Ranibizumab for Retinopathy of Prematurity
This study is evaluating whether intravitreal ranibizumab is more effective than laser ablation therapy in treating ROP.
See full descriptionAbout the trial for Retinopathy of Prematurity
Treatment Groups
This trial involves 2 different treatments. Ranibizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
About The Treatment
Eligibility
This trial is for patients born any sex of any age. There are 2 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Ranibizumab will improve 15 secondary outcomes in patients with Retinopathy of Prematurity. Measurement will happen over the course of at the patient's fifth birthday.
Patient Q & A Section
What is retinopathy of prematurity?
Retinopathy of prematurity is an ocular disorder in the retina of premature babies. It does not always lead to blindness, but if it does, its most severe form is called chronic progressive retinal detachment. This usually results in blindness.\n
What causes retinopathy of prematurity?
The exact cause of retinopathy of prematurity is unknown. It is suggested that some infections, maternal hypertension, and premature birth are associated with increased risk of retinopathy of prematurity. It is not obvious why premature babies and those who spend more time in neonatal intensive care units (NICUs) are more prone to develop retinopathy of prematurity; so there is not enough evidence to show if these factors are really risk factors for retinopathy of prematurity.
What are common treatments for retinopathy of prematurity?
The majority of children treated with a silicone oil (Turboglobe) catheter (or some other silicone oil) experienced vitreous haze when compared with controls. The presence of haze is most often temporary and can resolve with repeat insertion and aspiration. Surgical intervention was needed in about 10% of the cases. Vitopatch IOP devices can be used to prevent corneal oedema in premature infants. They work by creating a continuous positive pressure within the anterior chamber. If this fails to relieve the baby's symptoms, the IOP device may be surgically removed. Most physicians prefer the silicone oil devices, since they do not require removal. The use of hyperoxic gas (high concentration oxygen) is controversial.
How many people get retinopathy of prematurity a year in the United States?
A total of 13.6 million-33 years old children were diagnosed with ROP in 2007 with a total of 605 infants receiving laser treatment for ROP, which is less than the previous estimate of 1423 infants in 2004. The incidence of ROP in premature infants is decreasing. New Jersey, Indiana, Arizona, Oregon, and New Hampshire lead the country in number of newborns diagnosed with ROP in each state while all states ranked in the top ten had a decrease in incidence in some timeframe. Most states did not meet the current national incidence goal of 50% in the time frame.
Can retinopathy of prematurity be cured?
This report shows that ROP can be repaired in more than 50% of all cases if treatment is started within 5 days of the appearance of active disease and that laser photocoagulation can be used to reduce the risk of developing retinal detachment by a factor of up to 5.
What are the signs of retinopathy of prematurity?
Screening premature infants for ROP appears essential. The risk of ROP-associated glaucoma depends on the stage of disease and the amount of blood flow to the retina. The clinical diagnosis as well as the management of ROP have improved, but the disease remains a major health hazard and a cause of morbidity and premature death. More research and understanding is needed; in particular the determination of the risk factors for ROP and the optimization of perinatal care are essential.
Is ranibizumab safe for people?
Ranibizumab infusion safety and tolerability was comparable to bevacizumab and was similar to previously reported data for a 2-year course of bevacizumab in this patient population. Ranibizumab can be administered safely at doses of 0.5 or 1.0 mg in infants weighing < or = 28 kg.
What is the average age someone gets retinopathy of prematurity?
In this cohort, the greatest percentage of severe ROP was seen in the patients older than 35 days. The rate of this disease was also similar in children younger than 35 days with ROP compared with those older than this age. In general, all eyes were surgically treated in the younger patients. Those older than 35 days had an average of more advanced disease and the use of anti-vascular endothelial growth factor treatment. The incidence and progression of severe ROP in these patients were higher. The incidence of severe ROP was 4.4% in the babies older than 35 days, 3.7% in the younger age group, and 0.2% in the 25-day-old babies.
How does ranibizumab work?
Ranibizumab therapy was effective in reducing the number of ROP-affected eye and decreasing or averting the requirement to laser. It was also effective in maintaining this reduction of ROP in the long term.
What is the primary cause of retinopathy of prematurity?
The main cause of ROP is not just the low oxygen content in the fetal environment, but also other factors that the neonate cannot control. More advanced techniques are required, such as the use of the HABITAT platform which can accurately predict the severity of NPDR and its subsequent progression.
Who should consider clinical trials for retinopathy of prematurity?
Retinopathy of prematurity affects almost 1 in 100 preterm newborns. Due to its significant morbidity and mortality, it is essential to invest in research to develop therapies and treatments, in order to reduce the damage to sight and visual function in infants with retinopathy of prematurity. Clinical trials for treatment, therapies and treatment outcomes should be considered in high-risk infants with ROP and low-risk infants without ROP, as well as in the preterm infants after birth to decrease the risk as ROP.
What are the latest developments in ranibizumab for therapeutic use?
Ranibizumab treatment has proven to be efficacious and effective for preventing retinal vaso-occlusion in very low birth weight infants and improving vision acquisition. Further studies are needed to determine if ranibizumab may affect long term visual development in these children. The new available agent has allowed us to improve patient management.