Retinopathy of Prematurity (ROP) Clinical Trial
Official title:
Study to Measure Systemic VEGF Levels in ROP Infants Following Intravitreal Anti-VEGF Therapy or Retinal Laser Treatment
NCT number | NCT01470430 |
Other study ID # | VISOR Study |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | November 9, 2011 |
Last updated | January 26, 2014 |
Start date | March 2012 |
Verified date | January 2014 |
Source | University Hospital Freiburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of retinopathy of prematurity requiring treatment Exclusion Criteria: - Anemia |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | University Eye Hospital | Freiburg | Baden-Wuerttemberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Freiburg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Systemic levels of other growth factors (e.g. IGF-1) | comparing systemic levels of other (non-VEGF) factors in serum of ROP infants treated with intravitreal anti-VEGF agents vs. retinal laser photocoagulation | 16 weeks | No |
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