SOW.docx

Statement of Work Statement of Work

INTRODUCTION/OVERVIEW

Government (Unit on Clinical Investigation of Retinal Disease, DECA, NEI) requires independent reading center services in support of a retrospective data analysis, in order to obtain data and analyses resulting from grading of optical coherence angiography images.

EVALUATION CRITERIA

Evaluation will consist of a rating of the vendor’s ability to meet the terms and conditions imaging grading.

SCOPE

This scope of work is based on a discussion occurring May 2020. Changes to the assumptions will impact the scope of work and budget.

OBJECTIVES

Optical coherence tomography angiography is a relatively new imaging modality which enables the assessment of flow through both retinal and choroidal blood vessels non-invasively. The role of the choriocapillaris (CC) is critical to the understanding of many disease of the outer retina, most notably age-related macular degeneration (AMD). The CC is separated from the retina pigment epithelium (RPE) by Bruch’s membrane, and any sub-RPE deposits that accompany the retina disease. The CC supplies the metabolic needs of the RPE and photoreceptors and removes metabolic waste. In AMD, changes to the CC may underly the progression of “dry” AMD and the progression of AMD. Two studies, the “Longitudinal Investigation of Dark Adaptation in Participants with Age-Related Macular Degeneration- protocol 11EI0147” and the AREDS2 have OCTA imaging acquired in the context of AMD. Analyzing the OCTA for area of flow-voids and other metrics of choroidal dysfunction is critical to understanding the pathobiology of AMD. A reading center that has expertise for conducting such analyses is critical to the understanding of the role of the choroid in AMD. The technical aspects of OCTA analyses are many, especially with spectral domain OCTA. Utilizing a reading center with expertise in analyzing both SD-OCTA and swept-source OCTA in the setting of AMD is paramount for obtaining meaningful metrics.

REQUIREMENTS

TASKS:

STUDY START UP (INITIATION PHASE)

· The budget does not include an in-person or investigator meeting.

· Provide a dedicated project manager to coordinate startup activities and maintain study timelines.

· Develop Analysis Charter to document study roles, responsibilities, workflow and evaluation questions.

STUDY MAINTENANCE (ONGOING PHASE)

· Check-in and review of all study submissions, which includes:

· Quality assessment of imaging

· Evaluation of OCT and OCTA for quantitative assessment of defined outcomes.

· OCTA – Angioplex (and Plexelite when available) for quantitation of choroidal vascular density

· OCT – Macular scans for evaluation of retinal pathology including but not limited to drusen volume quantification

STUDY CLOSEOUT (COMPLETION PHASE)

· Provide final data export as an excel spreadsheet

DELIVERABLES

Data from analysis of images as defined in the assumptions below.

SCHEDULE

· All changes to the scope will be submitted in writing to the contractor

· Grading data will be exported at set intervals throughout the study

ASSUMPTIONS

· Imaging is well-underway; thus, no certification of technicians and equipment will be completed by the FPRC.

· 135 participants from DA study, total, with variable number of follow-up visits.

· ~200 participants from ARED2 study with a single study visit.

· Images will be received via online box

· Analysis of optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) images for up to 135 DA participants for up to 4 visits per participant (variable follow-up)

· Analysis of optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) images for up to 200 AREDS2 participants

GOVERNMENT FURNISHED PROPERTY

· N/A

SECURITY REQUIREMENTS

· N/A