndromes were found to be the most common types of syndromic RP in this large Portuguese cohort. A high diagnostic yield was obtained, highlighting current genetic testing capabilities in providing a molecular diagnosis to most affected individuals. This has major implications in determining disease-related prognosis and providing targeted genetic counseling for syndromic RP patients in Portugal.
Purpose: Overproduction of reactive oxygen species (ROS) leads to eye damage and causes effects of ROS signalling pathways. In this work, we evaluated oxidative stress (OS) biomarkers and the effects ...of a daily supplementation regimen containing antioxidants and essential fatty acids (A/ω3) in type 2 diabetic eyes (T2DM).
Methods: This is a case–control study involving 480 participants, divided into 2 groups: (1) T2DM patients (n = 287) with (+)/without (−) non‐proliferative diabetic retinopathy (NPDR) and (2) controls (CG; n = 194)). Participants were randomly assigned to a daily pill of A/ω3. Patients were followed‐up for 38 months, allowing to outline patient characteristics, NPDR status, and classical and emerging blood parameters, including OS markers (candidate products and genes). Statistical analysis was performed using the SPSS 24.0 program.
Results: Significantly higher levels of circulating pro‐oxidants (p = 0.001) and lower levels of antioxidants (p = 0.0001) were detected in patients with T2DM versus CG. Plasma malondialdehyde/thiobarbituric acid reactive species were significantly higher (MDA/TBARS; p = 0.006) and lower antioxidant load, based on the total antioxidant capacity of plasma (TAC; p = 0.042) and vitamins B12 (p = 0.05) and C (p = 020) levels were found inT2DM + NPDR versus T2DM‐NPDR. Overexpression of the matrix metalloproteinase‐9 (MMP‐9) gene was found in T2DM + NPDR versus T2DM‐NPDR and in GC (p = 0.021). It is important to note that the therapeutic regime with A/ω3 supplementation in all groups proved to be beneficial, particularly in the group of patients with diabetic retinopathy (DR).
Conclusions: This study stresses the need for new strategies to increase the antioxidant load, as in the case of the A/ω3 supplementation regime, which can serve as a dietary prophylaxis and adjunctive intervention for better ophthalmic care in patients at risk of associated blindness to DR.
A 43-year-old man presented with a decrease of vision in the left eye after blunt ocular trauma. Visual acuity was of 20/20 in the right eye and 20/100 in the left eye. Fundus examination revealed a ...choroid rupture and submacular hemorrhage. Three months after the trauma, it was evident the development of choroidal neovascularization (CNV). A serie of intravitreal injections of ranibizumab were initiated. The optical coherence tomography angiography (OCTA) demonstrated to be better than fluorescein angiography (FA) to show evidence of CNV, and was essential to follow up the progression and guide therapeutic decisions. Decision for treatment based on OCTA findings lead to an excellent visual acuity outcome with visual acuity of 20/25 seven months after the trauma.
To examine the relationship between microaneurysm turnover (formation rate), using a new semi-automatic method (MA-Tracker) based on color fundus photographs, and diabetic retinopathy (DR) ...progression to clinically significant macular edema (CSME).
In total, 113 patients/eyes with nonproliferative DR (NPDR) were followed up every 6 months for 2 years as controls of the DR clinical trials, and by conventional general and ophthalmological care for the next 8 years (over a total of 10 years' follow-up). Microaneurysm turnover for the 2 first years was computed using the MA-Tracker.
The 17 patients that developed CSME over the 10 years of follow-up presented a microaneurysm formation rate of 9.2 +/- 18.2 microaneurysms/year (mean +/- SD) during the first 2 years, which was statistically higher than the eyes that did not develop CSME (0.5 +/- 1.2 microaneurysms/year, p < 0.001). These 17 patients also presented higher HbA(1C) levels at baseline (8.5 +/- 1.2%) compared to the patients who did not develop CSME (7.3 +/- 1.2%, p = 0.001).
A high microaneurysm formation rate on color fundus photographs appears to be a good biomarker for DR progression to CSME in type 2 diabetic patients with NPDR.
A 43-year-old man presented with decreased vision in the left eye after a blunt ocular trauma. Visual acuity was of 20/20 in the right eye and 20/100 in the left eye. Fundus examination revealed a ...choroidal rupture and a submacular hemorrhage. Three months after trauma it was evident the development of choroidal neovascularization (CNV) and intravitreal ranibizumab injections were initiated. The optical coherence tomography angiography (OCTA) was better than fluorescein angiography to show evidence of CNV and was essential to follow up the progression and guide the therapeutic decisions. The treatment decision based on the OCTA findings lead to a good visual acuity outcome with a visual acuity of 20/25 seven months after the trauma.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
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