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Neovascularization, Pathologic clinical trials

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NCT ID: NCT02876198 Completed - Clinical trials for Retinal Neovascularization

Study of the Modification of the Retinal Nerve Fiber Layer in Patients Treated With Intravitreous Injection of Anti-VEGF

IVT-RNFL
Start date: July 1, 2016
Phase:
Study type: Observational

The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. The VEGF stimulates endothelial cells' proliferation and migration. It also increases microvascular permeability. If the VEGFs have proven their efficiency in the decrease of choroidal neovascular proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown. Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have an incidence on the loss of retinal nerve fibers.

NCT ID: NCT02857894 Terminated - Clinical trials for Choroidal Neovascularization

Genetic Factors of Idiopathic Polypoidal Vasculopathies in the ATM Gene (Ataxia Telangiectasia Mutated)

ATM
Start date: November 5, 2015
Phase:
Study type: Observational

Polypoidal choriodal vasculopathy (PCV) is an ophthalmologic disease, characterized by vascular abnormalities of the walls of small choroidal vessels, reproducing the specific aspect of polyps (cluster aspect). PCV is one of the "boundary-forms" of age related macular degeneration. These vasculopathies can be idiopathic. Following the radiotherapy treatments of active and occult-typed neovessels in Age-Related Macular Degeneration (ARMD), 10% of the patients would present typical polypoidal vasculopathic lesions. These polypoidal secondary lesions have been induced by radiotherapy treatment and may show an increased sensibility to radiation in these patients. Such an increase of radiosensibility is noticed in ataxia telangiectasia syndrome, in relation to the ATM gene mutations. The secondary or idiopathic polypoidal vasculopathic lesions are to be brought closer to telangiectasias in Ataxia Telangiectasia. Considering the iatrogenic component of radiotherapy in the secondary forms of ataxia telangiectasia, it seems legitimate to search for predisposing variants to polypoidal vasculopathies in the ATM gene. Considering the frequency of PCV worldwide, it seems important to identify the predisposing genetic factors of the ATM gene. These biomarkers to the pathology might enable us to offer prevention (reinforced protection against radiations, including light) and to develop therapeutics (recruitment of other kinases, ATM's partners, in the stability and cellular control of DNA).

NCT ID: NCT02857517 Recruiting - Clinical trials for Idiopathic Choroidal Neovascularization

Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV.

NCT ID: NCT02825277 Recruiting - Preeclampsia Clinical Trials

Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies

EVUPA
Start date: December 2013
Phase: N/A
Study type: Interventional

Introduction Preeclampsia (PE) and intra-uterine growth restriction (IUGR) are two major pregnancy complications related to chronic utero-placental hypoperfusion. Three-dimensional power Doppler (3DPD) angiography has been used for the evaluation of utero-placental vascularisation and three vascular indices have been calculated: the vascularisation index (VI), flow index (FI) and vascularisation-FI (VFI). However, several technical endpoints hinder the clinical use of 3DPD as physical characteristics and machine settings may affect 3DPD indices, and so its clinical significance is not yet clear. Objectives The primary objective is to better understand the clinical significance of 3DPD indices by evaluating the relationship between these indices and placental morphometry. Secondary objectives are (i) to determine the impact of machine settings and physical characteristics on 3DPD indices, and (ii) to evaluate physio-pathological placental vascularisation patterns. Methods and analysis This is a prospective controlled study. We expect to include 112 women: 84 with normal pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for PE and/or IUGR prediction (unpublished data)). Within 72 h before planned or semi-urgent caesarean section, utero-placental 3DPD images with five different machine settings will be acquired. Placentas will be collected and examined after surgery and stereological indices (volume density, surface density, length density) calculated. The 3DPD indices (VI, FI and VFI) of the placenta and adjacent myometrium will be calculated. Correlation between Doppler and morphological indices will be evaluated by Pearson or Spearman tests. Agreement between 3DPD indices and morphological indices will be assessed by Bland and Altman plots. The impact of Doppler settings and maternal characteristics on 3DPD indices will be evaluated with a multivariate linear regression model.

NCT ID: NCT02821247 Completed - Clinical trials for Macular Degeneration

Prospective Observational Study to Assess Effectiveness of Intravitreal Aflibercept in Patients With Wet Macular Degeneration in Greece

PERSEUS-GR
Start date: July 1, 2016
Phase:
Study type: Observational

This is a prospective, observational, multi-center, study. The study will be conducted in approximately 12 ophthalmological clinics and practices throughout Greece. It is planned to collect data on treatment of wet Age related Macular Degeneration (wAMD) from about 120 patients for which the decision to treat with intravitreal aflibercept injections is made at the discretion of the attending physician, according to his/her medical practice. Visits will be performed at baseline, aflibercept first injection (if different from enrollment) and at 12 and 24 months. The 12 and 24 month comprise the data collection visits during which any data generated in the period preceding these visits will be recorded. All required information for the purposes of this study will be collected using electronic Case Record Form (eCRF). The web-based electronic data capture (EDC) application will be specifically designed for the needs of the study and will adhere to all applicable data protection regulations and requirements with regard to electronic records. The study observation period for each patient enrolled in this study is the time from the beginning of treatment with intravitreal aflibercept injection up to two years or until discontinuation of intravitreal aflibercept injection-treatment due to any reason including withdrawal of consent or patient loss from follow-up.

NCT ID: NCT02802852 Completed - Clinical trials for Critical Limb Ischemia

Proteomics and Stem Cell Therapy as a New Vascularization Strategy

Start date: June 2016
Phase: N/A
Study type: Interventional

Neovascularization (NV) is the innate capability to enlarge collateral arteries ("arteriogenesis"), and to stimulate growth of new capillaries, arterioles and venules at the tissue level ("angiogenesis"). Patients with Chronic Limb-threatening Ischemia (CLI) present with forefoot rest-pain, ulceration and/or gangrene. They require risky and costly revascularization operations to avoid amputation. The investigators hypothesize that their inadequate NV can be modulated to restore this capability. By correcting impediments to NV in an out-patient setting, the investigators expect to facilitate CLI management. While the following impediments to NV are complex, the solution is not. Arteriogenesis necessitates endothelial cell activation in small collaterals as blood is offloaded away from the occluded artery. Shear stress provides this stimulus, but is attenuated caudal to multi-level arterial occlusive disease. The "arteriogenesis switch" is not turned on. Furthermore, the lack of nutritive oxygenated blood inflow and the accumulation of toxic metabolic by-products are adverse to synthetic pathways in the ischemic tissue. Additionally, protein "distress" signals cannot be effectively disseminated by the ischemic tissue, and the reparative progenitor cells they are supposed to mobilize cannot effectively home back to the ischemic tissue to orchestrate NV. The CLI patient is especially disadvantaged by having diminished function and number of circulating progenitor cells (CPC). Lastly these elderly, often diabetic, patients are less able to fend off infection. An FDA approved external programmed pneumatic compression device (PPCD) was used to restore the shear stress stimulus required for arteriogenesis. It also enhances oxygenated nutritive arterial inflow, clears waste products of metabolism (increased venous and lymphatic outflow), and helps distress proteins reach the central circulation and mobilized progenitor cells to return to the ischemic tissue. We corrected the progenitor cell and immunologic impairment with granulocyte colony stimulating factor (G-CSF), FDA approved for stem cell mobilization and immunological boost in the setting of cancer chemotherapy. The preliminary data show clinical, angiographic, hemodynamic and biochemical evidence for enhanced NV. The purpose for this study is to enroll 25 patients to reproduce the biochemical data to support a large scale clinical trial.

NCT ID: NCT02797704 Terminated - Clinical trials for Corneal Neovascularization

Subconjunctival Aflibercept (EYLEA®) for the Treatment of Corneal Neovascularization

Start date: March 2, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this current study is to prospectively evaluate the influence of a single subconjunctival aflibercept injection on the regression of corneal neovascularization. Twenty patients with corneal neovascularization who are candidates for anti VEGF treatment (by the discretion of a corneal specialist) will be included in this study. The patients will be treated with a single subconjunctival injection of 0.08 ml aflibercept (25 mg/ml) in a single quarter of the conjunctiva, near the limbus in a proximity to the area of pathological neovascularization. Regression of neovascularization will be documented.

NCT ID: NCT02759796 Completed - Breast Cancer Clinical Trials

Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

Start date: November 2015
Phase: N/A
Study type: Interventional

It is a single-center, prospective, randomized and controlled study focused in microsurgical autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography for the study of the vascularization of DIEP flaps. The aim of the study is to determine whether there are differences in complications and aesthetic results when ICG is used to discard the poorly vascularized areas of the flap. The study includes adult women undergoing unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There are two groups. In group 1, the investigators use the usual clinical criteria to discard the poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape the flap.

NCT ID: NCT02666547 Terminated - Clinical trials for Pathological Angiogenesis

68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis

Start date: March 2014
Phase: Phase 1
Study type: Interventional

This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or 18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent tumor.

NCT ID: NCT02625376 Terminated - Clinical trials for Age-related Macular Degeneration

Resveratrol for Exudative Age-Related Macular Degeneration

AGED
Start date: August 6, 2015
Phase: N/A
Study type: Interventional

This is an interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.