October 2006
CComplications ofomplications ofAAge-related Macular ge-related Macular Degeneration Degeneration PPreventionreventionTTrialrial
Sponsored by the National Eye InstituteSponsored by the National Eye Institute
CComplications ofomplications ofAAge-related Macular ge-related Macular Degeneration Degeneration PPreventionreventionTTrialrial
Sponsored by the National Eye InstituteSponsored by the National Eye Institute
October 2006
Study QuestionStudy Question Study QuestionStudy Question
Can low-intensity Can low-intensity macular laser macular laser treatment reduce treatment reduce the incidence of the incidence of vision loss in vision loss in eyes with large eyes with large drusendrusen??
October 2006
Design SummaryDesign SummaryDesign SummaryDesign Summary
Major Eligibility Criteria – > 10 large drusen
(>125) in each eye– Visual acuity
>20/40 in each eye– Age > 50 years– No other ocular
disease
October 2006
Design SummaryDesign Summary
Randomization SchemeRandomization Scheme
CAPT Eligible PatientCAPT Eligible Patient
Randomization of eyesRandomization of eyes
One EyeTreated
One EyeObserved
5Initial Treatment (1500-2500 µ)
Barely visible burns60 burns15 burns/quadrant 100 µ burns0.1 second1500-2500 µ
2500 µ 1500 µ
6
October 2006
Design SummaryDesign Summary Design SummaryDesign Summary
• Sample Size: 1052 people Sample Size: 1052 people
2104 eyes2104 eyes
Length of Follow-Up: Length of Follow-Up: ≥≥5 years 5 years
October 2006
Design SummaryDesign Summary Design SummaryDesign Summary
Outcome Measures Outcome Measures PrimaryPrimary
Change in visual acuityChange in visual acuity SecondarySecondary
Incidence of Advanced AMD Incidence of Advanced AMD (CNV, GA, SPED)(CNV, GA, SPED)
Contrast thresholdContrast thresholdReading (critical print size)Reading (critical print size)Side effects of treatmentSide effects of treatment
October 2006
Description of Follow-upDescription of Follow-up Description of Follow-upDescription of Follow-up
• Overall missed visits:Overall missed visits: 3%3%
• 87% of the 1052 patients 87% of the 1052 patients completed the 5-year examinationcompleted the 5-year examination
9% patient deaths9% patient deaths
4% missed the 5-year exam4% missed the 5-year exam
October 2006
Percentage of Eyes with 50% Percentage of Eyes with 50% Reduction of Baseline Drusen by Reduction of Baseline Drusen by
Treatment GroupTreatment Group
19%
34% 37%41% 42%
46%
1% 3%9%
16%
25%
31%36%
14%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
6 12 24 36 48 60 72
Months of Follow-up
Treated
Observed
October 2006
Percentage of Eyes with Visual Percentage of Eyes with Visual Acuity Loss of Three Acuity Loss of Three LinesLines or or
MoreMore
3%5%
10%
15%
21%
24%
2% 3%
6%
13%
16%
21%
24%
2%
0%
10%
20%
30%
6 12 24 36 48 60 72
Months of Follow-up
Treated
Observed
October 2006
Incidence of AdvancedIncidence of Advanced Age-related Macular Age-related Macular
DegenerationDegeneration
0%
5%
10%
15%
20%
25%
30%
0 6 12 18 24 30 36 42 48 54 60 66 72 78
Months of Follow-up
Treated
Observed
p=0.51
20%
October 2006
Incidence of Choroidal Incidence of Choroidal NeovascularizationNeovascularization
0%
5%
10%
15%
20%
25%
30%
0 6 12 18 24 30 36 42 48 54 60 66 72 78
Months of follow-up
Treated
Observed
P=0.95
13%
October 2006
Incidence of Geographic Incidence of Geographic AtrophyAtrophy
0%
5%
10%
15%
20%
25%
30%
0 6 12 18 24 30 36 42 48 54 60 66 72 78
Months of follow-up
..
Treated
Observed
P=0.64
7.5%
October 2006
VA Loss – All PatientsVA Loss – All Patients
• Mean VA score Mean VA score Baseline:Baseline: 20/25 20/25(+2)(+2)
5 years:5 years: 20/40 20/40(+3)(+3)
Mean loss Mean loss ~~ 2 lines 2 lines
• Eyes with 20/20 or betterEyes with 20/20 or betterBaseline:Baseline: 50% 50%
5 years:5 years: 31% 31%
October 2006
VA Loss at 5 Years by Advanced VA Loss at 5 Years by Advanced AMD Status and Treatment AMD Status and Treatment
GroupGroup
Advanced AMD Advanced AMD ≥ 3 Line Loss≥ 3 Line Loss
at 5 Yearsat 5 Years Treated Treated ObservedObserved
PresentPresent 60% 60%54%54%
AbsentAbsent 10% 10%11%11%
October 2006
Secondary Vision OutcomesSecondary Vision Outcomes5-Year Results from CAPT5-Year Results from CAPT
24%
30%
21%
28%
0%
5%
10%
15%
20%
25%
30%
35%
Contrast Needed Doubled Reading Print Size Doubled
Treated
Observed
October 2006
Adverse EventsAdverse Events
• No immediate complications of No immediate complications of treatment at either initial or 12-treatment at either initial or 12-month treatment month treatment
(burns to foveal avascular zone, breaks in (burns to foveal avascular zone, breaks in Bruch’s membrane, hemorrhage)Bruch’s membrane, hemorrhage)
• Loss of Loss of ≥6 lines of VA ≥6 lines of VA notnot due to due to AMD or cataractAMD or cataract
Treated eyes:Treated eyes: 0.6%0.6%Observed eyes: Observed eyes: 1.3%1.3%
October 2006
SummarySummary
• Treated and observed eyes were very Treated and observed eyes were very similar at 5 years after enrollment on:similar at 5 years after enrollment on:3-line loss in VA3-line loss in VAIncidence of Advanced AMD (CNV & Incidence of Advanced AMD (CNV &
GA)GA)Change in contrast thresholdChange in contrast thresholdChange in critical print sizeChange in critical print sizeAdverse eventsAdverse events
• Laser treatment as applied in CAPT had Laser treatment as applied in CAPT had no clinically significant beneficial or no clinically significant beneficial or harmful effectharmful effect
October 2006
5-Year Results from CAPT5-Year Results from CAPT
21%
13%
7%
24%
30%
21%
13%
8%
21%
28%
0%
5%
10%
15%
20%
25%
30%
35%
3 or MoreLine Loss in
VisualAcuity
DevelopedCNV
DevelopedGeographic
Atrophy
ContrastNeededDoubled
ReadingPrint SizeDoubled
TreatedUntreated
October 2006
Principal Investigators of Principal Investigators of Clinical CentersClinical Centers
• Donald W. Park, MD Mesa, AZ
• Robert N. Johnson, MD San Francisco, CA
• Peter Reed Pavan, MD Tampa, FL
• Baker Hubbard III, MD Atlanta, GA
• Alice Lyon, MD Chicago, IL
• David Orth, MD Harvey, IL
• James C. Folk, MD Iowa City, IA
• Charles C. Barr, MD Louisville, KY
• Jeffrey Heier, MD Boston, MA
• Susan B. Bressler, MD Baltimore, MD
October 2006
Principal Investigators of Principal Investigators of Clinical CentersClinical Centers
• Michael Trese, MD Royal Oak, MI
• Colin A. McCannel, MD Rochester, MN
• Gilbert Grand, MD St. Louis, MO
• Andrew N. Antoszyk, MD Charlotte, NC
• Steven R. Leff, MD Edison, NJ
• Lawrence J. Singerman, MD Cleveland, OH
• Frederick H. Davidorf, MD Columbus, OH
• Richard F. Dreyer, MD Portland, OR
• Michael L. Klein, MD Portland, OR
• Juan E. Grunwald, MD Philadelphia, PA
• Gary Edd Fish, MD Dallas, TX
• Suresh R. Chandra, MD Madison, WI
October 2006
CAPT Resource Centers at the University of Pennsylvania
• Chairman’s OfficeStuart L. Fine, MD
• Reading CenterJudith Alexander
• Coordinating Center Maureen G. Maguire, PhD
October 2006
AppendixAppendix
October 2006
Serous PED Without Apparent Serous PED Without Apparent CNVCNV
• Not commonNot common2 treated eyes2 treated eyes5 untreated eyes5 untreated eyes
• Included as part of Advanced AMDIncluded as part of Advanced AMD
October 2006
Prophylactic Treatment of AMD Prophylactic Treatment of AMD (PTAMD) Multi-Centered Trial - (PTAMD) Multi-Centered Trial -
DesignDesign
• Bilateral Study reported by Friberg at Bilateral Study reported by Friberg at ARVO 2006ARVO 2006
• Eligibility criteriaEligibility criteria
≥≥5 drusen ≥635 drusen ≥63 microns in each eye microns in each eye
VA VA ≥20/63≥20/63
• Randomized assignment of one eye to a Randomized assignment of one eye to a single treatment of 48 subthreshold single treatment of 48 subthreshold diode laser burns at initial visitdiode laser burns at initial visit
• 639 patients (1278 eyes) enrolled639 patients (1278 eyes) enrolled
October 2006
PTAMD – Overall ResultsPTAMD – Overall Results
• CNV incidence CNV incidence
No difference between treated and No difference between treated and observed eyes at 3 yearsobserved eyes at 3 years
• Mean VA at 2 yearsMean VA at 2 years
Treated eyes 1.5 letters better than Treated eyes 1.5 letters better than observed (p=0.04) observed (p=0.04)
• Percentage with Percentage with ≥2 line VA gain at 2 ≥2 line VA gain at 2 yearsyears
12% Treated vs 8% Observed12% Treated vs 8% Observed
October 2006
PTAMD – PTAMD – SubgroupSubgroup Results Results
• Eyes with initial VA 20/32 to 20/63 (n=?)Eyes with initial VA 20/32 to 20/63 (n=?)
• At 2 yrsAt 2 yrs TreatedTreated ObservedObserved
≥≥2 line gain:2 line gain: 31% 31% 19% p=0.02 19% p=0.02
≥≥2 line loss: 13% 2 line loss: 13% 22% p=0.04 22% p=0.04
• CAPT subgroup: initial VA 20/32-20/40 in 1 or both CAPT subgroup: initial VA 20/32-20/40 in 1 or both eyes (n= 385) at 2 yrseyes (n= 385) at 2 yrs
≥≥2 line gain: 7% 2 line gain: 7% 5% 5%
≥≥2 line loss: 11% 2 line loss: 11% 14% 14%
• CAPT subgroup at 5 yrsCAPT subgroup at 5 yrs
≥≥2 line loss: 33% 2 line loss: 33% 33% 33%
29
Initial Visit 12 Months
Observed Eye - <50% Drusen Reduction at 12 months
30
Initial Visit 12 Months
Observed Eye - <50% Drusen Reduction at 12 months
31
Observed Eye - <50% Drusen Reduction at 12 months
Initial Visit 12 Months
32
Observed Eye - <50% Drusen Reduction at 12 months
Initial Visit 12 Months
33
Observed Eye - >50% Drusen Reduction at 12 months
Initial Visit 12 Months
34
Observed Eye - >50% Drusen Reduction at 12 months
Initial Visit 12 Months
35
Initial Visit 12 Months
Treated Eye - <50% Drusen Reduction at 12 months
36
Initial Visit 12 Months
Treated Eye - <50% Drusen Reduction at 12 months
37
Initial Visit 12 Months
Treated Eye - <50% Drusen Reduction at 12 months
38
Treated Eye - >50% Drusen Reduction at 12 months
Initial Visit 12 Months
39
Treated Eye - >50% Drusen Reduction at 12 months
Initial Visit 12 Months
40
Treated Eye - >50% Drusen Reduction at 12 months
Initial Visit 12 Months
41
Treated Eye - >50% Drusen Reduction at 12 months
Initial Visit 12 Months
42
Treated Eye - >50% Drusen Reduction at 12 months
Initial Visit 12 Months
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