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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01273727
Other study ID # 3433-001
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received January 7, 2011
Last updated May 12, 2015
Start date June 2010
Est. completion date April 2014

Study information

Verified date May 2015
Source Retina Specialists, PC
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
Dexamethasone
intravitreal implant 0.7 mg 6 month duration
dexamethasone
intravitreal implant 0.7 mg duration 6 months

Locations

Country Name City State
United States Retina Specialists PC New York New York

Sponsors (2)

Lead Sponsor Collaborator
Retina Specialists, PC Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment 6 months Yes
Secondary mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment 6 months No
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