DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
This study is currently recruiting participants.
Verified August 2012 by Centro de Pesquisa Rubens Siqueira
Sponsor:
Centro de Pesquisa Rubens Siqueira
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Rubens Camargo Siqueira, Centro de Pesquisa Rubens Siqueira
ClinicalTrials.gov Identifier:
NCT01662518
First received: August 8, 2012
Last updated: August 9, 2012
Last verified: August 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 8, 2012 | ||||||||
| Last Updated Date | August 9, 2012 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Best Corrected Visual Acuity (BCVA) [ Time Frame: Day 0 - Day 180 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01662518 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Change in central foveal thickness at 48 weeks [ Time Frame: 1 day to 48 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO) | ||||||||
| Official Title ICMJE | A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO) | ||||||||
| Brief Summary | This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion. |
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| Detailed Description | Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 10 patients with macular edema associated with retinal vein occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25). |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Dexamethasone drug delivery system (DDS-25)
350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline |
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| Study Arm (s) | Experimental: DDS-25
Intravitreal injection of DDS-25(Dexamethasone drug delivery system )
Intervention: Device: Dexamethasone drug delivery system (DDS-25) |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | July 2013 | ||||||||
| Estimated Primary Completion Date | December 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 | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01662518 | ||||||||
| Other Study ID Numbers ICMJE | Bramets-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Rubens Camargo Siqueira, Centro de Pesquisa Rubens Siqueira | ||||||||
| Study Sponsor ICMJE | Centro de Pesquisa Rubens Siqueira | ||||||||
| Collaborators ICMJE | University of Sao Paulo | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centro de Pesquisa Rubens Siqueira | ||||||||
| Verification Date | August 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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