Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery
This study has been completed.
Sponsor:
Northern California Retina Vitreous Associates
Collaborator:
Allergan
Information provided by:
Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier:
NCT01284478
First received: January 25, 2011
Last updated: October 3, 2012
Last verified: October 2012
| Tracking Information | |||||
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| First Received Date ICMJE | January 25, 2011 | ||||
| Last Updated Date | October 3, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
BEST CORRECTED VISUAL ACUITY (ETDRS) [ Time Frame: AT DAY 180 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
BEST CORRECTED VISUAL ACUITY (ETDRS) [ Time Frame: AT DAY 90 ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT01284478 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY [ Time Frame: 90 and 180 DAYS ] [ Designated as safety issue: Yes ] CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME |
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| Original Secondary Outcome Measures ICMJE |
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY [ Time Frame: 90 DAYS ] [ Designated as safety issue: Yes ] CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery | ||||
| Official Title ICMJE | Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery | ||||
| Brief Summary | The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Dexamethasone Implant
Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally |
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| Study Arm (s) | Dexamethasone Implant
Patients will be treated with the Ozurdex (Dexamethasone Implant)
Intervention: Drug: Dexamethasone Implant |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 6 | ||||
| Completion Date | October 2012 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01284478 | ||||
| Other Study ID Numbers ICMJE | NCRVA-2011-Ozurdex-16-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | RAHUL KHURANA, M.D. / PRINCIPAL INVESTIGATOR, NORTHERN CALIFORNIA RETINA VITREOUS ASSOCIATES | ||||
| Study Sponsor ICMJE | Northern California Retina Vitreous Associates | ||||
| Collaborators ICMJE | Allergan | ||||
| Investigators ICMJE |
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| Information Provided By | Northern California Retina Vitreous Associates | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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