A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
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| ClinicalTrials.gov Identifier: NCT00168324 |
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Recruitment Status :
Completed
First Posted : September 15, 2005
Results First Posted : August 26, 2009
Last Update Posted : September 18, 2013
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
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Drug: 700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
Other Name: Posurdex® |
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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.
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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® |
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Sham Comparator: Sham Injection followed by 700 µg Dexamethasone
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
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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. |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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.
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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): 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 |
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00168324 History of Changes |
| Other Study ID Numbers: |
206207-008 |
| First Posted: | September 15, 2005 Key Record Dates |
| Results First Posted: | August 26, 2009 |
| Last Update Posted: | September 18, 2013 |
| Last Verified: | July 2013 |
Additional relevant MeSH terms:
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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 |