Ozurdex for Macular Edema Post Membrane Peeling

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
John Khadem, Retina Specialists, PC
ClinicalTrials.gov Identifier:
NCT01273727
First received: January 7, 2011
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Epiretinal Membrane
Cellophane Maculopathy
Macular Edema
Retinal Edema
Drug: Dexamethasone
Drug: dexamethasone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ozurdex in Treatment of Macular Edema Post Membrane Peeling

Resource links provided by NLM:


Further study details as provided by Retina Specialists, PC:

Primary Outcome Measures:
  • mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2010
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Ozurdex
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.
Experimental: Ozurdex 3 months after surgery
Patients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant
Drug: Dexamethasone
intravitreal implant 0.7 mg 6 month duration
Other Name: Ozurdex
Experimental: Ozurdex 6 months or longer after surgery
Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery
Drug: dexamethasone
intravitreal implant 0.7 mg duration 6 months
Other Name: ozurdex

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • Best corrected visual acuity 20/50 or better in the study eye
  • Sub-macular hemorrhage in the study eye
  • Sub-retinal fibrosis in the study eye
  • Macular hole in the study eye
  • Active inflammatory disease of the study eye
  • Choroidal neovascularization in the study eye
  • History of other ophthalmic disorders with the exception of cataract or previous cataract extraction in the study eye
  • Active ocular infection in the study eye
  • Previous subfoveal laser treatment in the study eye
  • Previous verteporfin photodynamic therapy in the study eye
  • Any systemic medical condition that would preclude them from undergoing surgery with monitored sedation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273727

Locations
United States, New York
Retina Specialists PC
New York, New York, United States, 10011
Sponsors and Collaborators
Retina Specialists, PC
Allergan
Investigators
Principal Investigator: John Khadem, MD Retina Specialists, PC
  More Information

No publications provided

Responsible Party: John Khadem, Principal Investigator, Retina Specialists, PC
ClinicalTrials.gov Identifier: NCT01273727     History of Changes
Other Study ID Numbers: 3433-001
Study First Received: January 7, 2011
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Retina Specialists, PC:
epiretinal membrane
macular pucker
cellophane maculopathy
macular edema
retinal edema
ozurdex
dexamethasone
intravitreal implant

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Diseases
Papilledema
Epiretinal Membrane
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 26, 2014