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

Information source: Retina Research Institute, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinal Vein Occlusion (RVO); Macular Edema

Intervention: Ozurdex implant (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Retina Research Institute, LLC

Official(s) and/or principal investigator(s):
Gaurav K Shah, MD, Principal Investigator, Affiliation: Retina Research Institute

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy

Secondary outcome: Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

The Retina Institute, St. Louis, Missouri 63128, United States; Recruiting
Erika Hoehn, BS, Phone: 314-367-1181, Ext: 2511, Email: erika.hoehn@rc-stl.com
Rhonda Weeks, Phone: 314-367-1181, Ext: 2609, Email: rhonda.weeks@rc-stl.com
Gaurav K Shah, MD, Principal Investigator
Additional Information

Starting date: September 2013
Last updated: July 24, 2015

Page last updated: August 23, 2015

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