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VEGF In Systemic Circulation Of ROP-infants

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470430
First Posted: November 11, 2011
Last Update Posted: January 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andreas Stahl, MD, University Hospital Freiburg
  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 Andreas Stahl, MD, University Hospital Freiburg:

Primary Outcome Measures:
  • Systemic VEGF levels following treatment [ Time Frame: 16 weeks ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Andreas Stahl, MD, MD, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01470430     History of Changes
Other Study ID Numbers: VISOR Study
First Submitted: November 9, 2011
First Posted: November 11, 2011
Last Update Posted: January 28, 2014
Last Verified: January 2014

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