Neovascular Age-related Macular DegenerationNCT03509623
Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration
A study testing Blood sampling through direct peripheral venous puncture in people with Neovascular Age-related Macular Degeneration, run by University Hospital of Patras at 1 site in Greece.
Trial summary
This study aims to evaluate coagulation parameters in treatment naive patients with neovascular age-related macular degeneration (AMD). Treatment naive patients with neovascular AMD, scheduled to undergo treatment with intravitreal injections of aflibercept will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Blood sampling through direct peripheral venous puncture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGreece
- Study dates
- 2 Aug 2017to 27 Apr 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- treatment naive patients with neovascular AMD scheduled to undergo treatment with intravitreal aflibercept(IVA) in one eye.
Who cannot join
- patients under systemic treatment with anti-VEGF agents
- patients under intravitreal anti-VEGF treatment in both eyes
- patients unwilling to return 1 week and 1 month after the first IVA
- patients undergoing dialysis, with chronic liver disease or malignancy, under systemic treatment with nonsteroidal anti-inflammatory drugs or under anticoagulation therapy
- patients with a history of any ATE event during the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With Age Related Macular Degeneration
This study aims to evaluate coagulation parameters in treatment naive patients with neovascular age-related macular degeneration (AMD). Treatment naive patients with neovascular AMD, scheduled to undergo treatment with intravitreal injections of aflibercept will be enrolled in the study. Blood samples will be collected before the first intravitreal injection and at 7 and 30 days after aflibercept administration.
Read the detailed description
Neovascular age-related macular degeneration is one of the leading causes of severe visual loss in the aging population. Intravitreal anti-VEGF agents constitute the mainstay in the treatment of neovascular AMD.
Aflibercept is a recombinant fusion protein targeting vascular endothelial growth factor A(VEGF A) and placenta growth factor (PlGF), developed for intravitreal administration in conditions such as neovascular age related macular degeneration, macular edema due to retinal vein occlusion, diabetic macular edema or myopic choroidal neovascularization. However, treatment with anti-VEGFs like aflibercept, carries a potential risk of arterial thromboembolic events, including stroke and myocardial infarction.
- Being tested
- Blood sampling through direct peripheral venous puncture
- Keywords
- neovascular age-related macular degeneration, aflibercept, intravitreal anti-VEGF, coagulation, platelet count, D-Dimer, Fibrinogen
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling through direct peripheral venous punctureDiagnostic test
Fasting blood samples will be collected 10-15 minutes before the first intravitreal injection of aflibercept and at 7 and 30 days post-injection using a 19-gauge needle under minimum stasis. Blood coagulation parameters will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Blood coagulation and aflibercept | Experimental | Blood sampling through direct peripheral venous puncture will be collected from treatment naive patients commencing treatment with intravitreal injections of aflibercept for neovascular AMD before the first intravitreal injection of aflibercept and at 7 and 30 days post-injection. Blood coagulation parameters will be evaluated at each timepoint. Receives: Diagnostic Test: Blood sampling through direct peripheral venous puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Platelet count
Peripheral blood sample analysis
Measured: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Change in Plasma fibrinogen levels
Peripheral blood sample analysis
Measured: Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
Change in Plasma D-dimer levels
Peripheral blood sample analysis
Measured: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Change in Activated partial thromboplastin time (aPTT)
Peripheral blood sample analysis
Measured: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Change in Prothrombin time (PT)
Peripheral blood sample analysis
Measured: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Change in International normalized ratio (INR)
Peripheral blood sample analysis
Measured: Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
Change in Protein S levels
Peripheral blood sample analysis
Measured: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Change in Protein C levels
Peripheral blood sample analysis
Measured: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start2 Aug 2017
- Primary completion26 Mar 2018
- Study completion27 Apr 2018
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 Neovascular Age-related Macular DegenerationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509623
- Sponsor's protocol ID
- 516/26.7.2017
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2018
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Georgakopoulos CD, Makri OE, Pallikari A, Kagkelaris K, Plotas P, Grammenou V, Emmanuil A. Effect of intravitreal injection of aflibercept on blood coagulation parameters in patients with age-related macular degeneration. Ther Adv Ophthalmol. 2020 Feb 11;12:2515841420903929. doi: 10.1177/2515841420903929. eCollection 2020 Jan-Dec.
PubMed 32095777
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03509623
- Acronym / sponsor ID
- 516/26.7.2017
- Keywords
- neovascular age-related macular degeneration, aflibercept, intravitreal anti-VEGF, coagulation, platelet count, D-Dimer, Fibrinogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 26 Apr 2018 (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.
This study aims to evaluate coagulation parameters in treatment naive patients with neovascular age-related macular degeneration (AMD). Treatment naive patients with neovascular AMD, scheduled to undergo treatment with intravitreal injections of aflibercept will be enrolled in the study. Blood samples will be collected before the first intravitreal injection and at 7 and 30 days after aflibercept administration.
Detailed description
Neovascular age-related macular degeneration is one of the leading causes of severe visual loss in the aging population. Intravitreal anti-VEGF agents constitute the mainstay in the treatment of neovascular AMD.
Aflibercept is a recombinant fusion protein targeting vascular endothelial growth factor A(VEGF A) and placenta growth factor (PlGF), developed for intravitreal administration in conditions such as neovascular age related macular degeneration, macular edema due to retinal vein occlusion, diabetic macular edema or myopic choroidal neovascularization. However, treatment with anti-VEGFs like aflibercept, carries a potential risk of arterial thromboembolic events, including stroke and myocardial infarction.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood coagulation and aflibercept | Experimental | Diagnostic Test: Blood sampling through direct peripheral venous punctureBlood sampling through direct peripheral venous puncture will be collected from treatment naive patients commencing treatment with intravitreal injections of aflibercept for neovascular AMD before the first intravitreal injection of aflibercept and at 7 and 30 days post-injection. Blood coagulation parameters will be evaluated at each timepoint. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- treatment naive patients with neovascular AMD scheduled to undergo treatment with intravitreal aflibercept(IVA) in one eye.
Key exclusion criteria (5 listed)
- patients under systemic treatment with anti-VEGF agents
- patients under intravitreal anti-VEGF treatment in both eyes
- patients unwilling to return 1 week and 1 month after the first IVA
- patients undergoing dialysis, with chronic liver disease or malignancy, under systemic treatment with nonsteroidal anti-inflammatory drugs or under anticoagulation therapy
- patients with a history of any ATE event during the last 6 months
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 |
|---|---|---|
| Blood sampling through direct peripheral venous punctureFasting blood samples will be collected 10-15 minutes before the first intravitreal injection of aflibercept and at 7 and 30 days post-injection using a 19-gauge needle under minimum stasis. Blood coagulation parameters will be evaluated. | Diagnostic test | Blood coagulation and aflibercept |
Primary outcome
Change in Platelet count
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Plasma fibrinogen levels
Time frame: Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Plasma D-dimer levels
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Activated partial thromboplastin time (aPTT)
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Prothrombin time (PT)
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in International normalized ratio (INR)
Time frame: Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Protein S levels
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Protein C levels
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
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 7 May 2018.
- Derived from this study: PubMed 32095777Georgakopoulos CD, Makri OE, Pallikari A, Kagkelaris K, Plotas P, Grammenou V, Emmanuil A. Effect of intravitreal injection of aflibercept on blood coagulation parameters in patients with age-related macular degeneration. Ther Adv Ophthalmol. 2020 Feb 11;12:2515841420903929. doi: 10.1177/2515841420903929. eCollection 2020 Jan-Dec.
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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?
A study testing Blood sampling through direct peripheral venous puncture in people with Neovascular Age-related Macular Degeneration, run by University Hospital of Patras at 1 site in Greece.
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 5 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 7 May 2018. 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 Greece. 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?
Change in Platelet count (time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration). The study lists 8 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 NCT03509623, 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 7 May 2018.