We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01310686
First Posted: March 8, 2011
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Arthur D. Fu, MD, West Coast Retina Medical Group, Inc.
  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:


Further study details as provided by Arthur D. Fu, MD, 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. ]

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. ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Wet AMD Non-Responders to Anti-VEGF

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310686


Locations
United States, California
West Coast Retina Medical Group, Inc.
San Francisco, California, United States, 94109
Sponsors and Collaborators
West Coast Retina Medical Group, Inc.
Genentech, Inc.
  More Information

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
First Submitted: March 7, 2011
First Posted: March 8, 2011
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by Arthur D. Fu, MD, 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
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mitogens
Bevacizumab
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents