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

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:

MedlinePlus related topics: Edema

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Cumulative Response Rate of 15 or More Letter Improvement [ Time Frame: Up to 180 Days ] [ Designated as safety issue: No ]
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:

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 ] [ 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 at each visit are presented.
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:	599
Study Start Date:	October 2004
Study Completion Date:	October 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

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

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: NCT00168324

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

No publications provided


Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00168324 History of Changes
Other Study ID Numbers:	206207-008
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:


Macular Edema Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases 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 Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015