Topical Application of Latanoprost in Diabetic Retinopathy (Latano-2)
This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
University of Aarhus
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01225653
First received: October 20, 2010
Last updated: September 11, 2012
Last verified: September 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 20, 2010 | ||||||||
| Last Updated Date | September 11, 2012 | ||||||||
| Start Date ICMJE | November 2010 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The diameter of retinal arterioles [ Time Frame: 24 months ] [ Designated as safety issue: No ] The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer |
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| Original Primary Outcome Measures ICMJE |
The diameter of retinal arterioles [ Time Frame: After 24 months ] [ Designated as safety issue: No ] The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer |
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| Change History | Complete list of historical versions of study NCT01225653 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
The severity of diabetic retinopathy [ Time Frame: 24 months ] [ Designated as safety issue: No ] Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography |
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| Original Secondary Outcome Measures ICMJE |
The severity of diabetic retinopathy [ Time Frame: After 24 months ] [ Designated as safety issue: No ] Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Topical Application of Latanoprost in Diabetic Retinopathy | ||||||||
| Official Title ICMJE | Topical Application of Latanoprost in Diabetic Retinopathy | ||||||||
| Brief Summary | Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy. |
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| Detailed Description | The primary objective is to study if a sustained contraction of pathologically dilated retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany. The secondary objective is to study whether the intervention can halt the development of diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and fundus photography. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Diabetic Retinopathy | ||||||||
| Intervention ICMJE | Drug: Latanoprost
Topical application
Other Name: No other names |
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| Study Arm (s) |
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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 | 50 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 36 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01225653 | ||||||||
| Other Study ID Numbers ICMJE | Latano-2, 2010-022433-29 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of Aarhus | ||||||||
| Study Sponsor ICMJE | University of Aarhus | ||||||||
| Collaborators ICMJE | Aarhus University Hospital | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||||||
| Verification Date | September 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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