Ozurdex for Macular Edema Post Membrane Peeling

Recruiting in Palo Alto (17 mi)

Overseen byJohn Khadem, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Retina Specialists, PC

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of vision and lead to swelling, or macular edema. Despite surgery to remove the scar tissue(membrane peeling), residual swelling of the retina may continue to interfere with vision. In this study the investigators will inject an implantable steroid device into the back, fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration (FDA) for decreasing swelling due to another condition in the eye. This study will help to find out whether or not this device Ozurdex™ is also effective for reducing the swelling of the retina in patients who have already had surgery to remove scar tissue on the retina.

Research Team

John Khadem, MD

Principal Investigator

Retina Specialists, PC

Eligibility Criteria

Inclusion Criteria

Patients with macular edema who have had previous epi-retinal membrane peeling surgery for macular edema associated with epi-retinal membranes.

All patients must have clear ocular media/lenses determined visually by the investigator in order to permit good quality stereoscopic fundus photography, fluorescein angiography and ocular coherence tomography.

Treatment Details

Interventions

Dexamethasone (Corticosteroid)

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Ozurdex 6 months or longer after surgeryExperimental Treatment1 Intervention

Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery

Group II: Ozurdex 3 months after surgeryExperimental Treatment1 Intervention

Patients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant

Group III: No OzurdexActive Control1 Intervention

Arm 1(control) - Patients who have had epi-retinal membrane peeling and have macular edema at least 3 months (90 days) after surgery. These patients will followed without Ozurdex. The patients will be treated with current standard of care, including topical and intravitreal or subtenon's medication.

Dexamethasone is already approved in Canada, Japan for the following indications: