NCT01213667

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

7.9 years

First QC Date

October 1, 2010

Last Update Submit

October 24, 2016

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Change in visual acuity within the observation period

    2 years

Secondary Outcomes (4)

  • Association between treatment response and genotype

    2 years

  • Changes in OCT central retinal thickness / retinal volume

    2 years

  • Association between treatment application delay and visual outcome

    2 years

  • Association between re-treatment necessity / frequency and intraocular cytokine profiles

    2 years

Study Arms (1)

ranibizumab as needed

OTHER
Drug: Ranibizumab

Interventions

RanibizumabDRUG

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

Also known as: Lucentis
ranibizumab as needed

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active subfoveal CNV related to exudative age-related macular degeneration (all subforms)
  • age \> 60 years
  • visual acuity \> 20/400
  • no previous treatment for AMD

You may not qualify if:

  • any previous AMD therapy
  • other CNV types (myopic, parapapillary)
  • contraindication for ranibizumab treatment
  • prior study participation for AMD
  • pregnancy / premenopausal women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Center of Ophthalmology

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Publications (3)

  • 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.

    PMID: 26888975DERIVED

  • 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.

    PMID: 25957377DERIVED

  • 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.

    PMID: 21901296DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Philipp S Muether, MD

    Center of Ophthalmology, University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

DE(1)