Trial | NCT01946399  Report issue

Title

Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF
Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    10
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.
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.
Study Started
Sep 30
2013
Primary Completion
Sep 01
2016
Study Completion
Sep 01
2017
Last Update
Dec 02
2017

Drug Ozurdex implant

Intravitreal injection of Dexamethasone implant

  • Other names: Dexamethasone implant

Ozurdex implant Other

Intravitreal injection of Ozurdex implant

Criteria 

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:

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
No Results Posted