Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab

NCT ID: NCT03115255

Last Updated: 2018-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Infant, Premature, Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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serum VEGF level

Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab

Group Type EXPERIMENTAL

intravitreal ranibizumab

Intervention Type DRUG

0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)

Interventions

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intravitreal ranibizumab

0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)

Intervention Type DRUG

Other Intervention Names

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lucentis

Eligibility Criteria

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Inclusion Criteria

* Infants with vascularly active ROP
* intravitreal ranibizumab

Exclusion Criteria

* already accepted laser therapy
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongping Xia, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Xinhua Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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XH-17-004

Identifier Type: -

Identifier Source: org_study_id

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