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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01213667
Acronym
RESPONSE
Enrollment
110
Registered
2010-10-04
Start date
2010-01-31
Completion date
2017-12-31
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

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.

Interventions

DRUGRanibizumab

upload (three monthly injections), re-treatment as needed

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual acuity2 yearsChange in visual acuity within the observation period

Secondary

MeasureTime frame
Association between treatment response and genotype2 years
Changes in OCT central retinal thickness / retinal volume2 years
Association between treatment application delay and visual outcome2 years
Association between re-treatment necessity / frequency and intraocular cytokine profiles2 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026