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

October 24, 2016 updated by: Philipp S. Muether, University of Cologne

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50924
        • University Center of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ranibizumab as needed
Drug: Ranibizumab
upload (three monthly injections), re-treatment as needed
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 2 years
Change in visual acuity within the observation period
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between treatment response and genotype
Time Frame: 2 years
2 years
Changes in OCT central retinal thickness / retinal volume
Time Frame: 2 years
2 years
Association between treatment application delay and visual outcome
Time Frame: 2 years
2 years
Association between re-treatment necessity / frequency and intraocular cytokine profiles
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Philipp S Muether, MD, Center of Ophthalmology, University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimate)

October 4, 2010

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESPONSE2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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