Clinical trial NCT03509623: Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration
Official title: Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With Age Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neovascular Age-related Macular Degeneration
Keywords: neovascular age-related macular degeneration
aflibercept
intravitreal anti-VEGF
coagulation
platelet count
D-Dimer
Fibrinogen
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 47
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* treatment naive patients with neovascular AMD scheduled to undergo treatment with intravitreal aflibercept(IVA) in one eye.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Platelet count
timeFrame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
measure: Change in Plasma fibrinogen levels
timeFrame: Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
measure: Change in Plasma D-dimer levels
timeFrame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
measure: Change in Activated partial thromboplastin time (aPTT)
timeFrame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
measure: Change in Prothrombin time (PT)
timeFrame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
measure: Change in International normalized ratio (INR)
timeFrame: Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
measure: Change in Protein S levels
timeFrame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
measure: Change in Protein C levels
timeFrame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Secondary outcomes:
Other outcomes:
Locations:
city: Patra
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
References:
citation: 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.