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Diabetic retinopathy. Juan G. Santiago, MD Valley Retina Institute, P.A. Introduction. Epidemiology Pathophysiology Classification Diabetic Retinopathy Diabetic Macular Edema Clinical Trials DRS ETDRS DCCT UKPDS Intro to Treatment. DM in America. 24 million (8%) Americans

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diabetic retinopathy

Diabetic retinopathy

Juan G. Santiago, MD

Valley Retina Institute, P.A.

introduction
Introduction
  • Epidemiology
  • Pathophysiology
  • Classification
    • Diabetic Retinopathy
    • Diabetic Macular Edema
  • Clinical Trials
    • DRS
    • ETDRS
    • DCCT
    • UKPDS
  • Intro to Treatment
dm in america
DM in America
  • 24 million (8%) Americans
    • ~18 million diagnosed
    • ~6 million undiagnosed
    • 5-10% with type 1 diabetes
  • 57 million with pre-diabetes
  • 25% > 60 yrs of age with DM

*  National Diabetes Fact Sheet, 2007

the diabetes epidemic
The Diabetes Epidemic
  • Significant increase in the incidence of diabetes during the last decade
    • 1.6 million new cases (aged ≥20 yrs) per year
  • Increase across all regions, demographic groups, ages, genders, racial/ethnic groups and subpopulations
diabetic retinopathy prevalence
Diabetic Retinopathy Prevalence
  • WESDR
    • ~ 50.3% of DM patients have DR of any type
  • UKPDS (newly diagnosed Type 2 DM)
    • ~ 40% with DR at entrance into study
diabetic retinopathy1
Diabetic Retinopathy

Leading cause of PREVENTABLE new-onset blindness in working-age population

systemic risk factors for progression of dr
Systemic Risk Factors for Progression of DR
  • Poor glycemic control
  • Hypertension
  • Renal Disease
  • Dyslipidemia
  • Anemia
  • Abdominal Obesity
  • Eating Disorders
  • Gastroparesis
  • Pregnancy
vision loss from diabetes
Vision Loss From Diabetes
  • Vitreous Hemorrhage
  • Tractional Retinal Detachment
  • Diabetic Macular Edema
  • Neovascular Glaucoma
  • Ischemic Maculopathy
pathophysiology of dr
Pathophysiology of DR
  • Fundamental cause – Uncertain
  • Relative hypoxia
  • Biochemical changes / Glucose mediated microvascular changes (PKC, advanced glycation end products, VEGF)
  • Compromised neuroretinal function
  • Inflammation – “diabetic retinitis”
  • Glucose excess / insulin deficiency
pathophysiologic processes of dr
Pathophysiologic Processes of DR
  • Loss of pericytes associated with retinal capillaries
  • Thickening of the basement membrane
  • Changes in retinal blood flow
  • Outpouching of capillary walls to form MA’s
  • Closure of retinal capillaries and arterioles leading to retinal nonperfusion
  • Breakdown of the blood / retinal barrier with increased vascular permeability of retinal capillaries
  • Proliferation of new retinal and/or iris vessels
  • Development of fibrovascular tissue
  • Contraction of vitreous and fibrous proliferation with subsequent VH and/or RD as a result of traction
retinal signs of hypoxia
Retinal Signs of Hypoxia
  • Cotton wool spots
    • 1/1 correlation with retinal ischemia
  • Venous caliber abnormalities
    • Change in course / dimention / direction of vessel
    • Venous beading
  • Venous tortuosity
  • Arteriolar abnormalities
  • IRMA
    • 70% of NV occurs in areas of IRMA
  • Featureless retina
featureless retina
Featureless Retina
  • Lack of H/Ma and IRMA
  • Reduced small arteriole branches
  • “Pruning” of capillaries
  • Opaque retinal appearance
pdr at 1 year visit by severity of lesion
PDR at 1-Year Visit, by severity of lesion

ETDRS Report 12. Ophthalmology 1991

diabetic changes in macular structure
Diabetic Changes in Macular Structure
  • Macular Edema
  • Nonperfusion
  • Traction
  • Intraretinal or Pre-retinal Hemorrhage
  • Lamellar or Full-Thickness Hole Formation
  • Combination of above
no diabetic retinopathy
No Diabetic Retinopathy
  • No clinical signs of DR
  • Early biochemical changes and changes in retinal blood flow
  • Nondiabetic changes and complications may be present
mild nonproliferative dr
Mild Nonproliferative DR
  • At least one microaneurysm
  • Criteria not met for more severe levels of DR
    • H/Ma < 2A in all 4 quadrants

Standard Photo 2A

PDR (1 yr): 5% HR-PDR (5yr): 15%

moderate nonproliferative dr
Moderate Nonproliferative DR
  • H/Ma ≥ standard photo 2A in 1-3 retinal quadrants or
  • Soft exudates, venous beading, or IRMA definitely present
  • Criteria not met for more severe levels o DR

Standard Photo 2A

PDR (1 yr): 12-27% HR-PDR (5yr): 33%

severe nonproliferative dr
Severe Nonproliferative DR

The 4-2-1 Rule

  • H/Ma ≥ standard 2A in all 4 retinal quadrants or
  • Venous beading in 2 or more retinal quadrants or
  • IRMA ≥ standard 8A in a least quadrant
  • Criteria not met for more severe levels of DR

Standard Photo 8A

PDR (1 yr): 52% HR-PDR (5yr): 60%

very severe nonproliferative dr
Very Severe Nonproliferative DR
  • Any 2 or more criteria of Severe NPDR
  • Criteria not met for more severe DR

Standard Photo 6B

PDR (1 yr): 75% HR-PDR (5yr): 75%

high risk proliferative dr
High Risk Proliferative DR
  • NVD ≥ standard 10A (¼ - 1/3 DA)
  • NVD < standard 10A with fresh preretinal or vitreous hemorrhage
  • NVE ≥ ½ DA with fresh preretinal or vitreous hemorrhage

Standard Photo 10A

clinically significant macular edema
Clinically Significant Macular Edema
  • Macular edema that involves or threatens the center of the macula
  • CSME can be present with any level of DR
clinically significant macular edema1
Clinically Significant Macular Edema
  • Retinal thickening at or within 500 um from the center of the macula
  • Hard exudates at or within 500 um from the center of the macula if accompanied by thickening of the adjacent retina
  • A zone of retinal thickening, 1 disc area or larger in size, located 1 disc diameter or less from the center of the macula
international clinical dr and dme disease severity scales
International Clinical DR and DME Disease Severity Scales
  • No apparent DR No abnormalities
  • Mild NPDR Microaneurysm only
  • Moderate NPDR More than Ma only but less than severe NPDR
  • Severe NPDR Any of the following: >20 intraretinal hemorrhages, definite VB in ≥ 2 quadrants, prominent IRMA in ≥ 1 quadrant and no PDR
  • PDR One or more of: NV, VH, PRH

Ophthalmology. September 2003

international clinical dr and dme disease severity scales1
International Clinical DR and DME Disease Severity Scales
  • DME apparently absent No apparent retinal thickening or HE in posterior pole
  • DME apparently present Some apparent retinal thickening or HE in posterior pole
    • Mild DME – some retinal thickening or HE in posterior pole but distant from center of the macula (ETDRS: DME but not CSME)
    • Moderate DME – retinal thickening or HE approaching the center of the macula but not involving the center (ETDRS: CSME)
    • Severe DME – retinal thickening or HE involving the center of the macula (ETDRS: CSME)

Ophthalmology. September 2003

clinical trials of diabetic retinopathy
Clinical Trials of Diabetic Retinopathy

THE SCIENCE BEHIND THE CARE

Diabetic Retinopathy Study (DRS): 1971-1975

Early Treatment DRS (ETDRS): 1979 – 1990

Diabetes Control and Complications Trial (DCCT) /

Epidemiology of Diabetes Interventions and Complications (EDIC):

1983 – Present

United Kingdom Prospective Diabetes Study (UKPDS): 1977-1999

diabetes control and complications trial dcct
Diabetes Control and Complications Trial (DCCT)
  • Eligibility – Type 1 Diabetes: Age 13-39 yr
    • No retinopathy or mild-moderate NPDR
  • Randomization– 1441 patients
    • Primary prevention: DM 1-5 yr; no DR
    • Secondary intervention: DM 1-15 yr; mild-mod DR
    • Conventional vs. intensive blood glucose control
  • Endpoints
    • Development/progression of diabetic retinopathy
    • Neuropathy/nephropathy outcomes
dcct results type 1 dm
DCCT Results – Type 1 DM

Primary prevention

Secondary prevention

  • Intensive control
    • 27% Reduction in development of DR
    • 78% Reduction in progression of DR
  • Intensive control
    • 54% reduction in progression of DR
    • 47% reduction in PDR and severe NPDR
    • 56% reduction in photocoagulation
    • 23% reduction in macular edema
epidemiology of diabetes interventions and complications edic 1994 present
Epidemiology of Diabetes Interventions and Complications (EDIC): 1994 - Present
  • 1375 of the 1441 patients from the DCCT
  • Retinopathy, renal function and glycemic control monitored according to DCCT protocol
  • Assessed A1c levels and retinal and renal complications after the end of the DCCT
do benefits of intensive glycemic control persist after period of intensive control
Do Benefits of Intensive Glycemic Control Persist after Period of Intensive Control?
  • Seven years after intensive glycemic control:
    • 75% risk reduction in progression of DR
    • 69% risk reduction in PDR or severe NPDR
    • 58% risk reduction in DME
    • 52% risk reduction in need for laser
can intensive glycemic control totally prevent the development of dr
Can intensive glycemic control totally prevent the development of DR?
  • Intensive control does NOT totally prevent the development of DR, but reduces risk of developing any DR by 27%
are some stages of dr too severe to benefit from intensive glycemic control
Are some stages of DR too severe to benefit from intensive glycemic control?
  • No, but intensive control is most effective with earlier DR
    • 65% reduction in progression of DR
    • 47% reduction in developing severe NPDR
    • 48% reduction in developing PDR
    • 29% reduction in developing DME
ukpds
UKPDS

Type 2 Diabetes

Intensive Blood Glucose Control

VS

Conventional Blood Glucose Control

united kingdom prospective diabetes study ukpds
United Kingdom Prospective Diabetes Study (UKPDS)
  • Eligibility – Type 2 Diabetes
    • Enrolled at diagnosis of diabetes
  • Randomization – 4209 patients
    • Primary prevention
    • Secondary intervention
    • Conventional vs. intensive blood glucose control
  • Endpoints
    • Development/progression of diabetic retinopathy
    • Neuropathy/nephropathy/cardiovascular outcomes
ukpds summary
UKPDS Summary
  • Intensive blood glucose control resulted in statistically significant reduction in
    • 29% reduction in need for laser
    • 17% reduction in progression of DR
    • 24% reduction in need for cataract extraction
    • 23% reduction in vitreous hemorrhage
    • 16% reduction in legal blindness
dcct edic ukpds conclusions
DCCT, EDIC, UKPDSConclusions
  • Implement intensive therapy as early as possible
  • Maintain intensive therapy for as long as possible
diabetic retinopathy study
Diabetic Retinopathy Study
  • Major design features
    • One eye of each patient assigned randomly
      • Scatter PRP vs. Local
      • Argon laser vs. Xenon Arc
    • Other eye
      • F-up without photocoagulation
diabetic retinopathy study1
Diabetic Retinopathy Study
  • Major conclusions
    • Photocoagulation reduced risk of SVL by ≥50%
    • Modest risks
      • ↓ VA (1 line)
      • Constriction of VF (xenon > argon)
    • Treatment benefit outweighs risks for eyes with HR-PDR
      • 50% 5-year rate of SVL in such eyes without treatment reduced to 20% by treatment
early treatment diabetic retinopathy study etdrs
Early Treatment Diabetic Retinopathy Study (ETDRS)
  • Eligibility – Type 1 or Type 2 Diabetes
    • Mild NPDR through early PDR
  • Randomization – 3711 patients
    • Early vs. Deferred Scatter (Panretinal) Laser Photocoagulation
    • Focal laser photocoagulation for macular edema vs. no treatment
    • 650 mg Aspirin vs. Placebo
  • Endpoints
    • VA ≤ 5/200 for at least 4 months
    • Doubling of initial visual angle (e.g. 20/40 to 20/80)
    • Progression of retinopathy
etdrs results
ETDRS Results
  • 650 mg aspirin/day
    • Did not alter progression of retinopathy
    • Did not increase risk of vitreous hemorrhage
    • Did not affect vision
    • Did not alter rate of CE
etdrs results1
ETDRS Results
  • Focal laser for CSME
    • Decreased risk of moderate visual loss
    • Caused occasional moderate visual gain
    • Decreased retinal thickening
  • Early Scatter Laser
    • Small reduction in risk of severe visual loss
    • Benefit of early treatment more pronounced for patients with type 2 DM or patients with type 1 DM of long duration
management for diabetic retinopathy
Management for Diabetic Retinopathy
  • Awareness
  • Prevention
  • Screening
  • Early diagnosis / Fundus FA
  • Intensive glycemic control (DCCT/EDIC, UKPDS)
  • Control of concurrent systemic disorders
    • Hypertension (UKPDS)
    • Hyperlipidemia (ETDRS)
    • Abdominal Obesity (Eurodiab)
    • Anemia (ETDRS)
  • Laser Treatment
  • Vitrectomy
treatment program for dr
Treatment Program for DR
  • Initial scatter laser photocoagulation as the DR approaches or reaches the high risk stage
  • Careful follow-up at 3-4 months interval following the treatment
  • Re-treatment of persistent or recurrent treatable lesions
  • Focal laser photocoagulation to reduce the risk of progression of macular edema secondary to scatter photocoagulation
today therapeutic modalities
Today Therapeutic Modalities
  • Steroids – Intravitreal, implant, peribulbar
  • Macugen, Avastin, Lucentis, VEGF-Trap
  • Gene Therapy
  • PKC Inhibitors, GH/IGF-1 Inhibitors, Anti-AGEs
  • Anti-Oxidants, Aldose Reductase Inhibitors
  • Neuroprotectants, Vitreolysis
  • Combination Therapy
  • Novel Targets
tomorrow
Tomorrow
  • Determine basic mechanisms of disease
  • Identify potential therapeutics targets
  • Develop specific novel therapies
  • Evaluate at subcellular, cellular & organism level
  • Rigorous clinical trials
  • Opportunity to make today’s standard of care obsolete tomorrow
recommended initial retinal exam and follow up frequency
Recommended Initial Retinal Exam and Follow-up Frequency
  • Type 1 DM
    • Within 5 years of diagnosis or at puberty
    • Annually thereafter
  • Type 2 DM
    • Upon diagnosis
    • Annually thereafter
  • Pregnancy
    • Before planned pregnancy
    • Early in each trimester
    • 6-8 weeks post partum