Polypoidal Choroidal VasculopathyPCVNCT02381730
Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment
A study testing Intravitreal aflibercept in people with Polypoidal Choroidal Vasculopathy, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
Trial summary
Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- Intravitreal aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2014to 31 Aug 2017
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active polypoidal choroidal vasculopathy,
- Visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32)
- Age above 45
- No prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability
- Intravitreal injection of aflibercept is indicated by current clinical recommendations
Who cannot join
- Simultaneous treatment with another anti-VEGM agent
- Diabetic retinopathy
- Personal history of vitrectomy or uveitis
- Personal history laser photocoagulation and/or verteporphin phototherapy
- Tear in the pigmentary epithelium
- Chorioretinitis scar
Show all 9Show fewer
- Macular atrophy in the pigmentary epithelium
- Treatment with corticosteroids
- Eye surgery less than 3 months before inclusion
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Lyon Croix Rousse
Lyon
Fondation Ophtalmologique A. de Rothschild
Paris, 75019
Centre Médical de la Rétine Maison Rouge
Strasbourg, 67000
About this study
Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD.
This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- Intravitreal aflibercept
- 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.
Intravitreal afliberceptDrug
Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Experimental | Not described Receives: Drug: Intravitreal aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJan 2014
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
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.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine Mauget-Faysse, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381730
- Sponsor's protocol ID
- 2013-A01717-38
- Acronym
- PCV
- Status last verified
- Dec 2017
- First submitted
- 5 Mar 2015
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment
- ClinicalTrials.gov ID
- NCT02381730
- Acronym / sponsor ID
- PCV / 2013-A01717-38
- Conditions
- Polypoidal Choroidal Vasculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jan 2014
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 6 Mar 2015 (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.
Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD.
This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Experimental | Drug: Intravitreal aflibercept |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Active polypoidal choroidal vasculopathy,
- Visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32)
- Age above 45
- No prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability
- Intravitreal injection of aflibercept is indicated by current clinical recommendations
Key exclusion criteria (9 listed)
- Simultaneous treatment with another anti-VEGM agent
- Diabetic retinopathy
- Personal history of vitrectomy or uveitis
- Personal history laser photocoagulation and/or verteporphin phototherapy
- Tear in the pigmentary epithelium
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 |
|---|---|---|
| Intravitreal afliberceptPatient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD) | Drug | Aflibercept |
Primary outcome
Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection
Time frame: 28 weeks
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 8 Dec 2017.
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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.
Martine Mauget-Faysse principal investigator
Fondation Ophtalmologique A. de Rothschild
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal aflibercept in people with Polypoidal Choroidal Vasculopathy, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
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 5 inclusion and 9 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection (time frame: 28 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 8 Dec 2017.