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Home › Conditions › retinopathy of prematurity

Retinopathy of prematurity

6 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for retinopathy of prematurity

9 trials tracked for retinopathy of prematurity: 3 in phase 3 or 4 and 1 with published results. The most-cited published study has 438 citations.

9Trials tracked
3Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 3 3 Phase 2 4 Phase 1 1 Other / NA 1
  1. Phase 3 RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity Completed · 438 cited
  2. Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity Completed
  3. Phase 3 Surfactant Positive Airway Pressure and Pulse Oximetry Trial Completed
  4. Phase 2 Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study) Completed
  5. Phase 2 Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity Completed
  6. Phase 2 Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study Completed
Show 3 more trials
  1. Phase 2 Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2) Completed
  2. Phase 1 Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity Completed
  3. N/A The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities Completed

Showing the 9 most-cited and recently-updated of 9 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Retinopathy of prematurity: what the trials found

Ranibizumab has been evaluated for the treatment of retinopathy of prematurity (ROP). In a Phase 3 trial, patients treated with Ranibizumab showed an 80.0% success rate in achieving both the absence of active ROP and the absence of unfavorable structural outcomes in both eyes at week 24 (p=0.0254) 1. Conversely, the percentage of participants requiring a second modality for ROP at week 24 was significantly lower in the Ranibizumab group compared to other comparison groups (14.9% vs. 16.9% and 24.3%) 1.

Aflibercept is established as an intervention for ROP. In a Phase 3 trial, 77.8% of participants treated with aflibercept showed an absence of active ROP and unfavorable structural outcomes from baseline to week 52 of chronological age 2. Additionally, the rate of patients requiring a second treatment modality was 18.5% for aflibercept compared to 15.1% in the comparison group 2.

Surfactant has been investigated in Phase 3 trials for this condition 3.

Recent results — preliminary, needs further review

  • Omegaven showed significant changes in mRNA expression of STC-1 at T2 (p=0.001), though results for STAT3 and PPAR-gamma were not statistically significant 4.
  • Inositol lower volume was evaluated regarding composite motor and cognitive scores, but data is not yet corroborated 5.
  • Caffeine citrate was studied for efficacy in reducing the number of participants presenting with ROP and the rate of stages/grade 6.
  • Propranolol was investigated in a Phase 2 trial 7.
  • Bevacizumab was evaluated regarding visual fixation status at 12 months 8.

For the clinician treating this condition

  • Ranibizumab demonstrated a statistically significant reduction in the need for secondary interventions and improved outcomes regarding active ROP and structural integrity at 24 weeks 1.
  • Aflibercept showed high rates of successful outcomes (absence of active ROP and unfavorable structural outcomes) through week 52 2.
  • Surfactant is an established intervention in the management context of this condition 3.

AI synthesis of 8 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Erythropoietin Dynamics and Neuroimaging Outcomes in Extremely Preterm Infants with Retinopathy
Pediatrics RCT
Erythropoietin Dynamics and Neuroimaging Outcomes in Extremely Preterm Infants with Retinopathy Erythropoietin Levels Linked to Brain Injury in Preterm Infants
This post-hoc analysis explores how erythropoietin levels correlate with MRI findings of brain injury and retinopathy in extremely preterm i…
New data explores how erythropoietin levels and blood transfusions impact brain health and eye risks in extremely preterm infants.
Jun 26, 2026
DHA and ARA supplementation significantly reduces risk of severe retinopathy of prematurity in preterm infants
Ophthalmology Meta-analysis
DHA and ARA supplementation significantly reduces risk of severe retinopathy of prematurity in preterm infants DHA and ARA Supplementation May Reduce Severe Retinopathy Risk
This meta-analysis of randomized trials evaluates enteral DHA and ARA supplementation for retinopathy of prematurity (ROP) in preterm infant…
Supplementing preterm infants with DHA and ARA may lower the risk of severe, sight-threatening eye conditions like retinopathy of prematurit…
medRxiv Jun 17, 2026
Meta-analysis of ROP treatments finds anti-VEGF linked to less myopia than laser or surgery
Rheumatology Meta-analysis
Meta-analysis of ROP treatments finds anti-VEGF linked to less myopia than laser or surgery Anti-VEGF Treatment Leads To Better Vision Outcomes For Premature Babies
This systematic review and meta-analysis of 10,269 eyes found anti-VEGF treatment for retinopathy of prematurity was associated with the lea…
New research shows that anti-VEGF injections lead to better long-term vision for premature babies than laser or freezing methods.
Frontiers May 15, 2026
Narrative review identifies emerging associations between gut microbiota and pediatric eye conditions
Ophthalmology Sys. Review
Narrative review identifies emerging associations between gut microbiota and pediatric eye conditions Early gut bugs may shape your child's eye health for life
This narrative review examines associations between gut microbiota dysbiosis and pediatric ophthalmic conditions including myopia and allerg…
New research suggests that the tiny bugs living in a child's gut could be the hidden reason behind their eye problems.
Frontiers Apr 28, 2026
Cochrane review finds very low-certainty evidence on IGF-1 for ROP in preterm infants
Diabetes & Endocrinology Sys. Review
Cochrane review finds very low-certainty evidence on IGF-1 for ROP in preterm infants Premature Babies and Eye Disease: A Hopeful Treatment Hits a Wall
This Cochrane systematic review synthesized evidence from two RCTs on IGF-1 for retinopathy of prematurity in preterm infants.
A promising hormone-based treatment for a leading cause of infant blindness has been tested in clinical trials, but the evidence is too thin…
Cochrane Apr 18, 2026
ROP incidence declined over 10 years in Chinese preterm infants, with no Type 1 cases in larger infants after 2018
Pediatrics Cohort
ROP incidence declined over 10 years in Chinese preterm infants, with no Type 1 cases in larger infants after 2018 Why a Common Cause of Premature-Baby Blindness Is Steadily Disappearing
A single-center retrospective study of 603 premature infants undergoing ROP screening in Sichuan, China, found overall ROP incidence decline…
A serious eye disease causing blindness in premature babies is becoming much rarer, with recent data showing severe cases disappearing in in…
Frontiers Apr 13, 2026

Questions about retinopathy of prematurity

Does anti-VEGF treatment cause less nearsightedness compared to laser surgery for retinopathy of prematurity?

Anti-VEGF treatment results in less nearsightedness than laser surgery for retinopathy of prematurity, with lower rates of high myopia and astigmatism.

Full answer →