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Corticosteroid

Ozurdex for Macular Edema Post Membrane Peeling

Phase 2 & 3
Waitlist Available
Led By John Khadem, MD
Research Sponsored by Retina Specialists, PC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 60 Other Conditions

Summary

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.

Eligible Conditions
  • Macular Edema
  • Macular Pucker
  • Retinal Edema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Dexamethasone
FDA approved

Find a Location

Who is running the clinical trial?

Retina Specialists, PCLead Sponsor
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,650 Total Patients Enrolled
57 Trials studying Macular Edema
11,384 Patients Enrolled for Macular Edema
John Khadem, MDPrincipal InvestigatorRetina Specialists, PC
~2 spots leftby Jan 2026