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

Phase 4

• Conditions: Macular Degeneration
• Interventions: Drug: Ranibizumab

• Registration Number: NCT01213667
• Lead Sponsor: University of Cologne

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ranibizumab as needed	Ranibizumab	-

Primary Outcome Measures

Name	Time	Method
Visual acuity	2 years	Change in visual acuity within the observation period

Secondary Outcome Measures

Name	Time	Method
Changes in OCT central retinal thickness / retinal volume	2 years
Association between treatment application delay and visual outcome	2 years
Association between re-treatment necessity / frequency and intraocular cytokine profiles	2 years
Association between treatment response and genotype	2 years

Trial Locations

Locations (1)

University Center of Ophthalmology; 🇩🇪 Cologne, NRW, Germany