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The course of response to focal/grid photocoagulation for diabetic macular edema.

ABSTRACT: The purpose of this study was to determine whether eyes with center-involved diabetic macular edema, treated with focal/grid photocoagulation, in which there is a reduction in central subfield thickness (CST) measured with optical coherence tomography after 16 weeks, will continue to improve if retreatment is deferred.This is a prospective, multicenter, observational, single-group focal/grid photocoagulation study of 122 eyes with center-involved diabetic macular edema (optical coherence tomography CST > or =250 microm). At the 16-week visit and continuing every 8 weeks, eyes were assessed for retreatment and additional laser treatment was deferred if the visual acuity letter score improved > or =5 letters or optical coherence tomography CST decreased > or =10% compared with the visit 16 weeks prior.Of the 115 eyes that completed the 16-week visit, 54 (47%) had a decrease in CST by > or =10% compared with baseline. Of these, 26 (48%) had a CST > or =250 microm at 16 weeks and were evaluable at 32 weeks. Eleven (42%; 95% confidence interval, 23-63%) of the 26 eyes had a further decrease in CST > or =10% from 16 weeks to 32 weeks without further treatment.Sixteen weeks after focal/grid laser for diabetic macular edema in eyes with a definite reduction, but not resolution, of central edema, 23% to 63% likely will continue to improve without additional treatment.

SUBMITTER: Diabetic Retinopathy Clinical Research Network

PROVIDER: S-EPMC2787248 | biostudies-literature | 2009 Nov-Dec

REPOSITORIES: biostudies-literature

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The course of response to focal/grid photocoagulation for diabetic macular edema.

Retina (Philadelphia, Pa.) 20091101 10

<h4>Purpose</h4>The purpose of this study was to determine whether eyes with center-involved diabetic macular edema, treated with focal/grid photocoagulation, in which there is a reduction in central subfield thickness (CST) measured with optical coherence tomography after 16 weeks, will continue to improve if retreatment is deferred.<h4>Methods</h4>This is a prospective, multicenter, observational, single-group focal/grid photocoagulation study of 122 eyes with center-involved diabetic macular ...[more]

PMID: 19898182

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Project description:ObjectiveTo evaluate the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone in comparison with focal/grid photocoagulation for the treatment of diabetic macular edema (DME).DesignMulticenter, randomized clinical trial.ParticipantsEight hundred forty study eyes of 693 subjects with DME involving the fovea and with visual acuity of 20/40 to 20/320.MethodsEyes were randomized to focal/grid photocoagulation (n = 330), 1 mg intravitreal triamcinolone (n = 256), or 4 mg intravitreal triamcinolone (n = 254). Retreatment was given for persistent or new edema at 4-month intervals. The primary outcome was evaluated at 2 years.Main outcome measuresVisual acuity measured with the electronic Early Treatment Diabetic Retinopathy Study method (primary), optical coherence tomography-measured retinal thickness (secondary), and safety.ResultsAt 4 months, mean visual acuity was better in the 4-mg triamcinolone group than in either the laser group (P<0.001) or the 1-mg triamcinolone group (P = 0.001). By 1 year, there were no significant differences among groups in mean visual acuity. At the 16-month visit and extending through the primary outcome visit at 2 years, mean visual acuity was better in the laser group than in the other 2 groups (at 2 years, P = 0.02 comparing the laser and 1-mg groups, P = 0.002 comparing the laser and 4-mg groups, and P = 0.49 comparing the 1-mg and 4-mg groups). Treatment group differences in the visual acuity outcome could not be attributed solely to cataract formation. Optical coherence tomography results generally paralleled the visual acuity results. Intraocular pressure increased from baseline by 10 mmHg or more at any visit in 4%, 16%, and 33% of eyes in the 3 treatment groups, respectively, and cataract surgery was performed in 13%, 23%, and 51% of eyes in the 3 treatment groups, respectively.ConclusionsOver a 2-year period, focal/grid photocoagulation is more effective and has fewer side effects than 1-mg or 4-mg doses of preservative-free intravitreal triamcinolone for most patients with DME who have characteristics similar to the cohort in this clinical trial. The results of this study also support that focal/grid photocoagulation currently should be the benchmark against which other treatments are compared in clinical trials of DME.

Project description:ObjectiveTo compare 2 laser photocoagulation techniques for treatment of diabetic macular edema: the modified Early Treatment Diabetic Retinopathy Study (ETDRS) direct/grid photocoagulation technique and a potentially milder (but potentially more extensive) mild macular grid (MMG) laser technique in which microaneurysms are not treated directly and small mild burns are placed throughout the macula, whether or not edema is present.MethodsTwo hundred sixty-three subjects (mean age, 59 years) with previously untreated diabetic macular edema were randomly assigned to receive laser photocoagulation by either the modified ETDRS (162 eyes) or MMG (161 eyes) technique. Visual acuity, fundus photographs, and optical coherence tomography measurements were obtained at baseline and at 3.5, 8, and 12 months. Treatment was repeated if diabetic macular edema persisted.Main outcome measureChange in optical coherence tomography measurements at 12-month follow-up.ResultsAmong eyes with a baseline central subfield thickness of 250 microm or greater, central subfield thickening decreased by an average of 88 microm in the modified ETDRS group and by 49 microm in the MMG group at 12-month follow-up (adjusted mean difference, 33 microm; 95% confidence interval, 5-61 microm; P = .02). Weighted inner zone thickening by optical coherence tomography decreased by 42 microm in the modified ETDRS group and by 28 microm in the MMG group (adjusted mean difference, 14 microm; 95% confidence interval, 1-27 microm; P = .04); maximum retinal thickening (maximum thickening of the central and 4 inner subfields) decreased by 66 and 39 microm, respectively (adjusted mean difference, 27 microm; 95% confidence interval, 6-47 microm; P = .01), and retinal volume decreased by 0.8 and 0.4 mm3, respectively (adjusted mean difference, 0.3 mm3; 95% confidence interval, 0.02-0.53 mm3; P = .03). At 12 months, the mean change in visual acuity was 0 letters in the modified ETDRS group and 2 letters worse in the MMG group (adjusted mean difference, 2 letters; 95% confidence interval, -0.5 to 5 letters; P = .10).ConclusionsAt 12 months after treatment, the MMG technique was less effective at reducing optical coherence tomography-measured retinal thickening than the more extensively evaluated current modified ETDRS laser photocoagulation approach. However, the visual acuity outcome with both approaches is not substantially different. Given these findings, a larger long-term trial of the MMG technique is not justified.Application to clinical practiceModified ETDRS focal photocoagulation should continue to be a standard approach for treating diabetic macular edema.Trial registrationclinicaltrials.gov Identifier: NCT00071773.

Project description:PurposeThe prevalence of diabetes and diabetes-related complications, including diabetic macular edema (DME), is increasing in Asia and worldwide.MethodsVIVID-East was a 12-month, double-masked, randomized, active-controlled, Phase 3 trial (NCT01783886) enrolling adult patients (aged ≥18 years) with DME at 25 centers across China, Hong Kong, Republic of Korea, and Russia. Eyes were randomized 1:1:1 to 2 mg intravitreal aflibercept (IVT-AFL) every 4 weeks (2q4; N=127), 2 mg IVT-AFL every 8 weeks (after 5 initial monthly doses from baseline to week 16) with sham injections on nontreatment visits (2q8; N=127), or macular laser photocoagulation at baseline and sham injections at every visit (laser control group; N=124). The primary efficacy endpoint was mean change in best corrected visual acuity (BCVA) from baseline to week 52.ResultsCompared with baseline, at week 52 the mean (SE) BCVA in the 2q4 and 2q8 groups gained +13.6 (0.9) and +13.1 (1.0) letters, respectively, versus -0.5 (1.4) letters in the laser group (P<0.0001 for both). A significantly higher proportion of patients treated with IVT-AFL (2q4 and 2q8) achieved a ≥10-letter or ≥15-letter gain compared with laser (both P<0.0001) (≥10-letter gain: 70.9%, 62.7%, and 23.4%, respectively; ≥15-letter gain: 43.3%, 36.5%, and 12.1%, respectively). Mean reduction in central retinal thickness from baseline to week 52 was significantly greater with IVT-AFL versus laser treatment. Incidence of treatment-emergent adverse events was low and similar across groups; conjunctival hemorrhage (11.8%), retinal hemorrhage (8.7%), retinal aneurysm (7.5%), and retinal exudates (5.5%) being the most frequently reported. Visual and anatomic outcomes in the Chinese subgroup were consistent with the overall population.ConclusionIVT-AFL treatment resulted in significant visual and anatomic improvements in Asian patients with DME. Treatment benefits observed in the overall study population were mirrored in the subgroup of Chinese patients, who made up the largest population group in the study.Study registrationNCT01783886.

Project description:IntroductionDiabetes is a common cause of new sight loss in populations world-wide, and diabetic macular edema (DME) is a major cause of visual deficits in the diabetic populations of developed countries. We have performed a meta-analysis to evaluate whether combined treatment with anti-vascular endothelial growth factor (VEGF) injections and macular photocoagulation (MPC) is more efficacious than primary monotherapy with anti-VEGF injections in patients with DME.MethodsWe systematically searched the PubMed and Web of Science databases for studies providing sufficient information for a comparison of pre- and post-treatment of central macular thickness (CMT) and best-corrected visual acuity (BCVA) between two groups of patients with DME given interventional therapies (monotherapy with an anti-VEGF agent vs. combination therapy with an anti-VEGF agent and MPC) before January 2019. A meta-analysis was performed to summarize the results of the studies included in the systematic review.ResultsThe results of our meta-analysis indicated that post-treatment CMT was significantly lower at 3 months in DME patients receiving combination therapy with bevacizumab, a humanized anti-VEGF antibody, and MPC than in those receiving monotherapy with bevacizumab. The results also showed that post-treatment CMT was lower in DME patients given ranibizumab, an anti-VEGF agent, in combination with MPC at 6, 9 and 12 months than in those treated with ranibizumab alone. However, no significant differences were found in post-treatment BCVA at 1, 3, 6, 9 and 12 months between DME patients receiving combination therapy with an anti-VEGF agent (bevacizumab or ranibizumab) and MPC and those receiving monotherapy with an anti-VEGF agent.ConclusionIn conclusion, the results of our meta-analysis demonstrate a transiently synergistic effect of MPC on CMT when this treatment is combined with anti-VEGF agents, whereas no similar synergistic effect could be detected on the BCVA. A relatively longer follow-up was essential to be able to evaluate the long-term existence of this synergistic effect.

Dataset Information

The course of response to focal/grid photocoagulation for diabetic macular edema.

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The course of response to focal/grid photocoagulation for diabetic macular edema.

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