Condition (MeSH)
Retinopathy of Prematurity
ClinicalTrials.gov lists 166 trials for Retinopathy of Prematurity or a narrower condition beneath it. NICHD Neonatal Research Network has the most among industry and government lead sponsors, with 5.
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Trials per phase
1 more section with rows
166 of the 166 trials are tagged with Retinopathy of Prematurity itself; the rest are tagged with a narrower condition beneath it.
When did Retinopathy of Prematurity trials start? (28)
Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 1 trial is registered to start in 2027 or later, and not listed here.
Trials over time, by phase
- Phase 1
- Phase 1/2
- Phase 2
- Phase 2/3
- Phase 3
- Phase 4
- Not applicable
- Observational
Top of scale: 15
Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.
| Year | Trials started |
|---|---|
| 2026 (partial year) | 6 |
| 2025 | 3 |
| 2024 | 14 |
| 2023 | 8 |
| 2022 | 12 |
| 2021 | 15 |
| 2020 | 8 |
| 2019 | 10 |
| 2018 | 4 |
| 2017 | 3 |
Showing 10 of 28 earlier years.
Forecast of the full-year count, planned starts included, not rows of this table: about 7 trials starting in 2026 and about 7 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.
Prediction, not a registry value: median of 32 months from start to primary completion across 8 trials still running at the 2026-10-09 snapshot; registered median of 24 months across 110 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
What phase are Retinopathy of Prematurity trials in? (9)
Shown in this order: phase order.
Show the trials by phase as a table
| Phase | Trials |
|---|---|
| Phase 1 | 6 |
| Phase 1/2 | 4 |
| Phase 2 | 16 |
| Phase 2/3 | 6 |
| Phase 3 | 16 |
| Phase 4 | 11 |
| Not applicable | 47 |
| Observational | 59 |
| Expanded access | 1 |
How many Retinopathy of Prematurity trials are recruiting? (8)
Shown in this order: the order a trial moves through, from not yet recruiting to unknown.
| Status | Trials |
|---|---|
| Not yet recruiting | 6 |
| Recruiting | 15 |
| Active, not recruiting | 5 |
| Completed | 97 |
| Terminated | 10 |
Showing 5 of 8 statuses.
Status as registered on ClinicalTrials.gov. Each trial is counted once.
Which lead sponsors run the most Retinopathy of Prematurity trials? (5)
Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.
| Sponsor | Trials |
|---|---|
| NICHD Neonatal Research Network | 5 |
| Bayer | 4 |
| Novartis Pharmaceuticals | 4 |
| National Eye Institute (NEI) | 3 |
| Siloam Vision | 3 |
Which drugs are being tested for Retinopathy of Prematurity? (1)
Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.
| Drug | Trials |
|---|---|
| Sucrose | 2 |
Interventions as named in the registry (14)
Shown in this order: most trials first.
| Drug | Trials |
|---|---|
| Bevacizumab 1 | 9 |
| ranibizumab PRN | 8 |
| 2.0 aflibercept | 5 |
| Propranolol PO | 5 |
| Double distilled water | 2 |
Showing 5 of 14 interventions.
These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.
Which serious adverse events do Retinopathy of Prematurity trials report? (10)
Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.
| Adverse event | Subjects affected | Trials |
|---|---|---|
| Patent Ductus Aretriosus | 631 | 1 |
| Death | 239 | 2 |
| Intraventricular hemorrhage (IVH) Grade 3 or 4 | 164 | 1 |
| Necrotizing enterocolitis | 146 | 1 |
| Air leak during initial 14 days | 93 | 1 |
Showing 5 of 10 adverse events.
Which publications cover Retinopathy of Prematurity? (357)
Shown in this order: major-topic papers first, then newest, then most linked to trials.
| Publication | Journal | Year | Major topic |
|---|---|---|---|
| Cerebral injury and retinopathy as risk factors for blindness in extremely preterm infants. | Archives of disease in childhood. Fetal and neonatal edition | 2025 | Yes |
| Efficacy and Safety of Mydriatic Microdrops for Retinopathy of Prematurity Screening: The MyMiROPS Randomized Clinical Trial. | JAMA ophthalmology | 2025 | Yes |
| Combined dietary omega-3 and omega-6 fatty acids protect against hyperglycemia-associated retinopathy in neonatal mice. | Pharmacological research | 2025 | Yes |
| Cord blood transfusions in extremely low gestational age neonates to reduce severe retinopathy of prematurity: results of a prespecified interim analysis of the randomized BORN trial. | Italian journal of pediatrics | 2024 | Yes |
| Development of a joint set of database parameters for the EU-ROP and Fight Childhood Blindness! ROP Registries. | The British journal of ophthalmology | 2024 | Yes |
Showing 5 of 357 publications.
Prevalence (3)
Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.
| Orphanet disease | Type | Class | Geography | Jurisdiction | Mapping relation |
|---|---|---|---|---|---|
| Retinopathy of prematurity | Point prevalence | 1-5 / 10 000 | Europe | Not stated | Exact |
| Retinopathy of prematurity | Point prevalence | 1-5 / 10 000 | Europe | Not stated | Unspecified |
| Retinopathy of prematurity | Point prevalence | 1-5 / 10 000 | Europe | Not stated | Exact |
Rare-disease identity (2)
Shown in this order: exact, broader, narrower, other.
| Orphanet disease | ORPHA code | Relation | Source |
|---|---|---|---|
| Retinopathy of prematurity | 90050 | Exact | Orphadata Science knowledge files, Product 1 |
| Retinopathy of prematurity | 90050 | Exact | Orphanet Rare Disease Ontology (ORDO) |
Not on this page
Not measured: delivery record.
Checked, with nothing recorded for this condition: sub-conditions in mesh.