Back to resultsGenetics in Non-response to Anti-VEGF Treatment in Exudative AMD (RESPONSE)
Primary Purpose
Macular Degeneration
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration
Eligibility 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
Sites / Locations
- University Center of Ophthalmology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ranibizumab as needed
Arm Description
Outcomes
Primary Outcome Measures
Visual acuity
Change in visual acuity within the observation period
Secondary Outcome Measures
Association between treatment response and genotype
Changes in OCT central retinal thickness / retinal volume
Association between treatment application delay and visual outcome
Association between re-treatment necessity / frequency and intraocular cytokine profiles
Full Information
NCT ID
NCT01213667
First Posted
October 1, 2010
Last Updated
October 24, 2016
Sponsor
University of Cologne
1. Study Identification
Unique Protocol Identification Number
NCT01213667
Brief Title
Genetics in Non-response to Anti-VEGF Treatment in Exudative AMD
Acronym
RESPONSE
Official Title
Pharmacogenetics in Anti-VEGF Treatment Non-responders Suffering Exudative Age-related Macular Degeneration (AMD): Genetic Correlations and Intraocular Cytokine Concentrations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ranibizumab as needed
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
upload (three monthly injections), re-treatment as needed
Primary Outcome Measure Information:
Title
Visual acuity
Description
Change in visual acuity within the observation period
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Association between treatment response and genotype
Time Frame
2 years
Title
Changes in OCT central retinal thickness / retinal volume
Time Frame
2 years
Title
Association between treatment application delay and visual outcome
Time Frame
2 years
Title
Association between re-treatment necessity / frequency and intraocular cytokine profiles
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp S Muether, MD
Organizational Affiliation
Center of Ophthalmology, University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Center of Ophthalmology
City
Cologne
State/Province
NRW
ZIP/Postal Code
50924
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26888975
Citation
Fauser S, Muether PS. Clinical correlation to differences in ranibizumab and aflibercept vascular endothelial growth factor suppression times. Br J Ophthalmol. 2016 Nov;100(11):1494-1498. doi: 10.1136/bjophthalmol-2015-308264. Epub 2016 Feb 17.
Results Reference
derived
PubMed Identifier
25957377
Citation
Saunders DJ, Muether PS, Fauser S. A model of the ocular pharmacokinetics involved in the therapy of neovascular age-related macular degeneration with ranibizumab. Br J Ophthalmol. 2015 Nov;99(11):1554-9. doi: 10.1136/bjophthalmol-2015-306771. Epub 2015 May 8.
Results Reference
derived
PubMed Identifier
21901296
Citation
Koch KR, Muether PS, Hermann MM, Hoerster R, Kirchhof B, Fauser S. Subjective perception versus objective outcome after intravitreal ranibizumab for exudative AMD. Graefes Arch Clin Exp Ophthalmol. 2012 Feb;250(2):201-9. doi: 10.1007/s00417-011-1792-8. Epub 2011 Sep 8.
Results Reference
derived
Learn more about this trial
Genetics in Non-response to Anti-VEGF Treatment in Exudative AMD
We'll reach out to this number within 24 hrs