Choroidal NeovascularizationNCT01298440
Bevacizumab Effect on Blood Velocity
An observational study of Choroidal Neovascularization, run by Optical Imaging, Ltd. at 1 site in Israel.
Trial summary
Retinal blood flow velocity is affected by Bevacizump intravitreal injection. This effect is correlated to treatment success. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Choroidal Neovascularization
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Jun 2008
- 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: Patients with choroidal neovascularization (CNV)
Who may be able to join
- Patients with CNV receiving Bevacizumab intravitreal injection
Who cannot join
- Candidates in whom the retina could not be seen clearly because of media opacity or a poorly dilating pupil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intravitreal Bevacizumab (Avastin) Injection on Retinal Blood-Flow Velocity in Patients With Choroidal Neovascularization
Retinal blood flow velocity is affected by Bevacizump intravitreal injection. This effect is correlated to treatment success.
Read the detailed description
The purpose of the study was to carry out a pilot study on the short-term effect of intravitreal Bevacizumab (Avastin) injection on retinal blood-flow velocity and test whether the short-term haemodynamic changes could predict the longer term clinical result of the treatment.
- Conditions
- Choroidal Neovascularization
- Medical subject headings
- Choroidal Neovascularization
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow velocity change
Measured: 1 day following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Choroidal NeovascularizationStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optical Imaging, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Adiel Barak, MD, Principal investigator, Tel aviv university Sackler school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298440
- Sponsor's protocol ID
- AvastinRFI
- Status last verified
- Feb 2011
- First submitted
- 16 Feb 2011
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burgansky-Eliash Z, Lowenstein A, Neuderfer M, Kesler A, Barash H, Nelson DA, Grinvald A, Barak A. The correlation between retinal blood flow velocity measured by the retinal function imager and various physiological parameters. Ophthalmic Surg Lasers Imaging Retina. 2013 Jan-Feb;44(1):51-8. doi: 10.3928/23258160-20121221-13.
PubMed 23418734
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravitreal Bevacizumab (Avastin) Injection on Retinal Blood-Flow Velocity in Patients With Choroidal Neovascularization
- ClinicalTrials.gov ID
- NCT01298440
- Acronym / sponsor ID
- AvastinRFI
- Conditions
- Choroidal Neovascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Optical Imaging, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Feb 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.
Retinal blood flow velocity is affected by Bevacizump intravitreal injection. This effect is correlated to treatment success.
Detailed description
The purpose of the study was to carry out a pilot study on the short-term effect of intravitreal Bevacizumab (Avastin) injection on retinal blood-flow velocity and test whether the short-term haemodynamic changes could predict the longer term clinical result of the treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with choroidal neovascularization (CNV)
Key inclusion criteria (1 listed)
- Patients with CNV receiving Bevacizumab intravitreal injection
Key exclusion criteria (1 listed)
- Candidates in whom the retina could not be seen clearly because of media opacity or a poorly dilating pupil
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
Blood flow velocity change
Time frame: 1 day following injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
- Derived from this study: PubMed 23418734Burgansky-Eliash Z, Lowenstein A, Neuderfer M, Kesler A, Barash H, Nelson DA, Grinvald A, Barak A. The correlation between retinal blood flow velocity measured by the retinal function imager and various physiological parameters. Ophthalmic Surg Lasers Imaging Retina. 2013 Jan-Feb;44(1):51-8. doi: 10.3928/23258160-20121221-13.
Related trials for Choroidal Neovascularization
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
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.
Adiel Barak, MD principal investigator
Tel aviv university Sackler school of medicine
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 Choroidal Neovascularization, run by Optical Imaging, Ltd. at 1 site in Israel.
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: finished, as of the sponsor's last update on 17 Feb 2011. 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood flow velocity change (time frame: 1 day following injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01298440, which also lists 1 linked publication.
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 17 Feb 2011.