Intravitreal Avastin in Proliferative Retinopathies (SITE-App)
This study has been completed.
Sponsor:
Ophthalmological Association Edelweiss
Information provided by:
Ophthalmological Association Edelweiss
ClinicalTrials.gov Identifier:
NCT00564148
First received: November 26, 2007
Last updated: July 20, 2011
Last verified: June 2008
| Tracking Information | |||||
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| First Received Date ICMJE | November 26, 2007 | ||||
| Last Updated Date | July 20, 2011 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus [ Time Frame: one year ] | ||||
| Change History | Complete list of historical versions of study NCT00564148 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections [ Time Frame: one year ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intravitreal Avastin in Proliferative Retinopathies | ||||
| Official Title ICMJE | Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes | ||||
| Brief Summary | The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes |
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| Detailed Description | Proliferative retinopathies due to different causes represent important causes for the visual acuity loss. Conventional treatments may sometimes improve the visual function, whereas other times, the visual acuity continue to decrease, in spite of all the medical, surgical or laser treatments. Intravitreal injections with anti-VEGF agents (ex. Avastin for our trial) seem to be an important tool for certain difficult situations in which at the ocular fundus, out of different reasons (advanced age, diabetes mellitus, retinal veins occlusions, etc)new pathologic vessels appear, causing devastating changes in the posterior and anterior segment as well. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Retinal Neovascularization | ||||
| Intervention ICMJE | Drug: Avastin
2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
Other Name: Bevacizumab |
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| Study Arm (s) | Experimental: A,1, II
Intervention: Drug: Avastin |
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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 | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Romania | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00564148 | ||||
| Other Study ID Numbers ICMJE | AVAST-ro-1, SITE-App | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | NARCISA IANOPOL, Ophthalmological Association Edelweiss | ||||
| Study Sponsor ICMJE | Ophthalmological Association Edelweiss | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Ophthalmological Association Edelweiss | ||||
| Verification Date | June 2008 | ||||
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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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