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

NCT01946399 | Terminated

• 1 other identifier: Ozurdex RVO 2013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vein Occlusion (RVO); Macular Edema

Outcome Measures

Primary Outcomes (1)

• Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy

  6 Months

Secondary Outcomes (1)

• Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography

  6 Months

Study Arms (1)

Ozurdex implant

OTHER

Intravitreal injection of Ozurdex implant

Drug: Ozurdex implant

Interventions

Ozurdex implant DRUG

Intravitreal injection of Dexamethasone implant

Also known as: Dexamethasone implant

Ozurdex implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Retina Research Institute, LLC: lead
• Retina-Vitreous Associates Medical Group: collaborator
• West Coast Retina Medical Group, Inc.: collaborator

Study Sites (1)

The Retina Institute

St Louis, Missouri, 63128, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Gaurav K Shah, MD

  Retina Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gaurav K. Shah, MD

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

US (1)