Overview

This trial is active, not recruiting.

Condition macular degeneration
Treatment ranibizumab
Phase phase 4
Target VEGF
Sponsor University of Cologne
Start date January 2010
End date December 2016
Trial size 110 participants
Trial identifier NCT01213667, RESPONSE2010

Summary

To assess genetic features and intraocular cytokine profiles of non-responders to anti-VEGF treatment of exudative age-related macular degeneration. Also to assess necessity and frequency of pro re nate medical re-treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
ranibizumab Lucentis
upload (three monthly injections), re-treatment as needed

Primary Outcomes

Measure
Visual acuity
time frame: 2 years

Secondary Outcomes

Measure
Association between treatment response and genotype
time frame: 2 years
Changes in OCT central retinal thickness / retinal volume
time frame: 2 years
Association between treatment application delay and visual outcome
time frame: 2 years
Association between re-treatment necessity / frequency and intraocular cytokine profiles
time frame: 2 years

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - active subfoveal CNV related to exudative age-related macular degeneration (all subforms) - age > 60 years - visual acuity > 20/400 - no previous treatment for AMD Exclusion Criteria: - any previous AMD therapy - other CNV types (myopic, parapapillary) - contraindication for ranibizumab treatment - prior study participation for AMD - pregnancy / premenopausal women

Additional Information

Official title Pharmacogenetics in Anti-VEGF Treatment Non-responders Suffering Exudative Age-related Macular Degeneration (AMD): Genetic Correlations and Intraocular Cytokine Concentrations
Principal investigator Philipp S Muether, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Cologne.