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Genetic Biomarkers for the Response to Anti-VEGF (Vascular Endothelial Growth Factor).Treatment in Wet Age-related Macular Degeneration (Wet ARMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02762188
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Laurence Postelmans, Brugmann University Hospital

Brief Summary:

Age-Related Macular Degeneration (ARMD) is the most common cause of blindness in the adult population of the Western World. It affects the macula - the region of the retina most rich in photoreceptors and responsible for central vision. The ethiology of ARMD remains poorly understood. Population-based studies have demonstrated a complex ethiology, with contributions from a combination of genetic and environmental factors.

Two major forms of ARMD are clinically distinguishable: the dry and wet form. The latter represents the more aggressive clinical subgroup, and is characterized by the abnormal growth of new blood vessels (neovascularization) under the macula, thus leading to the accumulation of fluid under the retina, bleeding, progression to fibrosis, and finally loss of central vision.

The pathogenesis of this neovascularization is not fully understood, although the VEGF pathway is well known to be involved in angiogenesis and was implicated in the development of the new vessels under the macula. The VEGFs are the most specific and potent stimulators of the angiogenesis.

Molecules that bind and inactivate the VEGF have been developed for the treatment of ARMD and they are applied in ARMD clinic through intra vitreal injections.The difference seen in response to anti VEGF treatment for ARMD between the patients is suggestive for the presence of factors influencing the effect of the drug. Some of these could be genetic variants within genes involved in ARMD pathogenesis or VEGF pathway. Few associations with markers within genes previously found to be related with the pathogenesis of ARMD have been found. It remains unknown whether variants involved in the anti VEGF treatment response could influence the therapeutic outcome.

The purpose of this trial is to evaluate the association between a panel of selected polymorphic markers in the VEGF pathway and the response to therapy with anti VEGF antibody for ARMD. The hypothesis is that the individual genotype influences the response to the anti VEGF. This can lead to identification of genetic biomarkers allowing treatment individualization and optimization of the visual outcomes.


Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Device: Genotype analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Genetic Biomarkers for the Response to Anti-VEGF (Vascular Endothelial Growth Factor).Treatment in Wet Age-related Macular Degeneration (Wet ARMD)
Actual Study Start Date : August 1, 2013
Actual Primary Completion Date : January 18, 2018
Actual Study Completion Date : January 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: wet ARMD patients
Patients with the wet form of ARMD who receive or have received in the past anti VEGF intra vitreal injections. Diagnosis of wet ARMD is made based on clinical data-visual acuity, fundus presence of subretinal fluid and/or haemorrhage and/or hard exudates, fundus photographs -color and red free, optical coherence tomography (SD-OCT), fluorescein angiography and indocyanine green angiography showing the presence and activity of subretinal neovascularisation.
Device: Genotype analysis

After signing informed consent, a blood sample is taken and DNA extracted according to standard procedures. The samples are genotyped with the Mass Array iPlex Gold. Processing of the data is done using the previously described protocol by Lambrechts and co.

Statistical analysis will be done to evaluate the association between the different genetic variants and the clinical outcomes collected during the standard of care follow-up for ARMD.





Primary Outcome Measures :
  1. Snellen visual acuity test result [ Time Frame: Baseline ]
    The visual acuity test is used to determine the smallest letters you can read on a standardized chart (Snellen chart).

  2. Snellen visual acuity test result [ Time Frame: 3 months after treatment ]
    The visual acuity test is used to determine the smallest letters you can read on a standardized chart (Snellen chart).

  3. Snellen visual acuity test result [ Time Frame: 6 months after treatment ]
    The visual acuity test is used to determine the smallest letters you can read on a standardized chart (Snellen chart).

  4. Snellen visual acuity test result [ Time Frame: 12 months after treatment ]
    The visual acuity test is used to determine the smallest letters you can read on a standardized chart (Snellen chart).

  5. Number of injections received per year [ Time Frame: 1 year ]
  6. Central foveal thickness (µm) [ Time Frame: Baseline ]
    Measured by optical coherence tomography (Heidelberg & Zeiss)

  7. Central foveal thickness (µm) [ Time Frame: 3 months after treatment ]
    Measured by optical coherence tomography (Heidelberg & Zeiss)

  8. Central foveal thickness (µm) [ Time Frame: 6 months after treatment ]
    Measured by optical coherence tomography (Heidelberg & Zeiss)

  9. Central foveal thickness (µm) [ Time Frame: 12 months after treatment ]
    Measured by optical coherence tomography (Heidelberg & Zeiss)

  10. Presence of Intra Retinal Cysts (yes/no) [ Time Frame: Baseline ]
    Tested by optical coherence tomography (Heidelberg & Zeiss)

  11. Presence of Intra Retinal Cysts (yes/no) [ Time Frame: 3 months after treatment ]
    Tested by optical coherence tomography (Heidelberg & Zeiss)

  12. Presence of Intra Retinal Cysts (yes/no) [ Time Frame: 4 months after treatment ]
    Tested by optical coherence tomography (Heidelberg & Zeiss)

  13. Presence of Subretinal Fluid (yes/no) [ Time Frame: Baseline ]
    Tested by optical coherence tomography (Heidelberg & Zeiss)

  14. Presence of Subretinal Fluid (yes/no) [ Time Frame: 3 months after treatment ]
    Tested by optical coherence tomography (Heidelberg & Zeiss)

  15. Presence of Subretinal Fluid (yes/no) [ Time Frame: 4 months after treatment ]
    Tested by optical coherence tomography (Heidelberg & Zeiss)

  16. Presence of Pigment Epithelial Detachment (yes/no) [ Time Frame: Baseline ]
    Tested by optical coherence tomography (Heidelberg & Zeiss)

  17. Presence of Pigment Epithelial Detachment (yes/no) [ Time Frame: 3 months after treatment ]
    Tested by optical coherence tomography (Heidelberg & Zeiss)

  18. Presence of Pigment Epithelial Detachment (yes/no) [ Time Frame: 4 months after treatment ]
    Tested by optical coherence tomography (Heidelberg & Zeiss)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with the wet form of ARMD who receive or have received in the past anti VEGF intra vitreal injections

Exclusion Criteria:

  • Patients whi had received treatments other than anti VEGF, before the use of anti-VEGF
  • Patients without follow-up
  • Patients receiving anti-VEGF because of another pathology than ARMD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762188


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Laurence Postelmans, MD CHU Brugmann
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Responsible Party: Laurence Postelmans, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02762188    
Other Study ID Numbers: CHUB-SAMBA
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurence Postelmans, Brugmann University Hospital:
wet ARMD
VEGF
intra vitreal injections
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases