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

October 10, 2018 updated by: Arthur D. Fu, MD, West Coast Retina Medical Group, Inc.

Genotypic Evaluation of Chronic Exudative Macular Degeneration Despite Monthly Anti-Vascular Endothelial Growth Factor (VEGF) Therapy

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • West Coast Retina Medical Group, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Wet Age-Related Macular Degeneration

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Wet AMD Non-Responders to Anti-VEGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
This is a one time only blood draw.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
This is a one time only blood draw and assessment of clinical characteristics.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Coast Retina Medical Group, Inc.

Collaborators

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 7, 2011

First Posted (Estimate)

March 8, 2011

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVF4990s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wet AMD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe