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TerminatedNCT01946399Updated Dec 2, 2017

Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

An interventional study of Ozurdex implant in Retinal Vein Occlusion (RVO) and Macular Edema, sponsored by Retina Research Institute, LLC. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-02.

Sponsored by Retina Research Institute, LLC · Not applicable, Interventional, and Treatment

Why this study was terminated
enrollment not met
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.

Read the detailed description

To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.

02

Conditions studied

  • Retinal Vein Occlusion (RVO)
  • Macular Edema
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Retina Research Institute, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months.

Exclusion criteria

Exclusion Criteria:

  • Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes
  • Interval surgical intervention, such as cataract surgery, that may confound visual outcomes.
  • Pregnancy
  • Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including:
  • Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases)
  • Advanced glaucoma
  • Aphakic eyes with rupture or missing posterior lens capsule
  • Eyes with anterior chamber intraocular lens and missing posterior lens capsule
  • Patients with known hypersensitivity to components of this product
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Other
    Ozurdex implant

    Intravitreal injection of Ozurdex implant

    Drug: Ozurdex implant

Interventions

  • DrugOzurdex implant

    Intravitreal injection of Dexamethasone implant

    Also known as: Dexamethasone implant

06

What researchers measure

Primary outcomes

  1. Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy

    Time frame: 6 Months

Secondary outcomes

  1. Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography

    Time frame: 6 Months

07

Study locations

1 site
  • The Retina Institute
    Saint Louis, Missouri 63128, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01946399
Lead sponsor
Retina Research Institute, LLC
Collaborators
Retina-Vitreous Associates Medical Group, West Coast Retina Medical Group, Inc.
Responsible party
Rhonda Weeks (Gaurav K. Shah, MD, Retina Research Institute, LLC) — Principal investigator
First posted
Sep 19, 2013
Start date
Sep 2013
Primary completion
Sep 1, 2016
Completion
Sep 1, 2017
Last update
Dec 2, 2017

Study contacts

Gaurav K Shah, MD
principal investigator · Retina Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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