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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:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01660802
First received: August 7, 2012
Last updated: September 19, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central Retinal Thickness as assessed by Optical Computer Tomography (OCT) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Fluorescein leakage as assessed by fluorescein angiography (FA) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Enrollment: 262
Study Start Date: August 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 Posterior Segment Drug Delivery System (DEX PS DDS) intravitreal injection in the study eye on Day 1 and Month 6.
Drug: 700 μg Dexamethasone
700 μg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) intravitreal injection in the study eye at Day 1 and Month 6 or Month 6 only.
Other Name: Ozurdex®
Sham and 700 μg Dexamethasone
Sham Posterior Segment Drug Delivery System administered in the study eye on Day 1 and 700 μg Dexamethasone Posterior Segment Drug Delivery System intravitreal injection at Month 6.
Drug: 700 μg Dexamethasone
700 μg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) intravitreal injection in the study eye at Day 1 and Month 6 or Month 6 only.
Other Name: Ozurdex®
Other: Sham
Sham Posterior Segment Drug Delivery System administered in the study eye on Day 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01660802

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01660802     History of Changes
Other Study ID Numbers: 206207-020
Study First Received: August 7, 2012
Last Updated: September 19, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Thrombosis
Vascular Diseases
Venous Thrombosis
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 23, 2014