NCT01282411

Brief Summary

Ozurdex(TM) has recently been FDA approved for use in macular edema secondary to retinal vein occlusion. It remains unclear how quickly the drug works and for how long as the initial studies did not have frequent anatomic monitoring. This study will utilize frequent Spectral domain OCT imaging to better understand the onset of treatment effectiveness and duration of action on the anatomic thickness of the retina, in addition to distinguishing structural abnormalities of responders from non-responders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

January 21, 2011

Last Update Submit

July 26, 2016

Conditions

Retinal Vein Occlusions

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Branch retinal vein occlusion (BRVO) Central retinal Vein occlusion (CRVO)

You may qualify if:

  • Patients diagnosed with BRVO/CRVO who are otherwise eligible to receive treatment with Ozurdex (TM)

You may not qualify if:

  • Patients younger than 21 years of age, unwilling or unable to grant informed consent, participation in a clinical trial within the 30 days prior to enrollment. Patients receiving any other ocular therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Retina Institute

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Gaurav K Shah, MD

    Barnes Retina Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gaurav K. Shah, MD

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 25, 2011

Study Start

February 1, 2010

Primary Completion

May 1, 2011

Study Completion

July 1, 2011

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

US(1)