NCT03115255

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

October 12, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

March 27, 2017

Last Update Submit

October 10, 2018

Conditions

Infant, Premature, Diseases

Keywords

retinopathy of prematurityranibizumabvascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

  • The effect of intravitreal ranibizumab on serum VEGF level

    the changes of the serum VEGF levels

    1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab

Secondary Outcomes (3)

  • The effect of intravitreal ranibizumab on weight

    corrected age of six month

  • The effect of intravitreal ranibizumab on height

    corrected age of six month

  • The effect of intravitreal ranibizumab on neurologic development

    corrected age of six month

Study Arms (1)

serum VEGF level

EXPERIMENTAL

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

Drug: intravitreal ranibizumab

Interventions

intravitreal ranibizumabDRUG

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

Also known as: lucentis
serum VEGF level

Eligibility Criteria

Age4 Weeks - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with vascularly active ROP
  • intravitreal ranibizumab

You may not qualify if:

  • already accepted laser therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Infant, Premature, DiseasesRetinopathy of Prematurity

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hongping Xia, MD. PhD

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2017

First Posted

April 14, 2017

Study Start

May 1, 2017

Primary Completion

May 31, 2018

Study Completion

June 30, 2018

Last Updated

October 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)