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Specific Aim 1B for Macular Edema (BabySTEPS Trial)

N/A
Waitlist Available
Led By Cynthia A Toth, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Summary

Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that may impact vision in vulnerable preterm neonates for a lifetime. This study utilizes new technology to determine visual and neurological development of very preterm infants in the intensive care nursery, during a period of rapid growth of the retina, optic nerve and brain. The long-term goal of this study is to help improve preterm infant health care via objective bedside imaging and analysis that characterizes early critical indicators of poor vision, neurological development and ROP, which will rapidly translate to better early intervention and improved future vision care.

Eligible Conditions
  • Macular Edema
  • Retinopathy of Prematurity
  • Neurodevelopmental Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain MRI grading
Initiate ICN research imaging with the novel ultralight hand piece and high speed SSOCT (Aim 1A)
Maximum ROP stage as determined during clinical evaluation
+8 more
Secondary outcome measures
Clinician's decision to treat
Neuroinflammatory marker scores
Presence of non-ROP ocular conditions
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Specific Aim 3Experimental Treatment1 Intervention
Specific Aim 3 (delineate which elements and regions (posterior) or (peripheral) of preterm infant OCT-derived retinal microanatomy best inform us about severity of disease and visual outcomes in infants with ROP will include the same 68 participants plus an additional 42 very preterm infants undergoing evaluation for ROP and visual function but who will not be in the neurodevelopmental study and thus will not have brain MRI, 2-year Bayley Scales testing or neuroinflammatory marker testing on scavenged blood. The Specific Aim 3 subjects will undergo the following: 1. Swept Source OCT imaging of both eyes with the novel ultralight handpiece as described in Aim 2. The axial length of the eye may be measured after the ROP exam. 2. After imaging with the original lens (ultralight handpiece) both eyes will be imaged with the widefield OCT lens. before or after the ROP exam. 3. Ocular and systemic health data will be extracted from the study participant's medical record.
Group II: Specific Aim 2Experimental Treatment3 Interventions
Specific Aim 2 (distinguish elements of retinal microanatomy that predict maldevelopment of visual pathway and poor neurodevelopment that may impact vision in preterm infants) includes 68 very preterm infants undergoing the following during evaluation for ROP. 1. Swept Source OCT imaging of both eyes with the novel ultralight handpiece before or after ROP examination, timed with each examination. The axial length of the eye may be measured after the ROP exam. 2. Non-sedated research brain Magnetic Resonance Imaging will be obtained in 68 participants prior to discharge from the nursery whenever possible (as close to term age as possible). In the case of an early infant discharge to another hospital, every effort will be made to obtain brain MRI prior to transfer or an outpatient non-sedated brain MRI at near term age. 3. Scavenged blood collection: Residual samples of serum/plasma in the laboratory will be collected for neuroinflammatory marker testing.
Group III: Specific Aim 1BExperimental Treatment1 Intervention
Specific Aim 1B (implement technical innovations to improve OCT imaging in non-sedated infants in the ICN: (1B) extend imaging to the vascular-avascular junction via a wide-field lens). Aim 1B only: 50 participants (25 healthy adult volunteers and 25 pediatric participants under going examination under anesthesia * Healthy adult volunteers will have SSOCT imaging of both eyes with the novel ultralight handpiece up to 10 times. * Pediatric participants undergoing examination under anesthesia will have SSOCT imaging of both eyes with the novel ultralight handpiece once during their EUA in the Duke Eye Center Operating Rooms (OR). These participants will be enrolled into the study at DUHS including the Duke Eye Center clinics and OR for testing the custom widefield lens.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Swept Source OCT
2016
N/A
~200

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,065,893 Total Patients Enrolled
4 Trials studying Macular Edema
293 Patients Enrolled for Macular Edema
National Eye Institute (NEI)NIH
551 Previous Clinical Trials
1,406,722 Total Patients Enrolled
44 Trials studying Macular Edema
8,985 Patients Enrolled for Macular Edema
University of PennsylvaniaOTHER
2,053 Previous Clinical Trials
43,012,936 Total Patients Enrolled
~21 spots leftby Sep 2025
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