Dataset Information

Determinants in Initial Treatment Choice for Diabetic Macular Edema.

ABSTRACT:

Purpose

To assess how patient choices (out-of-pocket costs, insurance plan, geographic region) impact initiation of therapy for diabetic macular edema (DME).

Design

Retrospective cohort study using administrative medical claims data from a large, national insurer.

Participants

All patients newly diagnosed with DME from 2013 through 2016 were observed for 90 days after diagnosis or until first treatment was received.

Methods

Multivariate logistic regression was used to create odds ratios comparing different baseline demographic and patient-related factors.

Main outcome measures

The primary outcome was the odds of receiving the different possible initial treatments for DME (anti-vascular endothelial growth factor [VEGF], focal laser treatment, steroids, or observation), no treatment, and not following up.

Results

Of the 6220 newly diagnosed DME patients, 3010 (48.4%) underwent a follow-up examination within 90 days of diagnosis, and of those, 1453 patients (48.3%) received treatment in the observation window, including 614 (20.4%) with bevacizumab, 191 (6.3%) with ranibizumab or aflibercept, 560 (18.6%) with focal laser, 38 (1.3%) with steroid injection, and 50 (1.7%) with an injection of an unspecified drug. Having a copay (vs. $0) lowered the odds of receiving any treatment (odds ratio [OR] = 0.60; 95% confidence interval [CI], 0.51-0.71; P < 0.001) and of receiving each treatment individually (anti-VEGF treatment: OR = 0.72; 95% CI, 0.59-0.88; bevacizumab: OR = 0.73; 95% CI, 0.59-0.91; ranibizumab or aflibercept: OR, 0.70; 95% CI, 0.49-0.99; focal laser: OR = 0.44; 95% CI, 0.35-0.55; P < 0.001). Contrary to having a copay, having a high deductible and type of insurance plan were not associated with initiating treatment (P > 0.41 for all comparisons). Patients in the Northeast showed lower odds of initiating anti-VEGF treatment (OR = 0.60; 95%CI, 0.44-0.82; P < 0.001) and specifically bevacizumab (OR = 0.47; 95% CI, 0.33-0.67; P < 0.001). Furthermore, Northeast patients who were treated with anti-VEGF showed a higher odds of receiving ranibizumab or aflibercept compared with bevacizumab (OR = 2.39; 95% CI, 1.31-4.37; P < 0.001). Southern Midwest patients showed a higher odds of treatment (anti-VEGF: OR = 1.35; 95%CI, 1.02-1.77; P < 0.001; bevacizumab: OR = 1.40; 95% CI, 1.04-1.87; focal laser: OR = 1.39; 95% CI, 1.01-1.89; P < 0.001).

Conclusions

Patient choices such as copays and where they live are important factors in determining the initial choice of treatment for DME.

SUBMITTER: VanderBeek BL

PROVIDER: S-EPMC6875609 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Determinants in Initial Treatment Choice for Diabetic Macular Edema.

VanderBeek Brian L BL Scavelli Kurt K Yu Yinxi Y

Ophthalmology. Retina 20190525 1

<h4>Purpose</h4>To assess how patient choices (out-of-pocket costs, insurance plan, geographic region) impact initiation of therapy for diabetic macular edema (DME).<h4>Design</h4>Retrospective cohort study using administrative medical claims data from a large, national insurer.<h4>Participants</h4>All patients newly diagnosed with DME from 2013 through 2016 were observed for 90 days after diagnosis or until first treatment was received.<h4>Methods</h4>Multivariate logistic regression was used t ...[more]

PMID: 31345726

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Project description:PurposeAssess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial.DesignMulticenter cohort study.ParticipantsParticipants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion).MethodsParticipants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit.Main outcome measuresAnti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST).ResultsSixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0-12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3-14.5) better than baseline but 4.8 letters (95% CI, 2.5-7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4-5.0) better than baseline but 4.6 letters (95% CI, 3.1-6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142-166) and was stable between 2 and 5 years (-1 μm; 95% CI, -12 to 9).ConclusionsAmong the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches.

Project description:The prevalence of persistent diabetic macular edema (DME) after months of anti-vascular endothelial growth factor therapy and its effect on visual acuity are unknown.To assess subsequent outcomes of eyes with DME persisting for 24 weeks after initiating treatment with 0.5 mg of ranibizumab.We performed post hoc, exploratory analyses of a randomized clinical trial from March 20, 2007, through January 29, 2014, from 117 of 296 eyes (39.5%) randomly assigned to receive ranibizumab with persistent DME (central subfield thickness ?250 ?m on time domain optical coherence tomography) through the 24-week visit.Four monthly intravitreous injections of ranibizumab and then as needed per protocol.Cumulative 3-year probabilities of chronic persistent DME (failure to achieve a central subfield thickness <250 ?m and at least a 10% reduction from the 24-week visit on at least 2 consecutive study visits) determined by life-table analyses, and at least 10 letter (?2 line) gain or loss of visual acuity among those eyes.The probability of chronic persistent DME among eyes with persistent DME at the 24-week visit decreased from 100% at the 32-week visit to 81.1% (99% CI, 69.6%-88.6%), 55.8% (99% CI, 42.9%-66.9%), and 40.1% (99% CI, 27.4%-52.4%) at the 1-, 2-, and 3-year visits, respectively. At 3 years, visual acuity improved in eyes with and without chronic persistent DME through the follow-up period, respectively, by a mean of 7 letters and 13 letters from baseline. Among 40 eyes with chronic persistent edema through 3 years, 17 (42.5%) (99% CI, 23.1%-63.7%) gained 10 letters or more from baseline, whereas 5 (12.5%) (99% CI, 2.8%-31.5%) lost 10 letters or more from baseline.These data suggest less than half of eyes treated for DME with intravitreous ranibizumab have persistent central-involved DME through 24 weeks after initiating treatment. Among the 40% that then have chronic persistent central-involved DME through 3 years, longer-term visual acuity outcomes appear to be slightly worse than in the 60% in which DME does not persist. Nevertheless, when following the treatment protocol used in this trial among eyes with vision impairment from DME, long-term improvement in visual acuity from baseline is typical and substantial (?2-line) loss of visual acuity is likely uncommon through 3 years, even when central-involved DME chronically persists.

Project description:Diabetic macular edema (DME) resembles a chronic, low-grade inflammatory reaction, and is characterized by blood-retinal barrier (BRB) breakdown and retinal capillary leakage. Corticosteroids are of therapeutic benefit because of their anti-inflammatory, antiangiogenic, and BRB-stabilizing properties. Delivery modes include periocular and intravitreal (via pars plana) injection. To offset the short intravitreal half-life of corticosteroid solutions (~3 hours) and the need for frequent intravitreal injections, sustained-release intravitreal corticosteroid implants have been developed. Dexamethasone intravitreal implant provides retinal drug delivery for ?6 months and recently has been approved for use in the treatment of DME. Pooled findings (n=1,048) from two large-scale, randomized Phase III trials indicated that dexamethasone intravitreal implant (0.35 mg and 0.7 mg) administered at ?6-month intervals produced sustained improvements in best-corrected visual acuity (BCVA) and macular edema. Significantly more patients showed a ?15-letter gain in BCVA at 3 years with dexamethasone intravitreal implant 0.35 mg and 0.7 mg than with sham injection (18.4% and 22.2% vs 12.0%). Anatomical assessments showed rapid and sustained reductions in macular edema and slowing of retinopathy progression. Phase II study findings suggest that dexamethasone intravitreal implant is effective in focal, cystoid, and diffuse DME, in vitrectomized eyes, and in combination with laser therapy. Ocular complications of dexamethasone intravitreal implant in Phase III trials included cataract-related events (66.0% in phakic patients), intraocular pressure elevation ?25 mmHg (29.7%), conjunctival hemorrhage (23.5%), vitreous hemorrhage (10.0%), macular fibrosis (8.3%), conjunctival hyperemia (7.2%), eye pain (6.1%), vitreous detachment (5.8%), and dry eye (5.8%); injection-related complications (eg, retinal tear/detachment, vitreous loss, endophthalmitis) were infrequent (<2%). Dexamethasone intravitreal implant offers a viable treatment option for DME, especially in cases that are persistent or treatment (anti-vascular endothelial growth factor/laser) refractory.

Dataset Information

Determinants in Initial Treatment Choice for Diabetic Macular Edema.

Purpose

Design

Participants

Methods

Main outcome measures

Results

Conclusions

Publications

Determinants in Initial Treatment Choice for Diabetic Macular Edema.

Similar Datasets

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