Retinopathy of Prematurity (ROP)NCT01470430
VEGF In Systemic Circulation Of ROP-infants
An observational study of Retinopathy of Prematurity (ROP), run by University Hospital Freiburg at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: prematurely born infants with retinopathy of prematurity requiring treatment
Who may be able to join
- Clinical diagnosis of retinopathy of prematurity requiring treatment
Who cannot join
- Anemia
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Eye Hospital
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
Official title: Study to Measure Systemic VEGF Levels in ROP Infants Following Intravitreal Anti-VEGF Therapy or Retinal Laser Treatment
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.
- Conditions
- Retinopathy of Prematurity (ROP)
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ROP infants treated with intravitreal anti-VEGF agents | Not described | |
| ROP infants treated with retinal laser photocoagulation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (1)
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Stahl, MD, University Hospital Freiburg
- Investigators
- Andreas Stahl, MD, Principal investigator, University Eye Hospital Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470430
- Sponsor's protocol ID
- VISOR Study
- Status last verified
- Jan 2014
- First submitted
- 9 Nov 2011
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Measure Systemic VEGF Levels in ROP Infants Following Intravitreal Anti-VEGF Therapy or Retinal Laser Treatment
- ClinicalTrials.gov ID
- NCT01470430
- Acronym / sponsor ID
- VISOR Study
- Conditions
- Retinopathy of Prematurity (ROP)
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROP infants treated with intravitreal anti-VEGF agents | – | – |
| ROP infants treated with retinal laser photocoagulation | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- prematurely born infants with retinopathy of prematurity requiring treatment
Key inclusion criteria (1 listed)
- Clinical diagnosis of retinopathy of prematurity requiring treatment
Key exclusion criteria (1 listed)
- Anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Systemic levels of other growth factors (e.g. IGF-1)
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- University Eye Hospital Freiburg, GermanyLink provided by the sponsor.
Related trials for Retinopathy of Prematurity (ROP)
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Stahl, MD principal investigator
University Eye Hospital Freiburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity (ROP), run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic VEGF levels following treatment (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.