NCT01470430

Brief Summary

The purpose of this study is to measure systemic levels of vascular endothelial growth factor (VEGF) and other proteins (e.g. IGF-1) in the systemic circulation of infants with retinopathy of prematurity (ROP) following ocular treatment with either intravitreal injections of anti-VEGF agents or retinal laser photocoagulation. The primary aim is to determine if serum VEGF levels change after treatment.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

November 9, 2011

Last Update Submit

January 26, 2014

Conditions

Retinopathy of Prematurity (ROP)

Outcome Measures

Primary Outcomes (1)

  • Systemic VEGF levels following treatment

    comparing VEGF levels in serum of ROP infants treated with intravitreal anti-VEGF agents vs. retinal laser photocoagulation over 16 weeks post treatment

    16 weeks

Secondary Outcomes (1)

  • Systemic levels of other growth factors (e.g. IGF-1)

    16 weeks

Study Arms (2)

ROP infants treated with intravitreal anti-VEGF agents

ROP infants treated with retinal laser photocoagulation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

prematurely born infants with retinopathy of prematurity requiring treatment

You may qualify if:

  • Clinical diagnosis of retinopathy of prematurity requiring treatment

You may not qualify if:

  • Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Links

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Andreas Stahl, MD

    University Eye Hospital Freiburg, Germany

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

DE(1)