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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Macular Edema; Retinal Vein Occlusion	Drug: 700 µg Dexamethasone; Drug: 350 µg Dexamethasone; Other: Sham Injection	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	599 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Study Start Date :	October 2004
Actual Primary Completion Date :	March 2008
Actual Study Completion Date :	October 2008

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Cumulative Response Rate of 15 or More Letter Improvement [ Time Frame: Up to 180 Days ]
   The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.

Secondary Outcome Measures :

1. Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Day 90, Day 180 ]
   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 at each visit are presented.
2. Change From Baseline in Retinal Thickness in the Study Eye [ Time Frame: Baseline, Day 90, Day 180 ]
   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.
3. Percentage of Patients With a Change From Baseline in BCVA by Category [ Time Frame: Baseline, Day 90 ]
   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.
4. Percentage of Patients With a Change From Baseline in BCVA by Category [ Time Frame: Baseline, Day 180 ]
   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.

Eligibility Criteria

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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:

• 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

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

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Locations

United States, California
Los Angeles, California, United States
Australia
Sydney, Australia
Austria
Graz, Austria
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Czech Republic
Brno, Czech Republic
France
Creteil, France
Germany
Karlsruhe, Germany
Israel
Rehovot, Israel
Mexico
Tabacalera, Mexico
Philippines
Makati, Philippines
Portugal
Coimbra, Portugal
South Africa
Arcadia, South Africa
Taiwan
Kaohsiung, Taiwan

Sponsors and Collaborators

Allergan

Investigators

Study Director:	Medical Director	Allergan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00168324 History of Changes
Other Study ID Numbers:	206207-008
First Posted:	September 15, 2005
Results First Posted:	August 26, 2009
Last Update Posted:	September 18, 2013
Last Verified:	July 2013

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