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Retinopathy of Prematurity

2
Pipeline Programs
13
Companies
14
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
0
1
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
3100%
+ 9 programs with unclassified modality

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
3 programs
1
RanibizumabPhase 3Monoclonal Antibody1 trial
LucentisN/A1 trial
RanibizumabN/AMonoclonal Antibody1 trial
Active Trials
NCT05304949Completed69Est. Jan 2025
NCT05576792Completed62Est. Jul 2024
NCT02375971Completed224Est. Dec 2017
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
Caffeine citratePhase 21 trial
Active Trials
NCT02344225Completed14Est. Jun 2018
Regeneron
RegeneronTARRYTOWN, NY
2 programs
Non-InterventionalN/A1 trial
afliberceptPHASE_31 trial
Active Trials
NCT04515524Active Not Recruiting100Est. Nov 2026
NCT04101721Completed127Est. Aug 2022
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
BevacizumabN/AMonoclonal Antibody4 trials
Active Trials
NCT00870636No Longer Available
NCT01182350Terminated53Est. Jun 2016
NCT00993044Completed13Est. Feb 2013
+1 more trials
Novartis
NovartisBASEL, Switzerland
1 program
LucentisN/A
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
Normal SalineN/A1 trial
Active Trials
NCT04883931CompletedEst. Jan 2022
Pediatrix Therapeutics
Pediatrix TherapeuticsChina - Shanghai
1 program
Registry for Severe ROP and Treatment on Visual OutcomesN/A1 trial
Active Trials
NCT01559571Completed324Est. May 2020
Abbott
AbbottABBOTT PARK, IL
1 program
carotenoidsN/A1 trial
Active Trials
NCT00872664Completed36Est. Jun 2013
Fresenius Kabi
Fresenius KabiGermany - Bad Homburg
1 program
cord blood-RBC concentratesPHASE_21 trial
Active Trials
NCT05100212Completed146Est. Jan 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Regeneronaflibercept
SandozRanibizumab
Fresenius Kabicord blood-RBC concentrates
Human BioSciencesCaffeine citrate
Angeles TherapeuticsBevacizumab
Angeles TherapeuticsBevacizumab
Angeles TherapeuticsBevacizumab
SandozRanibizumab
SandozLucentis
City TherapeuticsNormal Saline
RegeneronNon-Interventional
Pediatrix TherapeuticsRegistry for Severe ROP and Treatment on Visual Outcomes
Abbottcarotenoids

Clinical Trials (14)

Total enrollment: 1,244 patients across 14 trials

Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

Start: Oct 2019Est. completion: Aug 2022127 patients
Phase 3Completed

RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

Start: Dec 2015Est. completion: Dec 2017224 patients
Phase 3Completed
NCT05100212Fresenius Kabicord blood-RBC concentrates

umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)

Start: Dec 2021Est. completion: Jan 2025146 patients
Phase 2Completed

Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)

Start: Jan 2015Est. completion: Jun 201814 patients
Phase 2Completed

Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)

Start: Sep 2011Est. completion: Jun 201653 patients
Phase 2Terminated

Docetaxel With Bevacizumab as First-Line Therapy in Treating Women With Stage IV Breast Cancer

Start: May 2005Est. completion: Nov 201076 patients
Phase 2Completed

A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin

Start: Sep 2009Est. completion: Feb 201313 patients
Phase 1Completed

Use of Pan-vascular Endothelial Growth Factor Receptor (Pan-VEGF) Blockade for the Treatment of Retinopathy of Prematurity (ROP) (Compassionate Use BLOCK-ROP)

N/ANo Longer Available

A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China

Start: Jan 2023Est. completion: Jul 202462 patients
N/ACompleted

Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity

Start: Jun 2022Est. completion: Jan 202569 patients
N/ACompleted

Mother Milk as a Eye Drop & Premature Retinopathy

Start: May 2021Est. completion: Jan 2022
N/ACompleted
NCT04515524RegeneronNon-Interventional

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)

Start: Feb 2021Est. completion: Nov 2026100 patients
N/AActive Not Recruiting
NCT01559571Pediatrix TherapeuticsRegistry for Severe ROP and Treatment on Visual Outcomes

Registry for Severe ROP and Treatment on Visual Outcomes

Start: May 2012Est. completion: May 2020324 patients
N/ACompleted

Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids

Start: Sep 2009Est. completion: Jun 201336 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
13 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.