Overview

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

Status:
Terminated
Trial end date:
2017-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Retina Research Institute, LLC
Collaborators:
Retina-Vitreous Associates Medical Group
West Coast Retina Medical Group, Inc.
Treatments:
BB 1101
Bevacizumab
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
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