VEGF In Systemic Circulation Of ROP-infants

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Andreas Stahl, MD, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT01470430
First received: November 9, 2011
Last updated: January 26, 2014
Last verified: January 2014
  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:


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


Enrollment: 0
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470430

Locations
Germany
University Eye Hospital
Freiburg, Baden-Wuerttemberg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Andreas Stahl, MD University Eye Hospital Freiburg, Germany
  More Information

Additional Information:
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: January 26, 2014
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 August 26, 2014