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Genetics Study of Wet Age-Related Macular Degeneration (AMD) Non-Responders to Vascular Endothelial Growth Factor (VEGF) Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Arthur D. Fu, MD, West Coast Retina Medical Group, Inc.
ClinicalTrials.gov Identifier:
NCT01310686
First received: March 7, 2011
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

To obtain a genotypic analysis of patients with chronic exudative age-related macular degeneration noted to have subretinal or intraretinal edema despite continuous monthly Anti-VEGF therapy.


Condition
Wet AMD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genotypic Evaluation of Chronic Exudative Macular Degeneration Despite Monthly Anti-Vascular Endothelial Growth Factor (VEGF) Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by West Coast Retina Medical Group, Inc.:

Primary Outcome Measures:
  • Genetic analysis of patients with chronic wet age-related macular degeneration despite continuous anti-VEGF treatment [ Time Frame: This is a one time only blood draw. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate demographic and clinical characteristics in patients treated with anti-VEGF therapy who fail to respond completely. [ Time Frame: This is a one time only blood draw and assessment of clinical characteristics. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Wet AMD Non-Responders to Anti-VEGF

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with Wet Age-Related Macular Degeneration

Criteria

Inclusion Criteria:

  • Ability to provide written informed consent for participation in this study
  • Subjects diagnoses of neovascular AMD who are on a monthly anti-VEGF regimen (have had >10 or more ranibizumab and/or bevacizumab injections within the last year) and who still have intra-retinal or subretinal fluid as confirmed by the Investigator

Exclusion Criteria:

  • Subjects with a Pigment Epithelial Detachment Exclusively
  • Subjects with Serous Pigment Epithelial Detachments
  • Subjects with history of the following:

idiopathic polypoidal choroidal vasculopathy

  • pathologic degenerative myopia
  • central serous chorioretinopathy
  • familial drusen
  • adult onset foveal pattern dystrophy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310686

Locations
United States, California
West Coast Retina Medical Group, Inc.
San Francisco, California, United States, 94107
Sponsors and Collaborators
West Coast Retina Medical Group, Inc.
Genentech
  More Information

No publications provided

Responsible Party: Arthur D. Fu, MD, Principal Investigator, West Coast Retina Medical Group, Inc.
ClinicalTrials.gov Identifier: NCT01310686     History of Changes
Other Study ID Numbers: FVF4990s
Study First Received: March 7, 2011
Last Updated: February 24, 2012
Health Authority: United States: Western Institutional Review Board

Keywords provided by West Coast Retina Medical Group, Inc.:
wet AMD anti-VEGF
Genetic analysis of patients with Wet AMD who have not responded fully to anti-VEGF treatments

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mitogens
 Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013