Retinopathy of Prematurity clinical trials
The registry lists 169 studies for Retinopathy of Prematurity across more than 10 countries. 27 are recruiting or about to start. 139 of them are mainly about Retinopathy of Prematurity (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-10.
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Who runs them
NICHD Neonatal Research Network (5) · Novartis Pharmaceuticals (4) · Duke University (4) · Aristotle University Of Thessaloniki (4) · Bayer (4) · Asociación para Evitar la Ceguera en México (3) · Children's Hospital of Philadelphia (3) · Jaeb Center for Health Research (3)
Who develops what
Save this setEvery programme with a company-led study here in the last two years, whatever its size: 1 programme from 1 company, 1 with this as their studies’ main aim; 0 with a live phase 3 study; 0 primary completions in the next 12 months.
Comparator & background therapies
What other companies’ phase 2+ studies give as the comparator or the background here (its leading trial sponsor and partners left out): a sign of what new drugs are measured against, not by itself the standard of care, its prescriptions or its market.
None given by two companies or more yet.
Programmes
“Meets, by arms” reads each study’s arms: vs its arm against the therapy’s; + X vs a combination against it; added to it plus the therapy against the therapy; studied with given together only. The next primary completion is the next phase-3 study’s when there is one.
The 1 programme — sign in to see the whole list, free: filter by phase and aim, sort by late development, direct comparisons or the next primary completion.
Primary completion in the next 12 months (0)
Live phase 2 and 3 studies of these programmes. Primary completion is when the main measure’s data collection ends, as the registry states it (most are estimates); results come later, if they are announced.
None in the next 12 months.
Read from ClinicalTrials.gov, industry-led studies. Main aim: this is the study’s judged main condition; named, not the main aim: the sponsor names it, the study is about something else; registry mapping only: only the registry’s mapping put it here. Leading trial sponsor is the company leading the most industry studies of a drug, a measure of trial activity, not of rights. US and EU rights, and Approved: from the regulators’ records (FDA’s Drugs@FDA via openFDA; EMA’s medicines data) — the holder of a marketed or authorised original, generics and other companies’ versions; not rights elsewhere, nor approval for this condition. Phase 4 trial recorded, where neither lists it: a phase 4 study exists somewhere. Not read yet: labels by indication, exclusivity, licences, line of therapy, academic comparators, sales.
What is being tested here
Drugs under test in Retinopathy of Prematurity studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Propranolol | 1 | 1 | 7 |
| Fentanyl | 1 | 0 | 1 |
| KH902 fusion protein | 1 | 0 | 1 |
| Dexmedetomidine | 1 | 1 | 1 |
| Faricimab | 1 | 1 | 1 |
| Bevacizumab | 0 | 2 | 7 |
| Ranibizumab | 0 | 3 | 6 |
| Aflibercept | 0 | 3 | 3 |
| Vitamin A | 0 | 0 | 3 |
| Mecasermin rinfabate | 0 | 0 | 2 |
Drug classes tested here Angiogenesis inhibitors 1 open
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
All 7
- Nov 2026Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next) · Regeneron Pharmaceuticals
- Dec 2026Safety, PK and PD of FLQ-101 in Premature Neonates · FELIQS INC.
- Dec 2026Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy · Wang Yusheng
- Feb 2027HBM-Based Education for Retinopathy of Prematurity Screening in Parents of Premature Infants · Aga Khan University
- Mar 2027An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK) · Bayer
- Mar 2027Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) · Duke University
- Aug 2027Imaging Retinal Vasculature in Infant Eyes · Duke University
Who these studies take
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 (100%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 4 (21%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 8 (42%) | 8 (42%) |
| 18 | 7 (37%) | 7 (37%) |
| 30 | 7 (37%) | 7 (37%) |
| 40 | 7 (37%) | 7 (37%) |
| 50 | 7 (37%) | 7 (37%) |
| 65 | 7 (37%) | 7 (37%) |
| 75 | 7 (37%) | 7 (37%) |
| 85 | 7 (37%) | 7 (37%) |
Across all 169 studies, recruiting or not: 76% stop at 75 or younger and 76% at 65; 98% take children; 0% are for women only and 0% for men only; 18% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
How long Retinopathy of Prematurity studies take
Of 30 interventional studies with no phase under Retinopathy of Prematurity, half reached primary completion within 14 months of starting, counting those still running.
| Start to primary completion | Every sponsor | Industry | Non-industry |
|---|---|---|---|
| Interventional, no phase | 14 mo11–31 · 30 studies | — | 14 mo12–31 · 28 studies |
| Observational | 31 mo16–53 · 25 studies | — | — |
Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out
What changed recently
From the registry's own updates since Oct 15, 2026.
Started recruiting1
- The Correlation Between Red Cell Transfusion and Complications of PrematurityOct 22, 2026NCT07123948
Studies
Recruiting first, then most recently updated. Showing 50 of 169. Browse all 169 → or search them.
- Retinopathy of Prematurity - Visual Function and Retinal StructureNot yet recruitingNCT074277191 country
- Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm InfantsNot yet recruitingNCT07502781Not applicable1 country
- An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)RecruitingNCT063155561 country
- The Correlation Between Red Cell Transfusion and Complications of PrematurityRecruitingNCT071239481 country
- Imaging Retinal Vasculature in Infant EyesRecruitingNCT055580591 country
- Safety, PK and PD of FLQ-101 in Premature NeonatesRecruitingNCT07093255Phase 11 country
- Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve CareRecruitingNCT07738874Not applicable1 country
- Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of PrematurityRecruitingNCT066125411 country
- Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity TherapyRecruitingNCT06717412Not applicable1 country
- Incidence of Hypoxia During Intravitreal Anti-VEGF (Vascular Endothelial Growth Factor) Injections for Retinopathy of Prematurity (ROP) Under Topical AnesthesiaRecruitingNCT077017591 country
- Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm InfantsNot yet recruitingNCT07112430Phase 1/21 country
- HBM-Based Education for Retinopathy of Prematurity Screening in Parents of Premature InfantsNot yet recruitingNCT07661654Not applicable
- Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)RecruitingNCT04995341Not applicable1 country
- Oral Propranolol for Prevention of Threshold Retinopathy of PrematurityRecruitingNCT03083431Phase 23 countries
- Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of PrematurityRecruitingNCT06067958Phase 31 country
- The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy ExaminationRecruitingNCT06694103Not applicable1 country
- Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter StudyRecruitingNCT06672913Not applicable1 country
- Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants with a BW >1500 Grs or GA ≥33 Wks in Turkey.RecruitingNCT062653631 country
- Long-term Ophthalmic Outcomes in Ex-premature InfantsNot yet recruitingNCT066495131 country
- Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural OutcomeRecruitingNCT00346814Phase 2/31 country
- Peripheral Avascular Retina in Retinopathy of PrematurityRecruitingNCT06044181Not applicable1 country
- Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity ExaminationNot yet recruitingNCT06348641Not applicable
- European Disease Registry on Retinopathy of Prematurity (ROP)RecruitingNCT0493957112 countries
- NeO2Matic-Pilot TrialNot yet recruitingNCT05629910Not applicable1 country
- The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic InflammationEnrolling by invitationNCT051442821 country
- Genetic Polymorphism and Retinopathy of Prematurity: Correlation of Clinical Presentations and SeverityRecruitingNCT051322571 country
- Clinical and Genetic Analysis of ROPRecruitingNCT044201561 country
- Prospective Evaluation of iCam-OCTCompletedNCT078399231 country
- A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROPTerminatedNCT04634604Phase 32 countries
- The Effect of Different Music Listened During Retinopathy Examination to Premature InfantsCompletedNCT05967572Not applicable1 country
- A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature InfantsActive, not recruitingNCT03253263Phase 213 countries
- A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in ChinaCompletedNCT067293331 country
- Intravitreal Ranibizumab for Aggressive Posterior Retinopathy of Prematurity: A Prospective Interventional Case SeriesCompletedNCT07721298Not applicable1 country
- A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)Active, not recruitingNCT057052581 country
- Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm InfantsCompletedNCT05387941Phase 11 country
- Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next)Active, not recruitingNCT0451552410 countries
- Bevacizumab Treatment For Type 1 ROPActive, not recruitingNCT04634578Phase 22 countries
- Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in New-born InfantsCompletedNCT02820662Not applicable1 country
- ROP Check Database Premature Infant OutcomesCompletedNCT073126691 country
- Automated Screening Device to Detect MTMROPCompletedNCT06517836Not applicable1 country
- Validation of i-ROP DL to Detect More Than Mild ROPActive, not recruitingNCT06109285Not applicable1 country
- Iron and Retinopathy of Prematurity (ROP)CompletedNCT051339991 country
- Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090CompletedNCT04015180Phase 324 countries
- The Effect of Breast Milk on Pain and StressCompletedNCT07127679Not applicable1 country
- Regulatory PMS Study for Lucentis® in Patients With Retinopathy of PrematurityCompletedNCT053049491 country
- Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity ScreeningCompletedNCT07016984Not applicable1 country
- A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in ChinaCompletedNCT055767921 country
- Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity ScreeningCompletedNCT05043077Phase 41 country
- umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)CompletedNCT05100212Phase 21 country
- To Assess the Effect of Dexamethasone Eye Drops on the Retinopathy of Prematurity OutcomeCompletedNCT067753531 country