Genetics in Non-response to Anti-VEGF Treatment in Exudative AMD

Macular Degeneration Clinical Trial

— RESPONSE  

Official title:

Pharmacogenetics in Anti-VEGF Treatment Non-responders Suffering Exudative Age-related Macular Degeneration (AMD): Genetic Correlations and Intraocular Cytokine Concentrations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01213667
• Other study ID #: RESPONSE2010
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 1, 2010
• Last updated: October 24, 2016
• Start date: January 2010
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Ranibizumab
upload (three monthly injections), re-treatment as needed

Locations

Country	Name	City	State
Germany	University Center of Ophthalmology	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Change in visual acuity within the observation period	2 years	No
Secondary	Association between treatment response and genotype		2 years	No
Secondary	Changes in OCT central retinal thickness / retinal volume		2 years	No
Secondary	Association between treatment application delay and visual outcome		2 years	No
Secondary	Association between re-treatment necessity / frequency and intraocular cytokine profiles		2 years	No