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

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01946399
• Other study ID #: Ozurdex RVO 2013
• Status: Terminated
• Phase: N/A
• First received: September 16, 2013
• Last updated: November 29, 2017
• Start date: September 2013
• Est. completion date: September 1, 2017

Study information

• Verified date: November 2017
• Source: Retina Research Institute, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion
• Retinal Vein Occlusion (RVO)

Intervention

Drug:
• Ozurdex implant
Intravitreal injection of Dexamethasone implant

Locations

Country	Name	City	State
United States	The Retina Institute	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Retina Research Institute, LLC	Retina-Vitreous Associates Medical Group, West Coast Retina Medical Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy		6 Months
Secondary	Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography		6 Months