Dataset Information

Proliferative Diabetic Retinopathy Events in Patients With Diabetic Macular Edema: Post Hoc Analysis of VISTA and VIVID Trials.

ABSTRACT:

Purpose

This work aimed to assess the incidence of proliferative diabetic retinopathy (PDR) events and improvement to mild non-PDR (NPDR) or better after intravitreal aflibercept injection (IAI) or laser treatment (control) in diabetic macular edema (DME).

Methods

PDR events in the VISTA (NCT01363440) and VIVID (NCT01331681) phase 3 clinical trials were evaluated in a combined IAI-treated group (IAI 2 mg every 4 weeks or 2 mg every 8 weeks after 5 initial monthly doses; n = 475) and a macular laser control group (n = 235) through week 100 in eyes without PDR at baseline (Diabetic Retinopathy Severity Scale [DRSS] score ≤ 53). Improvement in the DRSS score to 35 or better was evaluated in those with a baseline DRSS score of 43 or greater.

Results

A lower proportion of eyes in the IAI group than in the laser group developed a PDR event through week 100 (4.4% vs 11.1%; adjusted difference, -6.7%; 97.5% CI, -11.7 to -1.6; nominal P = .0008). All PDR events occurred in eyes with a baseline DRSS score of 43, 47, or 53 and not in those with a score of 35 or less. A greater proportion of eyes in the IAI group than in the control group achieved a DRSS score of 35 or less (20.0% vs 3.8%; nominal P < .0001).

Conclusions

Fewer eyes with NPDR and DME treated with IAI than eyes treated with a laser had a PDR event. More eyes treated with IAI improved to mild NPDR or better (DRSS score ≤ 35) through 100 weeks.

SUBMITTER: Do DV

PROVIDER: S-EPMC9976032 | biostudies-literature | 2022 Jul-Aug

REPOSITORIES: biostudies-literature

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Publications

Proliferative Diabetic Retinopathy Events in Patients With Diabetic Macular Edema: Post Hoc Analysis of VISTA and VIVID Trials.

Do Diana V DV Gordon Carmelina C Suñer Ivan J IJ Reed Kimberly K Moini Hadi H Gibson Andrea A Du Weiming W Shah Chirag P CP

Journal of vitreoretinal diseases 20220604 4

<h4>Purpose</h4>This work aimed to assess the incidence of proliferative diabetic retinopathy (PDR) events and improvement to mild non-PDR (NPDR) or better after intravitreal aflibercept injection (IAI) or laser treatment (control) in diabetic macular edema (DME).<h4>Methods</h4>PDR events in the VISTA (NCT01363440) and VIVID (NCT01331681) phase 3 clinical trials were evaluated in a combined IAI-treated group (IAI 2 mg every 4 weeks or 2 mg every 8 weeks after 5 initial monthly doses; n = 475) a ...[more]

PMID: 37007930

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Project description:ImportanceEffective management of proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME) requires reliable patient follow-up to prevent disease progression.ObjectiveTo investigate the sociodemographic and clinical factors associated with being lost to follow-up (LTFU) among individuals with PDR or DME treated with anti-vascular endothelial growth factor (VEGF) intravitreal injections (IVIs) or panretinal photocoagulation (PRP).Design, setting, and participantsThis cohort study included a multicenter, retrospective review of patients with PDR or DME treated in Toronto, Canada, from January 1, 2012, to December 31, 2021. Data were analyzed from February 1 to May 31, 2024.ExposuresAll patients received at least 1 anti-VEGF IVI or PRP session.Main outcomes and measuresThe primary outcome was the LTFU rate, defined as the absence of an ophthalmic visit or intervention in the 1-year period following an individual's last visit with the treating retinal specialist. Univariable and multivariable logistic regression models were conducted to evaluate associations between sociodemographic and clinical factors with the LTFU rate.ResultsOverall, 2961 patients with PDR or DME (mean [SD] age, 71 [13] years; 1640 [55.4%] male) were included, of whom 507 (17.1%) were LTFU over a mean (SD) follow-up period of 61 (22) months. In the multivariable analysis, older patients (age ≥85 years vs age <65 years: odds ratio [OR], 0.58; 95% CI, 0.40-0.81; P = .002), those with worse baseline visual acuity (>20/200 Snellen vs 20/40 Snellen or better: OR, 0.68; 95% CI, 0.48-0.97; P = .04), those with DME (OR vs no DME, 0.60; 95% CI, 0.43-0.83; P = .003), those with frequent clinic visits (≥6 visits vs <6 visits: OR, 0.78; 95% CI, 0.62-0.98; P = .04), and those with a high anti-VEGF IVI burden in the first year (OR vs low anti-VEGF burden, 0.40; 95% CI, 0.21-0.76; P = .006) were less likely to be LTFU. In contrast, males (OR vs females, 1.23; 95% CI, 1.04-1.52; P = .04), patients living further from the point of care (>200 vs ≤20 km OR, 2.65; 95% CI, 1.85-3.76; P < .001), and those treated with PRP (OR vs anti-VEGF IVIs, 2.10; 95% CI, 1.24-3.55; P < .001) were more likely to be LTFU. Compared with White patients, Black patients (OR, 2.10; 95% CI, 1.50-2.95; P < .001) and Hispanic patients (OR, 1.54; 95% CI, 1.05-2.21; P = .03) were more likely to be LTFU.Conclusions and relevanceThis cohort study found multiple factors associated with LTFU rates. Identifying individuals at higher risk of LTFU and developing targeted strategies may reduce disease progression and vision loss in individuals with PDR.

Project description:BackgroundDiabetic macular edema (DME) shows a gradual and sustained functional and morphologic response to anti-vascular endothelial growth factor (VEGF) drugs, but the optimal schedule for initiation of anti-VEGF therapy is not known. This study evaluates the treatment response behavior of DME in the Phase 3 trials of intravitreal aflibercept, with 5 initial intravitreal aflibercept injections (IAI), 2 mg every 4 weeks (2q4), in the upload phase.MethodsThis post hoc pooled analysis of the VISTA-DME (NCT01363440) and VIVID-DME (NCT01331681) trials evaluated the change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) during the upload phase, using pooled data from both IAI treatment groups [2q4 and 2 mg every 8 weeks (2q8)]. The mean visit-to-visit change in BCVA and CRT, and the respective rate of gainers and losers was calculated for each successive visit. A secondary analysis compared the visit-to-visit change in BCVA between the 2q4 and 2q8 treatment arms during the upload period and the first year treatment period.ResultsThe majority of eyes showed a continuing improvement of BCVA after the first IAI. The proportions of eyes gaining BCVA (≥5 letters) at each visit compared with the previous visit during the IAI 2q4 upload phase were 60 (4-weeks), 19 (8-weeks), 16 (12-weeks), 15 (16-weeks), and 14 % (20-weeks). In contrast, the proportions of eyes losing BCVA (≥5 letters) were 3 (4-weeks), 7 (8-weeks), 7 (12-weeks), 9 (16-weeks), and 8 % (20-weeks), respectively. The odds of BCVA (≥5 letters) gain/loss exceeded 1.7 at each visit (range 1.7-20). Overall, the proportion of patients with BCVA gain ≥5 letters at week 20 (compared with baseline) was 76 and 80 % in the 2q4 and 2q8 groups, respectively. The proportions of eyes showing a visit-to-visit decrease in CRT of ≥30 µm during the first 5 IAI were 77 (4-weeks), 27 (8-weeks), 21 (12-weeks), 17 (16-weeks), and 12 % (20-weeks). In the secondary analysis, the BCVA outcomes were similar for the 2q8 and 2q4 treatment arms.ConclusionsThe data presented here are consistent with continual functional and anatomic improvement following the fourth and fifth initial 2q4 injections, suggesting that an intensive and sufficiently long upload may be beneficial. Trial registration VIVID-DME: Clinicaltrials.gov: NCT01331681; VISTA-DME: Clinicaltrials.gov: NCT01363440.

Project description:ImportancePrevious studies on the relationship between diabetic retinopathy (DR) and cardiovascular disease (CVD) focused on the early stages of DR. Understanding whether patients with type 2 diabetes and severe stages of DR (diabetic macular edema [DME] and proliferative diabetic retinopathy [PDR]) have a higher risk of CVD will allow physicians to more effectively counsel patients.ObjectiveTo examine the association of severe stages of DR (DME and PDR) with incident CVD in patients with type 2 diabetes.Data sourcesEnglish-language publications were reviewed for articles evaluating the relationship of DR and CVD in MEDLINE, EMBASE, Current Contents, and the Cochrane Library from inception (January 1, 1950) to December 31, 2014, using the search terms diabetic retinopathy OR macular edema AND stroke OR cerebrovascular disease OR coronary artery disease OR heart failure OR myocardial infarction OR angina pectoris OR acute coronary syndrome OR coronary artery disease OR cardiomyopathy.Study selectionAmong 656 studies screened for eligibility, 7604 individuals were included from 8 prospective population-based studies with data on photographic-based DR grading, follow-up visits, and well-defined incident CVD end point.Data extraction and synthesisTwo independent reviewers conducted a systematic search of the 4 databases, and a single pooled database was developed. Incidence rate ratios (IRRs) were estimated for patients with DME, PDR, and vision-threatening DR, compared with persons without these conditions, by using individual participant data followed by a standard inverse-variance meta-analysis (2-step analysis). The review and analyses were performed from January 1, 2009, to January 1, 2017.Main outcome and measuresIncident CVD, including coronary heart disease, stroke, or death from cardiovascular causes.ResultsAmong 7604 patients with type 2 diabetes, the prevalence of DME was 4.6% and PDR, 7.4%. After a mean follow-up of 5.9 years (range, 3.2-10.1 years), 1203 incident CVD events, including 916 coronary heart disease cases, were reported. Persons with DME or PDR were more likely to have incident CVD (IRR, 1.39; 95% CI, 1.16-1.67) and fatal CVD (IRR, 2.33; 95% CI, 1.49-3.67) compared with those without DME or PDR.Conclusions and relevancePatients with type 2 diabetes and DME or PDR have an increased risk of incident CVD, which suggests that these persons should be followed up more closely to prevent CVD.

Project description:PurposeTo study the association between different hypoglycemic regimens and postoperative diabetic macular edema (DME).MethodsA secondary analysis based on a retrospective cohort study.ResultsIn this secondary analysis, 124 eyes from patients with proliferative diabetic retinopathy (PDR) who underwent pars plana vitrectomy (PPV) between January 2008 and September 2012 were included. We found that compared with oral hypoglycemic medication, oral hypoglycemic medication plus insulin treatment revealed an insignificant relationship with postoperative DME (odds ratio [OR]=0.8, 95% confidence interval [CI]: 0.12-5.21, P=0.8167), only insulin treatment revealed a significant association with postoperative DME (OR=0.10, 95% CI: 0.01-0.84, P=0.0337) after adjusted age, sex. After adjusted age, sex, diabetes mellitus (DM) duration, glycosylated hemoglobin (HbA1c), the results did not have obvious changes (OR=0.61, 95% CI: 0.09-4.26, P=0.6187; OR=0.07, 95% CI: 0.01-0.65, P=0.0197). Furthermore, after adjusted age, sex, DM duration, HbA1c, hypertension, intraoperative retinal photocoagulation, vitreous hemorrhage, macular detachment, fibrovascular membrane, intraocular lens implantation and microincision vitrectomy surgery, the results were consistent (OR=0.66, 95% CI: 0.05-9.49, P=0.7621; OR=0.06, 95% CI: 0.00-0.81, P=0.0342). The same trend was observed in these adjusted models as well (p for trend was 0.0254, 0.0141, and 0.0311, respectively).ConclusionIn conclusion, our results of the secondary analysis should be interpreted as a significant association between insulin treatment and reduced risks of postoperative DME in Japanese PDR patients with PPV surgery, compared with oral medications. Well glycemic control with longstanding insulin therapy may be beneficial to reduce the risks of postoperative DME in PDR patients. Our investigation calls for large-scale and long-term prospective clinical studies for a full evaluation of the exact role of insulin in the progression of postoperative DME.

Project description:ImportanceThe comorbidity of chronic kidney disease and diabetic retinopathy (DR) is well known. However, to our knowledge, no cohort study has demonstrated the effect of chronic kidney disease on the development or progression of DR.ObjectiveTo investigate the association of chronic kidney disease with the development of DR and diabetic macular edema (DME) in type 2 diabetes.Design, setting, and participantsThis 8-year prospective cohort study that was conducted in 2 medical centers in Taiwan included 2135 patients with type 2 diabetes.ExposuresThe baseline and mean follow-up renal profiles including serum creatinine level, estimated glomerular filtration rate (eGFR), and urinary albumin/creatinine ratio (ACR).Main outcomes and measuresDiabetic retinopathy and DME were detected with nonmydriatic fundus photography. Cox regression analyses was used to evaluate the hazard ratios (HRs) for the renal profiles of new-onset DR, proliferative DR, and DME.ResultsThe mean (SD) age of the study participants was 63.4 (11.9) years and 1025 (48%) were women. A higher serum creatinine level (HR of 2.358 for an increase of 1 mg/dL [to convert to micromoles per liter, multiply by 76.25]; 95% CI, 1.901-2.924; P < .001), an estimated glomerular filtration rate of less than 60 mL/min/1.73m2 (40-60: HR, 2.235; 95% CI, 1.351-4.035; P = .002; 30-45: HR, 2.625; 95% CI, 1.436-4.798; P = .002; <30: HR, 5.488; 95% CI, 2.739-10.993; P < .001), and a urinary albumin to creatinine ratio (ACR) of more than 30 mg/g (31-300: HR, 3.202; 95% CI, 2.029-5.053; P < .001; >300: HR, 6.652; 95% CI, 3.922-11.285; P < .001) at baseline were all associated with the development of proliferative DR. A baseline urinary ACR of more than 30 mg/g (31-300: HR, 1.563; 95% CI, 1.078-2.267; P = .02; >300: HR, 2.707; 95% CI, 1.640-4.470; -2.707; P < 0.001) was associated with the development of DME. After adjusting the baseline values, the mean follow-up renal profiles, including a higher serum creatinine level (HR, 2.369 per mg/dL; 95% CI, 1.704-3.293; P < .001), an estimated glomerular filtration rate of less than 30 mL/min/1.73m2 (HR, 4.215; 95% CI, 1.265-14.039; P = .02), and a urinary ACR of more than 30 mg/g (31-300: HR, 2.344; 95% CI, 1.200-4.503; P = .01; >300: HR, 4.193; 95% CI, 1.638-10.735; P = .003) were still correlated with new-onset PDR during the follow-up periods.Conclusions and relevanceAbnormal renal profiles at baseline, including a high serum creatinine level, low estimated glomerular filtration rate, and high urinary ACR, were associated with the development of PDR in patients with type 2 diabetes. A high baseline urinary ACR was associated with DME. Abnormal mean follow-up renal profiles were still correlated with new-onset PDR after adjusting for baseline values. Aggressive treatment for chronic kidney disease may have a role in preventing the deterioration of DR.

Dataset Information

Proliferative Diabetic Retinopathy Events in Patients With Diabetic Macular Edema: Post Hoc Analysis of VISTA and VIVID Trials.

Purpose

Methods

Results

Conclusions

Publications

Proliferative Diabetic Retinopathy Events in Patients With Diabetic Macular Edema: Post Hoc Analysis of VISTA and VIVID Trials.

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