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| Status | Withdrawn |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| Status | Withdrawn |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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04506619 -
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
|
||
| Completed |
NCT04004208 -
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
|
Phase 3 | |
| Recruiting |
NCT03253263 -
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
|
Phase 2 | |
| Completed |
NCT02386839 -
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
|
Phase 2 | |
| Completed |
NCT01054027 -
Study on Effective Mydriasis in Premature Infants
|
N/A | |
| Active, not recruiting |
NCT04015180 -
Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
|
Phase 3 | |
| Completed |
NCT01096784 -
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
|
Phase 2 | |
| Completed |
NCT02640664 -
Rainbow Extension Study
|
Phase 3 | |
| Completed |
NCT02134457 -
Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity
|
Phase 2 | |
| Terminated |
NCT01954082 -
Inositol to Reduce Retinopathy of Prematurity
|
Phase 3 |