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

Not Applicable

Terminated

• Conditions: Retinal Vein Occlusion (RVO); Macular Edema
• Interventions: Drug: Ozurdex implant

• Registration Number: NCT01946399
• Lead Sponsor: Retina Research Institute, LLC

Brief 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.

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2016-09-01
• Study Completion: 2017-09-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ozurdex implant	Ozurdex implant	Intravitreal injection of Ozurdex implant

Primary Outcome Measures

Name	Time	Method
Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy	6 Months

Secondary Outcome Measures

Name	Time	Method
Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography	6 Months

Trial Locations

Locations (1)

The Retina Institute; 🇺🇸 Saint Louis, Missouri, United States