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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02762188
Date of registration:	25/04/2016
Prospective Registration:	No
Primary sponsor:	Brugmann University Hospital
Public title:	Genetic Biomarkers for the Response to Anti-VEGF (Vascular Endothelial Growth Factor).Treatment in Wet Age-related Macular Degeneration (Wet ARMD)
Scientific title:	Genetic Biomarkers for the Response to Anti-VEGF (Vascular Endothelial Growth Factor).Treatment in Wet Age-related Macular Degeneration (Wet ARMD)
Date of first enrolment:	August 1, 2013
Target sample size:	501
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02762188
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Belgium

Contacts

Name:	Laurence Postelmans, MD
Address:
Telephone:
Email:
Affiliation:	CHU Brugmann

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Age-Related Macular Degeneration

Intervention(s)

Device: Genotype analysis

Primary Outcome(s)

Presence of Pigment Epithelial Detachment (yes/no) [Time Frame: 3 months after treatment]

Presence of Pigment Epithelial Detachment (yes/no) [Time Frame: 4 months after treatment]

Presence of Subretinal Fluid (yes/no) [Time Frame: 3 months after treatment]

Presence of Intra Retinal Cysts (yes/no) [Time Frame: Baseline]

Central foveal thickness (µm) [Time Frame: 6 months after treatment]

Number of injections received per year [Time Frame: 1 year]

Presence of Intra Retinal Cysts (yes/no) [Time Frame: 4 months after treatment]

Presence of Subretinal Fluid (yes/no) [Time Frame: Baseline]

Presence of Intra Retinal Cysts (yes/no) [Time Frame: 3 months after treatment]

Snellen visual acuity test result [Time Frame: Baseline]

Snellen visual acuity test result [Time Frame: 12 months after treatment]

Snellen visual acuity test result [Time Frame: 6 months after treatment]

Central foveal thickness (µm) [Time Frame: 12 months after treatment]

Snellen visual acuity test result [Time Frame: 3 months after treatment]

Central foveal thickness (µm) [Time Frame: Baseline]

Central foveal thickness (µm) [Time Frame: 3 months after treatment]

Presence of Pigment Epithelial Detachment (yes/no) [Time Frame: Baseline]

Presence of Subretinal Fluid (yes/no) [Time Frame: 4 months after treatment]

Secondary Outcome(s)

Secondary ID(s)

CHUB-SAMBA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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