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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Cologne.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01213667
First received: October 1, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  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:

Drug Information available for: Ranibizumab
U.S. FDA Resources

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 2012
Estimated Primary Completion Date: December 2011 (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

Contacts
Contact: Philipp S Muether, MD +49 221 478 ext 4328 philmuether@mac.com

Locations
Germany
University Center of Ophthalmology Recruiting
Cologne, NRW, Germany, 50924
Contact: Philipp S. Muether     +49 221 478 ext 4328     philmuether@mac.com    
Principal Investigator: Philipp S. Muether, MD            
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: Dr. med. Philipp S. Muether, Center of Ophthalmology, Dept. of Vitreoretinal Sugery
ClinicalTrials.gov Identifier: NCT01213667     History of Changes
Other Study ID Numbers: RESPONSE2010
Study First Received: October 1, 2010
Last Updated: October 1, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 22, 2013