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The Diabetic Retinopathy Clinical Research Network

The Diabetic Retinopathy Clinical Research Network. Observational Study of Subclinical Diabetic Macular Edema

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The Diabetic Retinopathy Clinical Research Network

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  1. The Diabetic Retinopathy Clinical Research Network Observational Study of Subclinical Diabetic Macular Edema Supported through a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services EY14231, EY14229, EY018817 

  2. Background • Diabetic macular edema (DME) is a common cause of visual loss in people with diabetes. • Clinical diagnosis of DME via ophthalmoscopy is supplemented frequently by imaging the macula with OCT.

  3. Background • The role of OCT in identifying eyes with diabetic retinopathy in which clinical examination does not identify DME has not been determined. • Subclinical DME: • The situation in which macular thickening is present on OCT, yet thickening is not seen on clinical exam. • It is not known if there is value in identifying subclinical DME.

  4. Observational Study of Subclinical Diabetic Macular Edema: Study Objective Determine how often eyes with subclinical DME have an increase in OCT-measured center point thickness (CPT) of at least 50 µm and a thickness of at least 300 µm or receive treatment for DME during a 2-year follow-up period.

  5. Study Design Observational, multi-center clinical trial At least 1 eye meeting all of the following criteria: • Best corrected E-ETDRS visual acuity letter score ≥74 (~20/32 or better) • Normal central macular thickness on fundus exam • OCT- measured CPT on Zeiss Stratus 225 to 299 µm • No DME threatening the center of the macular for which treatment was anticipated • Mild NPDR (level 35) or higher on clinical exam Primary outcome Cumulative probability of eyes that met either of the following: 1) increase in OCT CPT of ≥50 µm and a CPT of ≥300 µm at either the 1 or 2-year visits OR 2) treatment for DME prior to 2 years

  6. Follow-up Schedule Baseline • Study eyes were followed for 2 years or until the primary outcome was met • Tests performed at each visit: • E-ETDRS Visual Acuity • Clinical assessment for the presence of center-involved DME using slit lamp biomicroscopy • OCT fast macular map scans centered on the fovea • Stereoscopic fundus photographs 1 Year 2 Years

  7. Study Enrollment Eyes Screened = 1226 (613 Study Participants) Eyes Enrolled = 106 (68 Study Participants) Eyes Eligible = 44 (40 Study Participants) 1 Year Visit: N = 38 12 met primary outcome 2 Year Visit: N = 25 4 met primary outcome

  8. Results

  9. Baseline Characteristics

  10. Baseline Characteristics *Based on Reading Center grading of fundus photos. The 2 eyes with diabetic retinopathy absent and the 2 eyes with minimal diabetic retinopathy are the 4 eyes from the companion study that had subclinical DME at baseline and at least mild non-proliferative diabetic retinopathy detected by the enrolling investigator on clinical examination.

  11. Eyes Meeting Primary Outcome

  12. Change in OCT Center Point Thickness from Baseline to the 2-Year Visit or Last Visit According to Baseline Thickness Stratified by Primary Outcome Status N = 35 *Missing OCT data for 9 eyes: 6 eyes are missing all follow-up data; 3 eyes had a follow-up visit but an OCT was not performed prior to treatment. One study participant did not have a 2-year visit and data from the 1-year visit was used.

  13. Cumulative Probability and 95% Confidence Interval of Meeting the Primary Outcome by the 2-Year Follow-up Visit

  14. Visual Acuity for Eyes Meeting Primary Outcome *3 eyes were treated prior to obtaining visual acuity or OCT and are missing data; 2 of the 3 occurred prior to 1 year and the other occurred after 1 year and prior to 2 years (OCT CPT at the 1 year visit was 299 µm)

  15. OCT Center Point Thickness for Eyes Meeting Primary Outcome *3 eyes were treated prior to obtaining visual acuity or OCT and are missing data; 2 of the 3 occurred prior to 1 year and the other occurred after 1 year and prior to 2 years (OCT CPT at the 1 year visit was 299 µm)

  16. OCT Central Subfield Thickness for Eyes Meeting Primary Outcome *3 eyes were treated prior to obtaining visual acuity or OCT and are missing data; 2 of the 3 occurred prior to 1 year and the other occurred after 1 year and prior to 2 years (OCT CPT at the 1 year visit was 299 µm)

  17. Discussion

  18. Conclusions • Approximately 25% to 50% of eyes with subclinical DME will progress to more definite thickening or be judged to need treatment for DME within 2 years. • The number of eyes which have a substantial decrease in visual acuity when progression occurs is not precise • About 8% to 69%

  19. Conclusions • Subclinical was identified uncommonly • 44 eyes (4%) of the 1226 eyes screened were enrolled • Screening for subclinical DME involving the center of the macula does not seem warranted for most eyes. • If subclinical DME is identified: • many eyes will progress to more definitive thickening of the center of the macula or be judged to need treatment for DME within 1 year.

  20. Thank You on Behalf of Diabetic Retinopathy Clinical Research Network (DRCR.net) • 19 clinical study sites • Study participants who volunteered to participate in this trial • DRCR.net Data and Safety Monitoring Committee • DRCR.net investigators and staff 20

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