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Retinopathy of Prematurity clinical trials

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NCT ID: NCT02655432 Withdrawn - Cataract Clinical Trials

Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population

POPH
Start date: January 2016
Phase: Phase 0
Study type: Observational

Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk factors with the use of the Spot photoscreener. The photoscreener results will be compared to the complete ophthalmologic evaluation. Primarily, this will allow evaluation of the performance of the spot photoscreener in the haitian children population. Secondarily, this study will gather epidemiological information on vision problems in the haitian children population.

NCT ID: NCT02640664 Completed - Clinical trials for Retinopathy of Prematurity (ROP)

Rainbow Extension Study

RainbowExt
Start date: June 16, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)

NCT ID: NCT02504944 Completed - Clinical trials for Retinopathy of Prematurity

Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye drops in treating preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no more than 90 days. Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.

NCT ID: NCT02486042 Completed - Clinical trials for Retinopathy of Prematurity

Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity

Start date: March 2014
Phase: Phase 2
Study type: Interventional

Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely. These infants do not have enough essential fatty acids to structurally support the retina, the nerve tissue in the eye which allows us to see. A recent study showed that giving omega-3 (n-3) fatty acids to these infants soon after birth made them less likely to need invasive treatments for eye disease. This research trial will give young infants born prematurely n-3 fish oil treatment and look at how this changes factors in the blood that promote disease. Detailed blood studies comparing infants with and without ROP will be performed and the infants will be followed over time to assess their eye development.

NCT ID: NCT02484989 Completed - Clinical trials for Retinopathy of Prematurity

UK Surveillance of Treated Retinopathy of Prematurity

Start date: May 2013
Phase: N/A
Study type: Observational [Patient Registry]

Currently, there is little recent data on regional variations in treatment methods, neonatal units that provide retinopathy (ROP) treatment, facilities for treatment available at each unit including anaesthetic support for such preterm babies, facilities to transfer babies to units that offer treatment etc. While some parts of the UK have established neonatal networks and agreements among units for ROP treatment, in other parts, such arrangements are illdefined. The number of babies needing ROP treatment may be higher since the introduction of revised guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the incidence of treatable ROP, the treatment methods used and facilities for treatment will provide the foundation for effective planning of resources and manpower to deal with the additional demand.

NCT ID: NCT02390531 Completed - Clinical trials for Retinopathy of Prematurity

Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

ROP1
Start date: April 28, 2015
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT02386839 Completed - Clinical trials for 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)

PEDAL
Start date: March 26, 2015
Phase: Phase 2
Study type: Interventional

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).

NCT ID: NCT02375971 Completed - Clinical trials for Retinopathy of Prematurity

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

RAINBOW
Start date: December 30, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

NCT ID: NCT02344225 Completed - Clinical trials for Retinopathy of Prematurity

Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)

SPIPROP
Start date: January 1, 2015
Phase: Phase 2
Study type: Interventional

Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study is designed to determine whether the novel treatment regimens are safe and potentially effective for ROP prevention and to obtain requisite data for the development of a Phase III efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as standard of care for ELGANs, no placebo group is included.

NCT ID: NCT02257307 Terminated - Clinical trials for Retinopathy of Prematurity

Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

Start date: July 2014
Phase: N/A
Study type: Observational

Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a multi-center observational study will focus on feasibility, and relative cost-effectiveness of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical Center.