Retinopathy of Prematurity Clinical Trial
Official title:
Department of Neonatology, Children's Hospital of Zhengzhou
Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in
children in both developing and developed countries around the world. ROP is a
multifactorial disease characterized by perturbation of normal vascular development in the
retina. The pathogenesis of ROP is hypothesized to consist of two distinct phases of which
the second phase is characterized by hypoxia-induced up-regulation of vascular endothelial
growth factor (VEGF) and retinal neovascularization.
Recent studies have shown a relationship between the β-adrenergic system and angiogenesis.
This relationship has been observed in several diseases, like infantile hemangiomas, ROP,
and neoplasias. Studies in animal models have shown that norepinephrine stimulates VEGF
expression and secretion in retinal cells. In oxygen induced retinopathy, blockage of
β-adrenergic receptors (β-AR) can inhibit the angiogenic cascade and interfere with further
proliferation of retinal vasculature. Also, angiogenesis seems to be impaired in β-Argene
deficient mice, when exposed to hypoxia and other stimuli, but this function is restored
after gene therapy.
Assuming in human preterm newborns with ROP that VEGF overexpression and retinal
neovascularization in response to hypoxia might involve b-AR activation, we design
prospective randomized study to assess the effect of oral propranolol on the progression of
early stages of ROP in very low birth weight infants.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 24 Weeks to 45 Weeks |
Eligibility |
Inclusion Criteria: - preterm newborns with GA <32 weeks of age and Stage 2 ROP without plus in zone II Exclusion Criteria: - newborns with congenital or acquired cardiovascular anomalies, renal failure or cerebral hemorrhage at enrollment, and newborns with ROP in zone I or at a more advanced stage than Stage 2 without plus in zone II. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Propranolol | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Huiqing Sun |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rates of regression of Retinopathy of Prematurity | 2 years | Yes |
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