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VEGF In Systemic Circulation Of ROP-infants

This study is not yet open for participant recruitment.
Verified December 2011 by University Hospital Freiburg
Sponsor:
Information provided by (Responsible Party):
Andreas Stahl, MD, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT01470430
First received: November 9, 2011
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition
Retinopathy of Prematurity (ROP)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study to Measure Systemic VEGF Levels in ROP Infants Following Intravitreal Anti-VEGF Therapy or Retinal Laser Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Systemic VEGF levels following treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    comparing VEGF levels in serum of ROP infants treated with intravitreal anti-VEGF agents vs. retinal laser photocoagulation over 16 weeks post treatment


Secondary Outcome Measures:
  • Systemic levels of other growth factors (e.g. IGF-1) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    comparing systemic levels of other (non-VEGF) factors in serum of ROP infants treated with intravitreal anti-VEGF agents vs. retinal laser photocoagulation


Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ROP infants treated with intravitreal anti-VEGF agents
ROP infants treated with retinal laser photocoagulation

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

prematurely born infants with retinopathy of prematurity requiring treatment

Criteria

Inclusion Criteria:

  • Clinical diagnosis of retinopathy of prematurity requiring treatment

Exclusion Criteria:

  • Anemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470430

Contacts
Contact: Andreas Stahl, MD 004976127040010 andreas.stahl@uniklinik-freiburg.de
Contact: Wolf A Lagreze, MD 004976127040110 wolf.lagreze@uniklinik-freiburg.de

Locations
Germany
University Eye Hospital Not yet recruiting
Freiburg, Baden-Wuerttemberg, Germany, 79106
Contact: Andreas Stahl, MD     004976127040010     andreas.stahl@uniklinik-freiburg.de    
Contact: Wolf A Lagreze, MD     004976127040110     wolf.lagreze@uniklinik-freiburg.de    
Principal Investigator: Andreas Stahl, MD            
Principal Investigator: Wolf A Lagreze, MD            
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Andreas Stahl, MD University Eye Hospital Freiburg, Germany
  More Information

Additional Information:
University Eye Hospital Freiburg, Germany  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Andreas Stahl, MD, MD, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01470430     History of Changes
Other Study ID Numbers: VISOR Study
Study First Received: November 9, 2011
Last Updated: December 13, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 23, 2013