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CompletedNCT01282411Updated Jul 27, 2016

Anatomic Outcomes Following Ozurdex Injections

An observational study in Retinal Vein Occlusions, sponsored by Barnes Retina Institute. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-07-27.

Sponsored by Barnes Retina Institute · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
21 Years and older
Sex
All
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Study 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.

Read the detailed description

Focal laser therapy has been the gold standard for the treatment of macular edema secondary to branch vein occlusion (BRVO), though it has not been shown to be effective for central vein occlusion (CRVO). Intravitreal corticosteroids have been shown in many case series to be effective at diminishing macular edema secondary to both BRVO and CRVO. Sustained drug delivery models have been sought after to relieve the need for frequent injections. Ozurdex has recently been found to be effective for the treatment of macular edema following BRVO or CRVO and has been approved by the FDA for these indications. The onset of effectiveness and duration of action on the anatomic thickness of the retina have not yet been demonstrated. In addition, it is uncertain as to when the clinician can label the patient as a responder or nonresponder. We also believe this study will help identify patients that may need more frequent dosing schedules.

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Conditions studied

  • Retinal Vein Occlusions
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In context

Retinal Vein Occlusion

282 studies on the registry are indexed under Retinal Vein Occlusion; 27 are open to participants now.

This study's enrollment of 10 is below the median of 122 across 62 observational studies indexed under Retinal Vein Occlusion.

Browse Retinal Vein Occlusion studies →

Lead sponsor

Barnes Retina Institute is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (actual)
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Study locations

1 site
  • Barnes Retina Institute
    St. Louis, Missouri 63110, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01282411
Lead sponsor
Barnes Retina Institute
Collaborators
Allergan
Responsible party
Rhonda Weeks (Gaurav K. Shah, MD, Barnes Retina Institute) — Principal investigator
First posted
Jan 25, 2011
Start date
Feb 2010
Primary completion
May 2011
Completion
Jul 2011
Last update
Jul 27, 2016

Study contacts

Gaurav K Shah, MD
principal investigator · Barnes Retina Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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