A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00168298
First received: September 12, 2005
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.


Condition Intervention Phase
Macular Edema
Retinal Vein Occlusion
Drug: 700 µg Dexamethasone
Drug: 350 µg Dexamethasone
Other: Sham Injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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: Day 180 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Retinal Thickness in the Study Eye [ Time Frame: Baseline, Day 90, Day 180 ] [ Designated as safety issue: No ]
    Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.

  • Percentage of Patients With a Change From Baseline in BCVA by Category [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.

  • Percentage of Patients With a Change From Baseline in BCVA by Category [ Time Frame: Baseline, Day 180 ] [ Designated as safety issue: No ]
    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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.


Enrollment: 668
Study Start Date: November 2004
Study Completion Date: September 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
Drug: 700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
Other Name: Posurdex®
Experimental: 350 µg Dexamethasone followed by 700 µg Dexamethasone
350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Drug: 700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
Other Name: Posurdex®
Drug: 350 µg Dexamethasone
350 µg Dexamethasone intravitreal implant administered on Day 0.
Other Name: Posurdex®
Sham Comparator: Sham Injection followed by 700 µg Dexamethasone
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Drug: 700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
Other Name: Posurdex®
Other: Sham Injection
Sham injection on Day 0.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 18 years of age or older with macular edema resulting from retinal vein occlusion
  • Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
  • Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

  • Known anticipated need for ocular surgery within next 12 months
  • History of glaucoma or current high eye pressure requiring more than 1 medication
  • Diabetic retinopathy
  • Uncontrolled systemic disease
  • Known steroid-responder
  • Use of systemic steroids
  • Use of warfarin/heparin
  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: NCT00168298

Locations
United States, Texas
Houston, Texas, United States
Brazil
Sao Paulo, Brazil
Canada, Ontario
Mississauga, Ontario, Canada
Colombia
Bogota, Colombia
Hong Kong
Kowloon, Hong Kong
India
Tamil Nadu, India
Italy
Udine, Italy
Korea, Republic of
Seoul, Korea, Republic of
New Zealand
Auckland, New Zealand
Poland
Poznan, Poland
Singapore
Singapore, Singapore
Spain
Alicante, Spain
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00168298     History of Changes
Other Study ID Numbers: 206207-009
Study First Received: September 12, 2005
Results First Received: July 15, 2009
Last Updated: July 15, 2013
Health Authority: United States: 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 October 20, 2014