Clinical trials: Retinopathy of Prematurity
Retinopathy of Prematurity
The Effects of Light Reduction on Retinopathy of Prematurity (Light-ROP)
To evaluate the effect of ambient light reduction on the incidence of retinopathy of prematurity (ROP).
- Trial name
- NCT00000156
- Testing
- Goggles, Ambient Light Reduction
- Where
- 3 sites in United States
- Sponsor
- National Eye Institute (NEI)
Neonatal Pain, Retinopathy of Prematurity (ROP)
Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants
The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm…
- Conditions
- Neonatal Pain, Retinopathy of Prematurity (ROP), Pain Management, Infant, Premature
- Trial name
- FIREFLY (NCT07112430)
- Testing
- Fentanyl Citrate (Intranasal)
- Where
- Canada
- Volunteers
- 58 people
- Sponsor
- Marsha Campbell-Yeo
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Retinopathy of Prematurity
Bevacizumab Treatment For Type 1 ROP
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases.
- Trial name
- ROP4 (NCT04634578)
- Testing
- Bevacizumab
- Where
- 26 sites in United States, Canada
- Volunteers
- 77 people
- Sponsor
- Jaeb Center for Health Research
Retinopathy of Prematurity, Myopia
Prematurity and Ophthalmological Changes
Ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity
- Trial name
- NCT06452524
- Testing
- axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)
- Where
- Turkey (Türkiye)
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Ankara City Hospital Bilkent
Prematurity, Eye Fundus
Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital
As part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus.
- Trial name
- Voix Chantée (NCT03830580)
- Testing
- Positive stimulation (singing)
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Retinopathy of Prematurity
Long Term Outcome of Intravitreal Ranibizumab for ROP
premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year were examined for refractive state and biometry
- Trial name
- NCT04537065
- Testing
- cycloplegic refraction
- Where
- Egypt
- Volunteers
- 140 people
- Sponsor
- Ameera Gamal Abdelhameed
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Bronchopulmonary Dysplasia; Retinopathy of Prematurity
Integrated Proteomic HPLC-ESI-MS Analysis of Salivary Peptides of Preterm Newborns: a Pilot Study
The analysis of saliva of preterm newborns could be a powerful tool to investigate human fetal development in an ethically acceptable fashion, indeed the collection of salivary samples is a fast and non-invasive procedure.
- Trial name
- NCT05782101
- Testing
- Integrated proteomic HPLC-ESI-MS analysis of salivary peptides
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Retinopathy of Prematurity, Diabetic Retinopathy
Optical Coherence Tomography Angiography (OCT-A) in Children (≥ 6 <14 Years of Age)
Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases in children
- Trial name
- OCTAC (NCT03399825)
- Testing
- OCT-A
- Volunteers
- healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Retinopathy of Prematurity
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP).
- Trial name
- BUTTERFLEYE (NCT04101721)
- Testing
- aflibercept, laser photocoagulation
- Where
- 52 sites in United States, Bulgaria and 11 more
- Volunteers
- 127 people
- Sponsor
- Regeneron Pharmaceuticals
Retinopathy of Prematurity
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (ROP), is effective in this study, and can be tested in future larger studies.
- Trial name
- ROP1 (NCT02390531)
- Testing
- Bevacizumab
- Where
- 11 sites in United States
- Volunteers
- 120 people
- Sponsor
- Jaeb Center for Health Research
Retinopathy of Prematurity, Retinal Detachment
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be…
- Conditions
- Retinopathy of Prematurity, Retinal Detachment, Blindness
- Trial name
- ROP (NCT00634972)
- Testing
- ACULAR, REFRESH TEARS
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- University of South Alabama
Retinopathy of Prematurity
Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
This study is a retrospective, multi-center real world study. The real world data comes from the electronic medical record system and disease database of the research centers .The patient's demographic information, disease…
- Trial name
- NCT04985448
- Where
- 2 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Chengdu Kanghong Biotech Co., Ltd.
Retinopathy of Prematurity (ROP), Premature Birth
Long-term Ophthalmic Outcomes in Ex-premature Infants
There is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely. This study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood.
- Trial name
- LTOO-XP (NCT06649513)
- Testing
- eye drops (Tropicamid)
- Where
- Netherlands
- Volunteers
- 210 people
- Sponsor
- Erasmus Medical Center
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants…
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
- Trial name
- NCT03253263
- Testing
- OHB-607
- Where
- 62 sites in United States, Australia and 11 more
- Volunteers
- 295 people
- Sponsor
- OHB Neonatology Ltd.
Retinopathy of Prematurity (ROP)
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe…
- Trial name
- FIREFLEYE (NCT04004208)
- Testing
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Where
- 90 sites in Argentina, Austria and 25 more
- Volunteers
- 113 people
- Sponsor
- Bayer
Retinopathy of Prematurity, Pain Management
Pain Management During Screening for Retinopathy of Prematurity
Abstract Background: Screening examinations for retinopathy of prematurity (ROP) is critical to reduce ROP-related vision loss, however, the procedure is painful and uncomfortable, and topical anesthetics do not completely…
- Trial name
- NCT04767178
- Testing
- Ibuprofen (Sanofi, Istanbul, Turkey), Paracetamol (GlaxoSmithKline, Istanbul, Turkey)
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people
- Sponsor
- Istanbul Medeniyet University
Retinopathy of Prematurity
Refractive Error and Biometry in Retinopathy of Prematurity
The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents.
- Trial name
- NCT03334513
- Testing
- Bevacizumab, Ranibizumab
- Volunteers
- 35 people
- Sponsor
- San Ni Chen
Pain During ROP Exam
ROP Screening: Comparison of Pain Using Two Eyelid Retractors
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally.
- Trial name
- NCT02152046
- Testing
- ROP exam with spring loaded retractor, ROP exam with screw retractor
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Wake Forest University Health Sciences