NCT01310686

Brief 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.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

8.2 years

First QC Date

March 7, 2011

Last Update Submit

October 10, 2018

Conditions

Wet AMD

Keywords

wet AMD anti-VEGFGenetic analysis of patients with Wet AMD who have not responded fully to anti-VEGF treatments

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (1)

Wet AMD Non-Responders to Anti-VEGF

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Wet Age-Related Macular Degeneration

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Coast Retina Medical Group, Inc.

San Francisco, California, 94109, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

US(1)