內(nèi)容參考原稿5.back up en eyekor slides for barbara-afternoon session

1、University of WisconsinFundus Photograph Reading CenterBarbara Blodi, MDMedical DirectorPANDAKHB-1801/KHB-1802Investigator Meeting PI Break-Out SessionFundus Photograph Reading CenterDr. Barbara Blodi , MDMedical DDr. Amitha Domalpally, MDResearch DElig

2、ibilityMust have reading center eligibility confirmation prior to randomizationTurnaround goal from FPRC to site is 3 business daysDouble evaluation of eligibility submissionsIneligible subjects reviewed by FPRC ophthalmologists (MD)Imaging Inclusion CriteriaSubfoveal or juxtafoveal CNV secondary to

3、 AMD (including polypoidal choroidal vasculopathy)Active CNV demonstrated by subfoveal FA leakage or subfoveal fluid on SD-OCTInclusion Criteria continuedAdequate QualityInclusion Criteria continuedAdequate QualityCNV 50% of total lesion areaTotal lesion 50% of total lesion areaTotal lesion 1DAInclu

4、sion Criteria continuedAdequate QualityCNV 50% of total lesion areaTotal lesion 1DAAbsence of subfoveal atrophy or fibrosisInclusion Criteria continuedAdequate QualityCNV 50% of total lesion areaTotal lesion 1DAAbsence of subfoveal atrophy or fibrosisAbsence of fibrosis 50% of the lesionInclusion Cr

5、iteria continuedAdequate QualityCNV 50% of total lesion areaTotal lesion 1DAAbsence of subfoveal atrophy or fibrosisAbsence of fibrosis 50% of the lesionAbsence of any confounding abnormalities (RPE tear, full thickness hole, other disease process)Eligible exampleSubfoveal CNV Subfoveal leakage with

6、 FA Subfoveal fluid with OCTEligible exampleJuxtafoveal CNV No subfoveal leakage with FA Subfoveal fluid with OCTIneligible- absence of leakage or fluidJuxtafoveal CNV No subfoveal leakage with FA No subfoveal fluid with OCTInteractive Case DiscussionCase 1Case 1- EligibleSubfoveal CNV Subfoveal lea

7、kage with FA No Subfoveal fluid with OCTCase 2Case 2- EligibleSubfoveal CNV Subfoveal leakage with FA No Subfoveal fluid with OCTCase 3Case 3- EligibleJuxtafoveal CNV No subfoveal leakage with FA Subfoveal fluid with OCTCase 4Case 4- Ineligible- Subfoveal fibrosisCase 5Case 5- Eligible Juxtafoveal C

8、NV Subfoveal leakage with FA Subfoveal fluid with OCTCase 6 Case 6- Ineligible- SPED 50% of lesion, Lesion 12 DACase 7Case 7- Ineligible- Hemorrhage 50% of lesionEligibility notificationAn eligibility confirmation will be available in the BioClinica IxRS systemAn email will be sent from Contact your

9、 Syneos monitor if you have any questionsThe Reading Center eligibility is only part of the assessment and further checks must be completed before patient randomizationReading Center Eligibility25-30% submissions ineligibleTop 3 reasons for ineligibilityNO subfoveal activity Fibrous scar SizeSummarySmall lesionSubfoveal CNV activityPredominantly CNVFew non CNV componentsSummaryActive, subfoveal or juxtafoveal CNV due to AMDDouble review at readin