Ozurdex for Macular Edema Post Membrane Peeling

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01273727
Study type	Interventional
Source	Retina Specialists, PC
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	June 2010
Completion date	April 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04292912` - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema	Phase 1
Recruiting	`NCT05976139` - Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies	N/A
Completed	`NCT03660345` - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME	Phase 3
Completed	`NCT03660371` - ILM Peeling in PDR Patients Undergoing PPV for VH	N/A
Completed	`NCT01660802` - Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)	Phase 3
Completed	`NCT01908816` - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.	Phase 3
Completed	`NCT04592419` - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)	Phase 3
Completed	`NCT02867735` - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema	Phase 1
Completed	`NCT02623673` - Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema	N/A
Terminated	`NCT01946399` - Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF	N/A
Completed	`NCT01428388` - Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion	N/A
Completed	`NCT01231633` - Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)	N/A
Recruiting	`NCT01023113` - To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation	N/A
Terminated	`NCT00918554` - Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis	Phase 4
Terminated	`NCT00969293` - Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion	Phase 1
Completed	`NCT00970957` - Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion	Phase 3
Completed	`NCT00476593` - Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications	N/A
Completed	`NCT00668239` - Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser	N/A
Completed	`NCT00411970` - 20- Versus 23- Gauge System for Pars Plana Vitrectomy	Phase 4
Terminated	`NCT01939691` - Macular Edema Nepafenac vs. Difluprednate Uveitis Trial	Phase 4