A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)
This study is currently recruiting participants.
Verified April 2013 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01571557
First received: April 3, 2012
Last updated: April 18, 2013
Last verified: April 2013
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Purpose
This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.
| Condition | Intervention |
|---|---|
|
Macular Edema Retinal Vein Occlusion |
Drug: dexamethasone 700 ug intravitreal implant |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
U.S. FDA Resources
Further study details as provided by Allergan:
Primary Outcome Measures:
- Change from Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from Baseline in Central Retinal Thickness [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 560 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
OZURDEX®
OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
|
Drug: dexamethasone 700 ug intravitreal implant
dexamethasone 700 ug intravitreal implant administered according to standard of care.
Other Name: OZURDEX®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with macular oedema due to retinal vein occlusion
Criteria
Inclusion Criteria:
- Diagnosis of macular edema following retinal vein occlusion
- Prescribed OZURDEX®
Exclusion Criteria:
- Previous treatment with OZURDEX®
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571557
Contacts
| Contact: Allergan Inc. | clinicaltrials@allergan.com |
Locations
| Germany | |
| Recruiting | |
| Berlin, Germany | |
| Not yet recruiting | |
| Ludwigshafen, Germany | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
More Information
No publications provided
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01571557 History of Changes |
| Other Study ID Numbers: | MAF/AGN/OPH/RET/011 |
| Study First Received: | April 3, 2012 |
| Last Updated: | April 18, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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 |
Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 22, 2013