Genetics in Non-response to Anti-VEGF Treatment in Exudative AMD

NCT ID: NCT01213667

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ranibizumab as needed

Group Type OTHER

Ranibizumab

Intervention Type DRUG

upload (three monthly injections), re-treatment as needed

Interventions

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Ranibizumab

upload (three monthly injections), re-treatment as needed

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Philipp S. Muether

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philipp S Muether, MD

Role: PRINCIPAL_INVESTIGATOR

Center of Ophthalmology, University of Cologne

Locations

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University Center of Ophthalmology

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26888975 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25957377 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21901296 (View on PubMed)

Other Identifiers

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RESPONSE2010

Identifier Type: -

Identifier Source: org_study_id