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

Wet AMD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01310686
• Other study ID #: FVF4990s
• Status: Active, not recruiting
• Start date: April 2011
• Est. completion date: June 2019

Study information

• Verified date: October 2018
• Source: West Coast Retina Medical Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Wet AMD

Locations

Country	Name	City	State
United States	West Coast Retina Medical Group, Inc.	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
West Coast Retina Medical Group, Inc.	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic analysis of patients with chronic wet age-related macular degeneration despite continuous anti-VEGF treatment		This is a one time only blood draw.
Secondary	To evaluate demographic and clinical characteristics in patients treated with anti-VEGF therapy who fail to respond completely.		This is a one time only blood draw and assessment of clinical characteristics.