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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Philipp S. Muether, University of Cologne
ClinicalTrials.gov Identifier:
NCT01213667
First received: October 1, 2010
Last updated: October 17, 2013
Last verified: October 2013
  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: 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 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Cologne

Additional 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
Study First Received: October 1, 2010
Last Updated: October 17, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014