# NAC Attack, a phase-3, multicenter, randomized, placebo-controlled trial with retinitis pigmentosa: OCT Reading Center

> **NIH NIH UG1** · DUKE UNIVERSITY · 2024 · $259,193

## Abstract

Abstract
The objective of the activities proposed in this application is to provide spectral-domain optical
coherence tomography (SD-OCT) Reading Center support to the NAC Attack study. This project's
primary goal is to identify by OCT the effect of N-acetyl cysteine (NAC) compared to control
treatment on progression of retinitis pigmentosa from baseline to study end, as assessed by the
cumulative loss in foveal-centered ellipsoid zone (EZ) length. An exploratory goal is to determine
NAC's effect, when compared to control, on the cumulative loss of the EZ area.
The primary and exploratory objectives will be accomplished through the following specific aims:
Specific Aim 1: Provide the infrastructure to process SD-OCT images submitted by NAC Attack
clinical sites to the OCT Reading Center.
Specific Aim 2: Train and certify NAC Attack clinical site personnel on methods to acquire and
transmit images to the OCT Reading Center.
Specific Aim 3: Provide Reliable, Timely, Reproducible, and Systematic Grading of submitted
SD-OCT.
To achieve these aims, we will use in-house developed, validated, and 21 CFR 21-compliant
stand-alone web-based systems to provide secure methods for clinical sites to transmit electronic
SD-OCT data to the OCT Reading Center, to store and back-up submitted data, assign the
images to be graded to Reader, and to provide electronic data entry forms into which Readers
will enter their image quality assessment data. Readers will use our custom-developed and
validated software to manually grade the foveal EZ length and automatically quantify the EZ area
in the assigned images. The foveal EZ length and EZ area data will be exported directly from
software into a database that will be transferred to the Coordinating Center through a secure
portal. The OCT Reading Center will also implement materials and methods for Reader and
clinical site OCT technician certification and training, rigorous quality control for manual and
automatic gradings, and support study goals as an image resource for recruitment, Study Group
meetings, presentations, and publications.

## Key facts

- **NIH application ID:** 10808922
- **Project number:** 5UG1EY033287-03
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Sina Farsiu
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $259,193
- **Award type:** 5
- **Project period:** 2022-03-17 → 2027-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10808922

## Citation

> US National Institutes of Health, RePORTER application 10808922, NAC Attack, a phase-3, multicenter, randomized, placebo-controlled trial with retinitis pigmentosa: OCT Reading Center (5UG1EY033287-03). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10808922. Licensed CC0.

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