Clinical trial NCT01946399: Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF
Official title: Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retinal Vein Occlusion (RVO)
Macular Edema
Lead sponsor: Retina Research Institute, LLC
Sponsor class: OTHER
Collaborators: name: Retina-Vitreous Associates Medical Group
name: West Coast Retina Medical Group, Inc.
First posted: 2013-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy
timeFrame: 6 Months
Secondary outcomes:
measure: Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography
timeFrame: 6 Months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
Study officials:
affiliation: Retina Research Institute
name: Gaurav K Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: