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