Myopic Choroidal NeovascularizationNCT02175940
VEGF and PEDF in Patients With Myopic Choroidal Neovascularization
An observational study of Myopic Choroidal Neovascularization and VEGF Aqueous Level, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in eyes with mCNV treated with IVB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopic Choroidal Neovascularization, VEGF Aqueous Level, PEDF Aqueous Level
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2013to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with myopic Choroidal Neovascularization treated with intravitreal ranibizumab at the Medical Retina Department, University of Molise, Campobasso, Italy
Who may be able to join
- pathologic myopia, defined as spherical equivalent >6 diopters and axial length >26 mm
- posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent);
- fluorescein angiography, indocyanine green angiography and optical coherence tomography detection of the subfoveal or juxtafoveal choroidal neovascularization
- clear ocular media;
Who cannot join
- previous treatment for choroidal neovascularization, including the previous intravitreal drug injection or PDT
- presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion
- history of recent myocardial infarction or other thromboembolic events
- ongoing uncontrolled hypertension or glaucoma
- refractive media opacities
- previous eye surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
Medical Retina Department, University of Molise
Cambpobasso, CB, 86100
About this study
Official title: Effect of Intravitreal Ranibizumab Injection on Aqueous Humor Concentrations of Vascular Endothelial Growth Factor and Pigment Epithelium-derived Factor in Patients With Myopic Choroidal Neovascularization.
This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in eyes with mCNV treated with IVB.
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 |
|---|---|---|
| Myopic Choroidal Neovascularization patients | Not described | |
| Control patients undergoing cataract surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular endothelial growth factor (VEGF) aqueous levels
VEGF aqueous levels before and after intravitreal ranibizumab
Measured: 2 months
pigment epithelium-derived factor (PEDF) aqueous levels
PEDF aqueous levels before and after intravitreal ranibizumab
Measured: 2 months
Secondary outcomes (2)
best-corrected visual acuity
Measured: 2 months
central retinal thickness
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionMay 2014
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 Myopic 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-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Ciro Costagliola, Francesco Semeraro, Roberto dell'Omo, Mario R Romano, Fabiana Aceto, Rodolfo Mastropasqua, Antonio Porcellini
- Responsible party
- Principal investigator, Andrea Russo, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175940
- Sponsor's protocol ID
- VEGF001
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
Publications
Costagliola C, Semeraro F, dell'Omo R, Romano MR, Russo A, Aceto F, Mastropasqua R, Porcellini A. Effect of intravitreal ranibizumab injections on aqueous humour concentrations of vascular endothelial growth factor and pigment epithelium-derived factor in patients with myopic choroidal neovascularisation. Br J Ophthalmol. 2015 Jul;99(7):1004-8. doi: 10.1136/bjophthalmol-2014-306465. Epub 2015 Mar 13.
PubMed 25770144
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravitreal Ranibizumab Injection on Aqueous Humor Concentrations of Vascular Endothelial Growth Factor and Pigment Epithelium-derived Factor in Patients With Myopic Choroidal Neovascularization.
- ClinicalTrials.gov ID
- NCT02175940
- Acronym / sponsor ID
- VEGF001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Collaborators
- Ciro Costagliola, Francesco Semeraro, Roberto dell'Omo, Mario R Romano, Fabiana Aceto, Rodolfo Mastropasqua, Antonio Porcellini
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Jun 2014 (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.
This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in eyes with mCNV treated with IVB.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myopic Choroidal Neovascularization patients | – | – |
| Control patients undergoing cataract surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myopic Choroidal Neovascularization treated with intravitreal ranibizumab at the Medical Retina Department, University of Molise, Campobasso, Italy
Key inclusion criteria (4 listed)
- pathologic myopia, defined as spherical equivalent >6 diopters and axial length >26 mm
- posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent);
- fluorescein angiography, indocyanine green angiography and optical coherence tomography detection of the subfoveal or juxtafoveal choroidal neovascularization
- clear ocular media;
Key exclusion criteria (6 listed)
- previous treatment for choroidal neovascularization, including the previous intravitreal drug injection or PDT
- presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion
- history of recent myocardial infarction or other thromboembolic events
- ongoing uncontrolled hypertension or glaucoma
- refractive media opacities
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
vascular endothelial growth factor (VEGF) aqueous levels
Time frame: 2 months
VEGF aqueous levels before and after intravitreal ranibizumab
pigment epithelium-derived factor (PEDF) aqueous levels
Time frame: 2 months
PEDF aqueous levels before and after intravitreal ranibizumab
2 secondary outcomes
best-corrected visual acuity
Time frame: 2 months
central retinal thickness
Time frame: 2 months
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 26 Jun 2014.
- Derived from this study: PubMed 25770144Costagliola C, Semeraro F, dell'Omo R, Romano MR, Russo A, Aceto F, Mastropasqua R, Porcellini A. Effect of intravitreal ranibizumab injections on aqueous humour concentrations of vascular endothelial growth factor and pigment epithelium-derived factor in patients with myopic choroidal neovascularisation. Br J Ophthalmol. 2015 Jul;99(7):1004-8. doi: 10.1136/bjophthalmol-2014-306465. Epub 2015 Mar 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myopic Choroidal Neovascularization and VEGF Aqueous Level, run by Università degli Studi di Brescia at 1 site in Italy.
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 4 inclusion and 6 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 26 Jun 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 Italy. 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?
vascular endothelial growth factor (VEGF) aqueous levels (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT02175940, 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 26 Jun 2014.