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Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03115255
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab

Condition or disease Intervention/treatment Phase
Infant, Premature, Diseases Drug: intravitreal ranibizumab Not Applicable

Detailed Description:
Infants with ROP are studied. They received 0.25 mg or 0.5 mg of intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases) with vascularly active ROP. Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab. The serum concentrations of ranibizumab and VEGF are measured by enzyme-linked immunosorbent assay, and the changes of the serum VEGF levels are determined.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: serum VEGF level
Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab
Drug: intravitreal ranibizumab
0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)
Other Name: lucentis




Primary Outcome Measures :
  1. The effect of intravitreal ranibizumab on serum VEGF level [ Time Frame: 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab ]
    the changes of the serum VEGF levels


Secondary Outcome Measures :
  1. The effect of intravitreal ranibizumab on weight [ Time Frame: corrected age of six month ]
    measure weight of the infants

  2. The effect of intravitreal ranibizumab on height [ Time Frame: corrected age of six month ]
    measure height of the infants

  3. The effect of intravitreal ranibizumab on neurologic development [ Time Frame: corrected age of six month ]
    Gesell development diagnosis scale



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants with vascularly active ROP
  • intravitreal ranibizumab

Exclusion Criteria:

  • already accepted laser therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115255


Locations
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China, Shanghai
Xinhua Hospital
Shanghai, Shanghai, China, 200092
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Hongping Xia, MD. PhD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03115255     History of Changes
Other Study ID Numbers: XH-17-004
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
retinopathy of prematurity
ranibizumab
vascular endothelial growth factor

Additional relevant MeSH terms:
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Retinopathy of Prematurity
Infant, Premature, Diseases
Retinal Diseases
Eye Diseases
Infant, Newborn, Diseases
Ranibizumab
Endothelial Growth Factors
Mitogens
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action