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Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01660802
First Posted: August 9, 2012
Last Update Posted: June 8, 2015
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.
Information provided by (Responsible Party):
Allergan
  Purpose
This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.

Condition Intervention Phase
Macular Edema Drug: 700 μg Dexamethasone Other: Sham Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, 6 Months ]
    BCVA is measured 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 means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.


Secondary Outcome Measures:
  • Average Change From Baseline in BCVA in the Study Eye [ Time Frame: Baseline, 6 Months ]
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.

  • Change From Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 ]
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.

  • Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 ]
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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.


Enrollment: 262
Study Start Date: September 2012
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 700 μg Dexamethasone
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Drug: 700 μg Dexamethasone
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Other Name: Ozurdex®
Sham Comparator: Sham
Sham administered in the study eye on Day 1.
Drug: 700 μg Dexamethasone
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Other Name: Ozurdex®
Other: Sham
Sham administered in the study eye on Day 1.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

Exclusion Criteria:

  • History of glaucoma, ocular hypertension or optic nerve head change
  • Any active bacterial, viral, parasitic, or fungal infections in either eye
  • Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
  • History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
  • Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
  • Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start
  • Use of topical ophthalmic corticosticosteroids within 2 weeks of study start
  Contacts and Locations
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): NCT01660802


Locations
China
Beijing, China
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01660802     History of Changes
Other Study ID Numbers: 206207-020
First Submitted: August 7, 2012
First Posted: August 9, 2012
Results First Submitted: April 2, 2015
Results First Posted: June 8, 2015
Last Update Posted: June 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action