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Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00799227
Recruitment Status : Completed
First Posted : November 27, 2008
Results First Posted : August 4, 2014
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Vitrectomy Drug: Dexamethasone Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : December 1, 2009
Actual Study Completion Date : December 1, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: 700 µg Dexamethasone Implant
700 µg dexamethasone implant in the study eye at Day 1
 Drug: Dexamethasone
700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.
Other Names:
  • Posurdex®
  • OZURDEX®


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Central Retinal Thickness in the Study Eye [ Time Frame: Baseline, Week 26 ]
    Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.


Secondary Outcome Measures :
  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Week 26 ]
    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.

  2. Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye [ Time Frame: Baseline, Week 26 ]
    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.

  3. Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye [ Time Frame: Baseline, Week 26 ]
    Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older with diabetic macular edema
  • History of vitrectomy
  • Central retinal thickness ≥ 275 µm
  • Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

Exclusion Criteria:

  • Known anticipated need for ocular surgery during the study period
  • History of glaucoma or current high eye pressure requiring more than 1 medication
  • Uncontrolled systemic disease
  • Known allergy to the study medication
  • Known steroid-responder
  • Use of systemic steroids
  • Female subjects that are pregnant, nursing or planning a pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799227


Locations
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United States, North Carolina
Charlotte, North Carolina, United States
Australia, New South Wales
Sydney, New South Wales, Australia
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00799227    
Other Study ID Numbers: 206207-018
First Posted: November 27, 2008    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: April 23, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents