Genetics in Non-response to Anti-VEGF Treatment in Exudative AMD (RESPONSE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Philipp S. Muether, University of Cologne Identifier:
First received: October 1, 2010
Last updated: May 28, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Macular Degeneration
Drug: Ranibizumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacogenetics in Anti-VEGF Treatment Non-responders Suffering Exudative Age-related Macular Degeneration (AMD): Genetic Correlations and Intraocular Cytokine Concentrations

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in visual acuity within the observation period

Secondary Outcome Measures:
  • Association between treatment response and genotype [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Changes in OCT central retinal thickness / retinal volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Association between treatment application delay and visual outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Association between re-treatment necessity / frequency and intraocular cytokine profiles [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ranibizumab as needed Drug: Ranibizumab
upload (three monthly injections), re-treatment as needed
Other Name: Lucentis


Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts 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
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Please refer to this study by its identifier: NCT01213667

University Center of Ophthalmology
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
Principal Investigator: Philipp S Muether, MD Center of Ophthalmology, University of Cologne
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Philipp S. Muether, MD, PhD, University of Cologne Identifier: NCT01213667     History of Changes
Other Study ID Numbers: RESPONSE2010 
Study First Received: October 1, 2010
Last Updated: May 28, 2015
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Physiological Effects of Drugs processed this record on May 24, 2016