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Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept (Eylea-2014)

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ClinicalTrials.gov Identifier: NCT02125864
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
ANCA ROALD, Oslo University Hospital

Brief Summary:

The purpose of this study is to examine the plasma concentration of vascular endothelial growth factor (VEGF) after standard treatment with one of the newest growth factor inhibitors, aflibercept (Eylea).

Patients with exudative age-related macular degeneration (AMD) are treated today with anti-growth factors (anti-VEGF). Eylea appears to have a longer duration of action in the eye and a more powerful effect on the edema in the macula than previously used growth factor inhibitors. This means that the disease can be controlled with fewer number of injections into the eye and the investigators can therefore reduce the risk of complications associated with this type of treatment.

It is unclear what the plasma VEGF concentration after treatment with Eylea into the eye in patients with wet age-related macular degeneration is.


Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Drug: Aflibercept Phase 4

Detailed Description:

Macular edema secondary to exudative age-related macular degeneration is treated today primarily with vascular endothelial growth factor inhibitors, anti-VEGF.

There are currently four anti-VEGF drugs that are either approved or off-label used in ophthalmology. Pegaptanib (Macugen, Pfizer), ranibizumab (Lucentis, Novartis) aflibercept (Eylea, Bayer) and bevacizumab Avastin, Roche) . They have different molecules and pharmacodynamics .

VEGF plays an important role in many physiological and pathophysiological mechanisms. Studies have shown that even low-dose intravitreal treatment with bevacizumab leads to significant reduction of VEGF plasma concentration up to a month after treatment in patients with exudative AMD.

No significant systemic effect could be detected after intravitreal administration of ranibizumab or pegaptanib.

The purpose of this study is :

  • To determine if intravitreal treatment with Eylea affects VEGF plasma levels in patients with exudative AMD
  • How long after intravitreal injection is VEGF plasma concentration affected?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept in Patients With Exudative Age-related Macular Degeneration
Study Start Date : April 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aflibercept Drug: Aflibercept



Primary Outcome Measures :
  1. Mean change in VEGF plasma concentration (pg/mL) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mean change in Visual Acuity as measured with the Snellen chart [ Time Frame: 6 months ]
  2. Central Retinal Thickness as measured by Optical coherence tomography expressed in microns [ Time Frame: 6 months ]
  3. Number of non-responders [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women with exudative AMD
  • Central Retinal Thickness ≥ 250 microns
  • Best corrected visual acuity 20/25-20/320
  • Age ≥ 60 years
  • Only one eye will be applicable for recruitment
  • Informed signed consent according to International Conference on Harmonisation Good Clinical Practice should be in place prior to study .

Exclusion Criteria:

  • Bilateral disease
  • Treatment with intravitreal injections in the past three months
  • Patients who have previously undergone vitrectomy
  • Choroidal neovascular membrane secondary to other disease than AMD
  • Macula edema of other etiology than wet AMD
  • Intraocular pressure ≥ 30 mmHg in mydriasis
  • Active uveitis or infectious condition in the study eye
  • Patients using systemic anti inflammatory therapy ( steroids)
  • Patients using systemic anti-VEGF treatment
  • Blod pressure which is not well regulated
  • Dialysis or in need of transplantation resulting from renal failure
  • Heart attack, stroke, transient ischemic attack in the last 6 months
  • New York Heart Association class II , III , IV
  • Known allergy to aflibercept , fluorescein or povidone iodine
  • Unable to follow the study procedures
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ANCA ROALD, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02125864    
Other Study ID Numbers: 2014-000103-27
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by ANCA ROALD, Oslo University Hospital:
AMD
VEGF
Aflibercept
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases