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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01213667
First Posted: October 4, 2010
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Philipp S. Muether, University of Cologne
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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 Philipp S. Muether, University of Cologne:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 2 years ]
    Change in visual acuity within the observation period


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213667


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philipp S. Muether, MD, PhD, University of Cologne
ClinicalTrials.gov Identifier: NCT01213667     History of Changes
Other Study ID Numbers: RESPONSE2010
First Submitted: October 1, 2010
First Posted: October 4, 2010
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Bevacizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents