Transcript Funding Mechanism
Vitrectomy Outcomes in Eyes with Diabetic Macular Edema, Visual Loss, and Vitreomacular Traction Sponsored by the National Eye Institute, National Institutes of Health, U.S. Department of Health and Human Services.
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Rationale: Vitrectomy for DME
Case series report resolution of DME and improving VA
Most series not prospective, many in preOCT era
Possible positive impacts:
Anatomic resolution of vitreomacular tractional forces
Physiologic changes: improved oxygenation or beneficial changes in retinal microenvironment 2
Rationale for Prospective Cohort Study
Lack of investigator equipoise: surgery indicated in eyes with VMT and reduced VA
Cohort study: Prospective data collection, standardized protocol
Data provide reference for future surgical trials 3
Overall Study Design
Prospective Cohort Study At least one eye meeting all of the following criteria :
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DME on clinical exam BCVA letter score > 20/400 Presence of vitreomacular traction associated with macular edema OR judgment that edema will not to respond to focal/grid photocoagulation Vitrectomy performed by the investigator’s usual routine
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Follow-up and Treatment Schedule
Vitrectomy Intraop/Postop Data and Complications Collected 3 Month Follow-Up 6 Month Follow-Up
BCVA
OCT
7-field photos at 6 mos 6
Main Outcomes: 6 months
Visual acuity
Retinal thickening on OCT
Complications 7
ARVO Report: Primary Cohort
Investigator states that vitreomacular traction was reason for vitrectomy
Visual acuity 20/63 to 20/400
Central subfield >300 microns on OCT
Cataract extraction not performed during vitrectomy 8
Results
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Study Enrollment
241 eyes enrolled and underwent vitrectomy for DME at 35 clinical sites
Indication for surgery VMIA: 227 eyes
87 eyes in primary cohort
Vitreomacular traction
VA 20/63 to 20/400
OCT CSF >300 microns
Cataract extraction not performed 10
Visit Completion
Primary Cohort (n=87)
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98% at 3-month visit 96% at 6-month visit 11
Baseline Characteristics Primary Cohort (n=87) Median Age Women (%) White (%) Diabetes Type (%): Type I /Type 2 Median Visual Acuity Median OCT CSF thickness 66 years 45% 79% 16%/ 84% 20/100 491 microns 12
Baseline Characteristics Continued Primary Cohort Retinopathy Severity NPDR PDR Pseudophakic Epiretinal Membranes Present No Probable Definite 31% 64% 57% 24% 22% 49% 13
Baseline Characteristics Continued Primary Cohort Status of vitreous on clinical examination Attached Partially attached Detached 56% 32% 6% 6% Uncertain Reasons for Vitrectomy Vitreomacular interface abnormality 100% Unresponsive to other therapies 31% 14
Surgery Characteristics Primary Cohort (n=87) Vitrectomy System 19/20 gauge 25 gauge Other Epiretinal Membrane Peeled ILM Removed 40% 49% 10% 61% 54% 15
Surgery Characteristics Primary Cohort (n=87) Agents Used to Improve Visualization Triamcinolone ICG Other Laser Used PRP Focal 60% 34% 25% 5% 55% 39% 5% 16
Surgery Characteristics Continued Primary Cohort Cryotherapy Used Corticosteroids Used at Close Intravitreal Peribulbar/Subconj/Sub Tenon’s Posterior Capsulotomy Performed Epiretinal Membranes Present No Probable Definite 8% 64% 43% 40% 8% 39% 15% 46% 17
Visual Results: Vtx for DME
Anatomic: Median decrease in OCT CSF thickening of 153 microns 42% resolution of central DME (CSF ≤250 microns) Two-thirds of eyes had 50% reduction or more
Functional: Visual acuity improved ≥ 10 letters (= 2 lines) in 37% at 6 months VA decreased ≥ 10 lines in 23% at 6 months
600 500 400 300 200 100 0 Primary Outcome: Primary Cohort Mean Retinal Thickness Mean CST Baseline 3 Months 6 Months 19
Primary Outcome: Primary Cohort Change in Retinal Thickness 20
Primary Outcome: Primary Cohort Change in Visual Acuity 100% 80% 60% 40% 20% 0% ≥ +10 +5 - +9 -4 - +4 -9 - -5 ≤ -10 3 month ≥ +10 +5 - +9 -4 - +4 -9 - -5 ≤ -10 6 month 21
Complications 0-6 Months Primary Cohort Operative complications Any postoperative complications/AE – (%) Vitreous Hemorrhage Development of Vitreomacular Interface Abnormalities Elevated IOP Requiring Treatment Retinal Detachment Retinal Tear Endophthalmitis Macular Ischemia Double Vision Other 7% 18% 6% 2% 8% 3% 0 1% 0 2%
Results
4/8 eyes with RD, endophthalmitis, or VH lost 10 or more letters at 6 months
For every 100 microns CSF decrease, improvement in VA 2.6 letters
CSF retinal thickness changes stabilize at 3 months after vitrectomy 23
Follow-up Analysis
1 year data on this cohort
Analysis of the entire cohort of patients with VMT: N=227
Impact on outcomes: pseudophakia, baseline VA, severity of retinopathy, ERM peeling, ILM peeling
Discussion
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Conclusions: DME, Visual Loss, Vitreomac Traction
Marked anatomic improvement:
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153 microns mean CSF decrease
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43% <250 microns at 6 months
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Two-thirds > 50% improvement in CSF thickening
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37% improved by 10 or more letters at 6 mo 22% declined by 10 or more letters at 6 mo 26
Study Limitations
Unknown how these cases would have fared without treatment Judgment that indication for surgery was vitreomacular traction was made by the investigator, not a reading center Variety of surgical maneuvers employed 27
Study Strengths
Standardized protocol across 35 diverse clinical sites in the U.S.
Little loss to follow-up through 6 months
“Real world” scenario: judgment of VMT made by experienced surgeons
Numbers allow subgroup analysis (n=227)
Provides a reference going forward 28
Thank You
35 clinical study sites
Subjects who volunteered to participate in this trial
DRCR Network Data and Safety Monitoring Committee
Juvenile Diabetes Research Foundation (JDRF)
DRCR Network investigators and staff
For further information and all DRCR Network financial disclosures,
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go to www.drcr.net