Polypoidal Choroidal VasculopathyNCT04714242
OCTA and Polypoidal Choroidal Vasculopathy
An observational study of Polypoidal Choroidal Vasculopathy, run by Federico II University at 1 site in Italy.
Trial summary
To investigate the structural and vascular features of choroid in patients affected by PCV after Ranibizumab intravitreal injection. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- Ranibizumab Injection
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2019to 20 Dec 2020
- 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 60 to 80 years
- All sexes
- Adult, Older adult
Study population: The participans were older than 60 years with diagnosis of polypoidal choroidal vasculopathy They did not present other ophthalmological diseases.
Who may be able to join
- age older than 60 years
- diagnosis of polypoidal choroidal vasculopathy
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT-A images.
Who cannot join
- age older than 80 years
- absence of diagnosis of polypoidal choroidal vasculopathy
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT-A images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Choroid and Choriocapillary Changes in Polypoidal Choroidal Vasculopathy After Intravitreal Anti-VEGF Therapy
To investigate the structural and vascular features of choroid in patients affected by PCV after Ranibizumab intravitreal injection.
Read the detailed description
Polypoidal choroidal vasculopathy represents a distinct form of choroidal neovascularization.
The study investigated the changes in choroidal vascular network after anti-VEGF therapy using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- Ranibizumab Injection
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab InjectionDrug
Also called Lucentis
Three monthly intravitreal injections of Ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent anti-VEGF therapy | intravitreal Anti-VEGF therapy: Three monthly intravitreal injections Receives: Drug: Ranibizumab Injection | |
| Control Group | Healthy eyes without actual and previous ocular diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of vascular features of choroid in polypoidal choroidal vasculopathy after intravitreal injections of Ranibizumab
The effectiveness of Ranibizumab injections for treating PCV using optical optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: choriocapillaris vessel density.
Measured: 12 Months
Secondary outcomes (1)
Study of structural features of choroid in polypoidal choroidal vasculopathy after intravitreal
The effectiveness of Ranibizumab injections for treating PCV using optical optical coherence tomography. The parameters analyzed by optical coherence tomography were: subfoveal choroidal thickness.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start15 Jan 2019
- Primary completion15 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoidal Choroidal VasculopathyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Gilda Cennamo, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714242
- Sponsor's protocol ID
- 1401/21
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroid and Choriocapillary Changes in Polypoidal Choroidal Vasculopathy After Intravitreal Anti-VEGF Therapy
- ClinicalTrials.gov ID
- NCT04714242
- Acronym / sponsor ID
- 1401/21
- Conditions
- Polypoidal Choroidal Vasculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 19 Jan 2021 (actual)
- 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.
To investigate the structural and vascular features of choroid in patients affected by PCV after Ranibizumab intravitreal injection.
Detailed description
Polypoidal choroidal vasculopathy represents a distinct form of choroidal neovascularization.
The study investigated the changes in choroidal vascular network after anti-VEGF therapy using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients underwent anti-VEGF therapy | – | Drug: Ranibizumab Injectionintravitreal Anti-VEGF therapy: Three monthly intravitreal injections |
| Control Group | – | –Healthy eyes without actual and previous ocular diseases |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 60 years with diagnosis of polypoidal choroidal vasculopathy They did not present other ophthalmological diseases.
Key inclusion criteria (4 listed)
- age older than 60 years
- diagnosis of polypoidal choroidal vasculopathy
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT-A images.
Key exclusion criteria (4 listed)
- age older than 80 years
- absence of diagnosis of polypoidal choroidal vasculopathy
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT-A images.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ranibizumab InjectionAlso: LucentisThree monthly intravitreal injections of Ranibizumab | Drug | Patients underwent anti-VEGF therapy |
Primary outcome
Study of vascular features of choroid in polypoidal choroidal vasculopathy after intravitreal injections of Ranibizumab
Time frame: 12 Months
The effectiveness of Ranibizumab injections for treating PCV using optical optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: choriocapillaris vessel density.
1 secondary outcome
Study of structural features of choroid in polypoidal choroidal vasculopathy after intravitreal
Time frame: 12 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 19 Jan 2021.
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Polypoidal Choroidal Vasculopathy
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.
Gilda Cennamo principal investigator
Federico II University
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 Polypoidal Choroidal Vasculopathy, run by Federico II University 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 4 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 19 Jan 2021. 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?
Study of vascular features of choroid in polypoidal choroidal vasculopathy after intravitreal injections of Ranibizumab (time frame: 12 Months). 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 19 Jan 2021.