NCT04995341: BabySTEPS2

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Recruiting now NA Last updated 6 October 2025

What this trial tests

NA trial testing Investigational ultracompact OCT and OCTA system in Retinopathy of Prematurity in 236 participants. Currently enrolling.

Timeline

16 August 2021

Primary endpoint
31 March 2026

31 March 2026

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	double
Primary purpose	other
Enrollment	236
Start date	16 August 2021
Primary completion	31 March 2026
Estimated completion	31 March 2026
Sites	2 locations across United States

Drugs / interventions tested

• Investigational ultracompact OCT and OCTA system
• retinal photographs

Conditions studied

• Retinopathy of Prematurity — all drugs for Retinopathy of Prematurity →

Sponsor

Duke University

Who can join

Eligibility, any sex, with Retinopathy of Prematurity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preterm infant retinal OCT markers of perinatal health and retinopathy of prematurity.
   Mangalesh S, Toth CA. · · 2023 · cited 5× · PMID 37808559 · DOI 10.3389/fped.2023.1238193
2. Biphasic change in retinal nerve fibre layer thickness from 30 to 60 weeks postmenstrual age in preterm infants.
   Shen LL, Mangalesh S, McGeehan B, Seely KR, et al · · 2023 · cited 4× · PMID 36113954 · DOI 10.1136/bjo-2022-321621
3. Early Single-Examination Optical Coherence Tomography Biomarkers for Treatment-Requiring Retinopathy of Prematurity.
   Chen X, Mangalesh S, He J, Winter KP, et al · · 2024 · cited 2× · PMID 38591938 · DOI 10.1167/iovs.65.4.21