An observational study in Retinopathy of Prematurity (ROP) and ROP Examination, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 24 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Vanderbilt University Medical Center · Observational
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Among 51 studies in Retinopathy of Prematurity with a site in United States — 6 open to participants now, 10 under way, none of them phase 3. Retinopathy of Prematurity · United States.
Among the 51 studies in Retinopathy of Prematurity with a site in United States, this one is the 10th largest by planned enrollment of the 15 observational ones that give a count, is the only one that started in 2025, is one of 15 observational ones, and was the 47th registered.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
Browse Retinopathy of Prematurity studies →6 of the 51 studies in Retinopathy of Prematurity with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 0 days–9 mo
FELIQS INC. · Sites in United States
Ages 4 days–5 days
Duke University · Sites in United States
Ages up to 2 mo
Duke University · Sites in United States
Healthy volunteers
Oregon Health and Science University · Sites in United States
Ages up to 1 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 19 Retinopathy of Prematurity studies recruiting now, 7 (37%) set no upper age limit and 12 (63%) stop at 75 or younger; 19 take children under 18; 4 take healthy volunteers.
This study: 24 Weeks to 34 Weeks · all sexes · no healthy volunteers.
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51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 13 · Phase 3 11 · Phase 4 1
First in 1986; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is below the median of 175 across 57 observational studies indexed under Retinopathy of Prematurity.
Median enrollment 114 across the 32 interventional studies, 102 across the 15 observational. Of the 35 that completed or were terminated, 14 (40%) have results posted.
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12 of 51 have an industry lead sponsor. The 10 most frequent:
Vanderbilt University Medical Center is the lead sponsor of 835 studies on the registry; 155 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 92 (73%) have results posted.
Vanderbilt University Medical Center has 1 study filed under Retinopathy of Prematurity — fewer than ten, so there is no comparison to draw.
3 of the studies in Retinopathy of Prematurity with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07093255FELIQS INC.Safety, PK and PD of FLQ-101 in Premature Neonates | 2026-12-31 |
| NCT04995341Duke UniversityRetinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) | 2027-03-31 |
| NCT05558059Duke UniversityImaging Retinal Vasculature in Infant Eyes | 2027-08-31 |
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Among the 51 studies in Retinopathy of Prematurity with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. Furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.
Imaging studies using HH-SECTR will be performed to assess and quantify structural and vascular disease features associated with ROP. Weekly HH-SECTR imaging will be performed concurrently with standard-of-care weekly ROP screening. No additional treatments will be given to study patients to benefit HH-SECTR imaging (e.g., sedation, dilation, etc.). Study patients will primarily be imaged in the NICU, but may also be performed under sedation or anesthesia in the operating room concurrent with standard-of-care exams. Because this study will evaluate diagnostic features prognostic of ROP progression and severity, HH-SECTR imaging will be performed until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first. Both eyes will undergo HH-SECTR imaging. Diagnostic imaging data will be analyzed following each imaging session. No experimental data will be used to alter the management of patients from the standard-of-care.
Research materials obtained from subjects will include digital HH-SECTR images, digital fundus photography images, and documented examination timeline as part of the standard-of-care. Patient medical records will be used to determine eligibility to participate in the study and will be used as the source documents for following post-examination clinical variables.
The duration of the study will be 5 years. The study records and information will be indefinitely archived per NIH rules using the methods noted above.
Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth.
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Exclusion Criteria:
Retinal imaging in pediatric ROP patients
Real-time noninvasive optical imaging of the retina will be performed out to the ora serrata and ROP diagnostic markers will be evaluated in post-processing and compared against clinical examination
Time frame: Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first
Started Feb 2025 (actual). Primary completion is estimated for Feb 2029, 48 months after the start.
Of 25 observational studies under Retinopathy of Prematurity, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 48 months is above that.
How these figures are worked out, and which studies are left out of them.
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Vanderbilt University Medical Center →