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Comparison of efficacy between anti-vascular endothelial growth factor (VEGF) and laser treatment in Type-1 and threshold retinopathy of prematurity (ROP).
Li, Z, Zhang, Y, Liao, Y, Zeng, R, Zeng, P, Lan, Y
BMC ophthalmology. 2018;(1):19
Abstract
BACKGROUND Retinopathy of Prematurity (ROP) is one of the most common causes of childhood blindness worldwide. Comparisons of anti-VEGF and laser treatments in ROP are relatively lacking, and the data are scattered and limited. The objective of this meta-analysis is to compare the efficacy of both treatments in type-1 and threshold ROP. METHODS A comprehensive literature search on ROP treatment was conducted using PubMed and Embase up to March 2017 in all languages. Major evaluation indexes were extracted from the included studies by two authors. The fixed-effects and random-effects models were used to measure the pooled estimates. The test of heterogeneity was performed using the Q statistic. RESULTS Ten studies were included in this meta-analysis. Retreatment incidence was significantly increased for anti-VEGF (OR 2.52; 95% CI 1.37 to 4.66; P = 0.003) compared to the laser treatment, while the incidences of eye complications (OR 0.29; 95% CI 0.10 to 0.82; P = 0.02) and myopia were significantly decreased with anti-VEGF compared to the laser treatment. However, there was no difference in the recurrence incidence (OR 1.86; 95% CI 0.37 to 9.40; P = 0.45) and time between treatment and retreatment (WMD 7.54 weeks; 95% CI 2.00 to 17.08; P = 0.12). CONCLUSION This meta-analysis indicates that laser treatment may be more efficacious than anti-VEGF treatment. However, the results of this meta-analysis also suggest that laser treatment may cause more eye complications and increase myopia. Large-scale prospective RCTs should be performed to assess the efficacy and safety of anti-VEGF versus laser treatment in the future.
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CLINICAL EVIDENCE OF THE MULTIFACTORIAL NATURE OF DIABETIC MACULAR EDEMA.
Chakravarthy, U, Yang, Y, Lotery, A, Ghanchi, F, Bailey, C, Holz, FG, Downey, L, Weber, M, Eter, N, Dugel, PU
Retina (Philadelphia, Pa.). 2018;(2):343-351
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PURPOSE To report functional and morphologic outcomes, based on diabetic macular edema (DME) chronicity and baseline best-corrected visual acuity (BCVA), from a subanalysis of the fluocinolone acetonide for macular edema (FAME) trials. METHODS Patients were categorized by DME duration (nonchronic [ncDME] or chronic [cDME] DME) and three nonexclusive baseline vision strata. Anatomic and visual acuity VA outcomes of these cohorts were compared with treatment assignment. RESULTS For all patients with ncDME and cDME who received sham control, 27.8% and 13.4%, respectively, gained ≥15 BCVA letters, whereas 22.3% and 34.0% of 0.2 μg/day fluocinolone acetonide (FAc)-treated patients, respectively, gained ≥15 BCVA letters. Among patients with ncDME who received sham control, as baseline vision decreased, the percentage gaining ≥15 BCVA letters increased; however, among those with cDME, the percentage gaining ≥15 BCVA letters did not change as baseline vision decreased. Conversely, among 0.2 μg/day FAc-treated patients, the percentage gaining ≥15 BCVA letters increased with decreasing baseline vision, regardless of DME chronicity. Anatomical outcomes were similar within treatment arms, regardless of the DME duration. CONCLUSION Patients with cDME and poor baseline vision who were exposed to low-dose FAc experienced BCVA improvements that were not observed in a similar group from the sham-control arm. These data support the multifactorial pathogenesis of cDME.
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A randomized clinical trial evaluating choroidal blood flow and morphology after conventional and pattern scan laser panretinal photocoagulation.
Mikoshiba, Y, Iwase, T, Ueno, Y, Yamamoto, K, Ra, E, Terasaki, H
Scientific reports. 2018;(1):14128
Abstract
We prospectively investigated the changes in choroidal blood flow and morphology after panretinal photocoagulation (PRP) in 39 eyes with severe nonproliferative diabetic retinopathy (S-NPDR). Seventeen eyes underwent PRP by conventional laser and 22 eyes underwent pattern scan laser (PASCAL). The choroidal blood flow was assessed by laser speckle flowgraphy, and the subfoveal choroidal thickness (SFCT) was measured with optical coherence tomography before and 1, 4, 8, and 12 weeks after the two types of PRP treatments. The choroidal mean blur rate (MBR) at the macular region was significantly reduced to 86.4% of the baseline level in the conventional laser group and 85.7% in the PASCAL group at Week 12 (P = 0.001, P < 0.001, respectively). The SFCT was significantly increased at 1 week following PRP but it was significantly reduced at Week 8 (P = 0.001, P < 0.001, respectively) in both groups. The differences in the ratio of the MBR and the SFCT was not significant between the conventional laser and PASCAL groups at any time after PRP. The results suggest that appropriate PRP treatments even by the PASCAL method will reduce the choroidal blood flow and the choroidal morphological components.
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Cost Evaluation of Early Vitrectomy versus Panretinal Photocoagulation and Intravitreal Ranibizumab for Proliferative Diabetic Retinopathy.
Lin, J, Chang, JS, Yannuzzi, NA, Smiddy, WE
Ophthalmology. 2018;(9):1393-1400
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PURPOSE To evaluate costs and cost-utility of early vitrectomy (pars plana vitrectomy [PPV]) compared with panretinal photocoagulation (PRP) and intravitreal ranibizumab (IVR) for proliferative diabetic retinopathy (PDR) without diabetic macular edema. DESIGN A decision analysis model of cost-utility. PARTICIPANTS There were no participants. METHODS A decision analysis was based on results from the Diabetic Retinopathy Clinical Research Network Protocol S comparing treatment of PRP with IVR (0.3 mg) in PDR without incident macular edema to model the total 2-year costs and outcomes for each treatment scenario. These values were compared with the 2-year hypothetical costs of early PPV for PDR. Centers for Medicare and Medicaid Services data were used to calculate associated modeled costs in a hospital/facility-based and nonfacility setting. Cost-utility was calculated on the basis of the preserved visual utility and estimated life years remaining. In addition, costs for lifetime treatment were modeled for all scenarios and used to calculate lifetime quality-adjusted life years (QALY) costs for each scenario. Sensitivity analyses were performed to evaluate the impact of the model's assumptions. MAIN OUTCOME MEASURES Cost of treatment, utility, and cost per QALY. RESULTS The modeled cost per QALY of treatment for PDR for 2 years of utility in the facility (nonfacility) setting was $163 988 ($102 559) in the PRP group, $436 992 ($326 424) in the IVR group, and $181 144 ($107 965) in the PPV group. Sensitivity analysis showed that both IVR and PPV groups would have equivalent costs per QALY over the first 2 years if 78% (facility) and 80% (nonfacility) of patients in the PPV group required additional treatment with IVR (at the dose of 10.1 injections as in Protocol S). Beyond 2 years, the cost per QALY in the facility (nonfacility) setting was calculated as $61 695 ($21 752) in the PRP group, $338 348 ($239 741) in the IVR group, and $63 942 ($22 261) in the PPV group. CONCLUSIONS Early PPV as a strategy for treatment of PDR without macular edema demonstrates cost-utility similar to management with PRP and more favorable cost-utility compared with IVR in the short term. This advantage over IVR continues when lifetime costs are factored.
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Patient Comfort with Yellow (577 nm) vs. Green (532 nm) Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy.
Adam, MK, Weinstock, BM, Kasi, SK, Ehmann, DS, Hsu, J, Garg, SJ, Ho, AC, Chiang, A
Ophthalmology. Retina. 2018;(2):91-95
Abstract
PURPOSE Pain associated with panretinal photocoagulation (PRP) can adversely affect the number and quality of retinal burns delivered and subsequently increase the number of treatment sessions required to achieve regression of proliferative diabetic retinopathy (PDR). We assessed comfort in patients undergoing treatment with yellow (577 nm) vs. green (532 nm) PRP for PDR. DESIGN Prospective, single-center, randomized crossover clinical trial. SUBJECTS Patients with PDR with high-risk characteristics. METHODS Subjects were equally randomized to first receive PRP with a laser indirect ophthalmoscope with either green (IQ 532; IRIDEX, Mountain View, CA) or yellow (IQ 577; IRIDEX) laser, followed by additional treatment with the opposite laser using standardized settings in the superior hemisphere of a single treatment eye per patient. Topical anesthetic was used in all study eyes before each treatment and power was titrated until moderate grey-white retinal burns were achieved. MAIN OUTCOME MEASURES The primary outcome measure was patient's perceived pain as measured with a standardized 10-point pain scale. Secondary outcome measures included laser power, treatment time, number of treatment shots with each laser, and physician ease-of-use score with each laser on a 10-point scale. RESULTS Forty patients (40 eyes) with a mean age of 54.0 years were enrolled. Mean pain scores were similar when comparing treatment with yellow and green laser (3.1 ± 2.3 vs. 2.8 ± 2.6; P = 0.40). No significant difference was seen in visual acuity (P = 0.44) or central macular thickness (P = 0.39) 1 month after PRP. Additionally, there were no significant differences when comparing minimum power required (243.2 ± 74.2 vs. 234.0 ± 59.6 mW; P = 0.55), treatment time (5.1 ± 3.6 vs. 5.6 ± 3.9 minutes; P = 0.384), and number of treatment shots (257.6 ± 12.6 vs. 258.0 ± 2.3; P = 0.68). Six of 7 co-investigators (85%) preferred using yellow laser over green and reported ease-of-use scores of 9.0 ± 1.2 and 7.6 ± 1.4, respectively (P = 0.07). No severe adverse events occurred. CONCLUSIONS Patient comfort during PRP for PDR utilizing laser indirect ophthalmoscopy is similar for green and yellow wavelengths.
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Ranibizumab Plus Panretinal Photocoagulation versus Panretinal Photocoagulation Alone for High-Risk Proliferative Diabetic Retinopathy (PROTEUS Study).
Figueira, J, Fletcher, E, Massin, P, Silva, R, Bandello, F, Midena, E, Varano, M, Sivaprasad, S, Eleftheriadis, H, Menon, G, et al
Ophthalmology. 2018;(5):691-700
Abstract
PURPOSE Comparison of the efficacy of ranibizumab (RBZ) 0.5 mg intravitreal injections plus panretinal photocoagulation (PRP) versus PRP alone in the regression of the neovascularization (NV) area in subjects with high-risk proliferative diabetic retinopathy (HR-PDR) over a 12-month period. DESIGN Prospective, randomized, multicenter, open-label, phase II/III study. PARTICIPANTS Eighty-seven participants (aged ≥18 years) with type 1/2 diabetes and HR-PDR (mean age, 55.2 years; 37% were female). METHODS Participants were randomized (1:1) to receive RBZ+PRP (n = 41) or PRP monotherapy (n = 46). The RBZ+PRP group received 3 monthly RBZ injections along with standard PRP. The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators' discretion. MAIN OUTCOME MEASURES The primary outcome was regression of NV total, on the disc (NVD) plus elsewhere (NVE), defined as any decrease in the area of NV from the baseline to month 12. Secondary outcomes included best-corrected visual acuity (BCVA) changes from baseline to month 12, time to complete NV regression, recurrence of NV, macular retinal thickness changes from baseline to month 12, need for treatment for diabetic macular edema, need for vitrectomy because of occurrence of vitreous hemorrhage, tractional retinal detachment or other complications of DR, and adverse events (AEs) related to treatments. RESULTS Seventy-seven participants (88.5%) completed the study. Overall baseline demographics were similar for both groups, except for age. At month 12, 92.7% of participants in the RBZ+PRP group presented NV total reduction versus 70.5% of the PRP monotherapy participants (P = 0.009). The number of participants with NVD and NVE reductions was higher with RBZ+PRP (93.3% and 91.4%, respectively) versus PRP (68.8% and 73.7%, respectively), significant only for NVE (P = 0.048). Complete NV total regression was observed in 43.9% in the RBZ+PRP group versus 25.0% in the PRP monotherapy group (P = 0.066). At month 12, the mean BCVA was 75.2 letters (20/32) in the RBZ+PRP group versus 69.2 letters (20/40) in the PRP monotherapy group (P = 0.104). In the RBZ+PRP group, the mean number of PRP treatments over month 12 was 3.5±1.3, whereas in the PRP monotherapy group, it was 4.6±1.5 (P = 0.001). No deaths or unexpected AEs were reported. CONCLUSIONS Treatment with RBZ+PRP was more effective than PRP monotherapy for NV regression in HR-PDR participants over 12 months.
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Follow-up to Age 4 Years of Treatment of Type 1 Retinopathy of Prematurity Intravitreal Bevacizumab Injection versus Laser: Fluorescein Angiographic Findings.
Lepore, D, Quinn, GE, Molle, F, Orazi, L, Baldascino, A, Ji, MH, Sammartino, M, Sbaraglia, F, Ricci, D, Mercuri, E
Ophthalmology. 2018;(2):218-226
Abstract
PURPOSE To compare structural outcome at age 4 years of eyes treated with intravitreal injection of bevacizumab with fellow eyes treated with conventional laser photoablation in type 1 retinopathy of prematurity (ROP). DESIGN Single, randomized, controlled trial. PARTICIPANTS All inborn babies with type 1 zone 1 ROP at the Neonatal Intensive Care Unit of the Catholic University, Rome, from September 1, 2009, to March 31, 2012. METHODS In 21 infants (42 eyes), 1 eye was randomized to receive an intravitreal injection of 0.5 mg bevacizumab; the fellow eye underwent conventional laser photoablation. Digital retinal imaging and fluorescein angiography (FA) were performed at an average of 4 years after treatment in follow-up after these studies performed at treatment and 9 months. MAIN OUTCOME MEASURES Fluorescein angiograms were examined by 2 experts to document retinal and choroidal findings. RESULTS Among the 20 bevacizumab-treated eyes available at 4 years of age, all showed abnormalities at the periphery (avascular area, vessel leakage, shunts, abnormal vessel branching, and tangles) or the posterior pole (hyperfluorescent lesions, absence of foveal avascular zone). These lesions were not observed in the majority of the lasered eyes. Among the 19 laser-treated eyes, leakage was noted in 1 eye, shunts and tangles were noted in 3 eyes, and macular abnormalities were noted in 3 eyes. CONCLUSIONS Fluorescein angiography has shown potentially serious and long-term ocular effects that are present more commonly after treatment with bevacizumab for acute-phase ROP than after laser.
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Baseline Factors Affecting Changes in Diabetic Retinopathy Severity Scale Score After Intravitreal Aflibercept or Laser for Diabetic Macular Edema: Post Hoc Analyses from VISTA and VIVID.
Dhoot, DS, Baker, K, Saroj, N, Vitti, R, Berliner, AJ, Metzig, C, Thompson, D, Singh, RP
Ophthalmology. 2018;(1):51-56
Abstract
PURPOSE To evaluate whether select baseline systemic and ocular factors influence ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score at week 100 in VISTA and VIVID. DESIGN Post hoc analysis of 2 similarly designed phase 3 trials, VISTA and VIVID. PARTICIPANTS Total of 456 patients with center-involved diabetic macular edema (DME). METHODS VISTA and VIVID randomized 872 DME patients to receive intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or macular laser photocoagulation. This post hoc analysis evaluated the influence of select baseline factors on ≥2-step DRSS score improvement by logistic regression in an integrated VISTA and VIVID dataset using observed cases (n = 456) with patients in each treatment group divided into tertiles based on each characteristic. MAIN OUTCOME MEASURES Proportion of patients with ≥2-step improvement in DRSS score from baseline at week 100 by age, duration of diabetes, hemoglobin A1c (HbA1c), body mass index (BMI), best-corrected visual acuity (BCVA), central subfield thickness (CST), and DRSS score. RESULTS At week 100, 10.1%, 34.3%, and 37.6% of patients in the laser, 2q4, and 2q8 groups experienced a ≥2-step DRSS score improvement, respectively. Age, duration of diabetes, HbA1c, BMI, BCVA, and CST had no impact on the ability to achieve ≥2-step improvement in DRSS score. Initial DRSS score was the only factor significantly associated with ≥2-step DRSS score improvement in all treatment groups at weeks 24, 52, 76, and 100. Relatively higher proportions of IAI-treated patients with worse BCVA or thicker CST experienced ≥2-step DRSS score improvement compared with those with better BCVA or thinner CST, respectively, but these associations were not statistically significant. CONCLUSION A strong association was present between baseline DRSS score and ≥2-step DRSS score improvement at week 100 for DME patients in VISTA and VIVID.
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The RELATION study: efficacy and safety of ranibizumab combined with laser photocoagulation treatment versus laser monotherapy in NPDR and PDR patients with diabetic macular oedema.
Lang, GE, Liakopoulos, S, Vögeler, J, Weiß, C, Spital, G, Gamulescu, MA, Lohmann, C, Wiedemann, P
Acta ophthalmologica. 2018;(3):e377-e385
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PURPOSE To assess efficacy and safety of intravitreal ranibizumab 0.5 mg plus laser (COMBI) versus laser monotherapy (LASER) in patients with visual impairment due to diabetic macular oedema (DME) in either nonproliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) and to analyse the relevance of inner versus outer retinal thickness. METHODS In this double-masked, multicentre phase IIIb study, patients (N = 128) were randomized (2:1) to receive COMBI (n = 85) versus LASER (n = 43). Patients received four initial monthly injections of ranibizumab 0.5 mg (COMBI) or sham (LASER) followed by pro re nata (PRN) injections. In both groups, patients received laser at baseline and additional laser at 3 monthly intervals, as needed. The study was started in 2010 and was prematurely terminated due to approval of ranibizumab for DME. RESULTS The least squares (LS) mean change in mean best-corrected visual acuity (BCVA) from baseline to month 12 was higher in the COMBI (6.5) versus LASER (2.3) group (LS mean difference: 4.2 [95% CI 0.9; 7.4] letters, p = 0.01, primary end-point). There was also a tendency in the same direction for the subgroup of 26 patients with PDR (LS mean difference 14.7, p = 0.11). Mean central retinal thickness decreased by 107.3 μm in the COMBI group and by 80.3 μm in the LASER group from baseline to month 12 (p = 0.28). Ranibizumab was well tolerated. CONCLUSION This study showed that ranibizumab plus laser is a valuable treatment option for the management of DME. Patients with DME in PDR might also benefit from combined therapy compared to laser alone.
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Diabetic macular edema: Evidence-based management.
Browning, DJ, Stewart, MW, Lee, C
Indian journal of ophthalmology. 2018;(12):1736-1750
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Diabetic macular edema (DME) is the most common cause of vision loss in patients with diabetic retinopathy with an increasing prevalence tied to the global epidemic in type 2 diabetes mellitus. Its pathophysiology starts with decreased retinal oxygen tension that manifests as retinal capillary hyperpermeability and increased intravascular pressure mediated by vascular endothelial growth factor (VEGF) upregulation and retinal vascular autoregulation, respectively. Spectral domain optical coherence tomography (SD-OCT) is the cornerstone of clinical assessment of DME. The foundation of treatment is metabolic control of hyperglycemia and blood pressure. Specific ophthalmic treatments include intravitreal anti-VEGF drug injections, intravitreal corticosteroid injections, focal laser photocoagulation, and vitrectomy, but a substantial fraction of eyes respond incompletely to all of these modalities resulting in visual loss and disordered retinal structure and vasculature visible on SD-OCT and OCT angiography. Efforts to close the gap between the results of interventions within randomized clinical trials and in real-world contexts, and to reduce the cost of care increasingly occupy innovation in the social organization of ophthalmic care of DME. Pharmacologic research is exploring other biochemical pathways involved in retinal vascular homeostasis that may provide new points of intervention effective in those cases unresponsive to current treatments.