Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab (KIA-ProRet)
Aims of the trial: Establishing the profile of the growth factors and other mediators of angiogenesis in different ocular fluids (aqueous humour, vitreous gel and ocular liquid in vitrectomized eyes), in the 2 most frequent proliferative retinopathies - diabetic proliferative retinopathy (PDR) and exudative age related macular degeneration (AMD). Following up the dynamic of this profile before and after intravitreal administration of Bevacizumab (Avastin) as an anti-VEGF blocker.
Materials: The research will be conducted on the following categories of patients groups:
- nondiabetic patients without AMD or any other diagnosed proliferative ocular disease (controls)
- patients with age related macular degeneration (AMD groups) before and after intravitreal injections with Avastin
- diabetic patients with different types of diabetic retinopathy, before and after intravitreal Avastin (diabetic groups) Methods: Samples from different ocular fluids will be collected from each group of patients. 10 growth factors and other 10 cytokines will be determined in the ocular fluids samples.
Results: The results from the biochemical measurements will be statistically interpreted in order to obtain conclusions for the clinical practice.
Conclusions: The conclusions of this trial will be used exclusively for research publications and communications, as well as for clinical practice.
|Proliferative Diabetic Retinopathy Age Related Macular Degeneration||Drug: Avastin intravitreal injection||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Profile of the Growth Factors and Other Mediators of Angiogenesis in the Ocular Fluids in Proliferative Retinopathies (AMD and PDR) Before and After the Intravitreal Administration of Bevacizumab (Avastin) as an Anti-VEGF Blocker|
- Growth Factors and Other Cytokines Measurements [ Time Frame: 1 month interval ]
|Study Start Date:||October 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Drug: Avastin intravitreal injection
1,25 mg of Bevacizumab (Avastin) will be intravitreally injected 4 weeks interval in the proliferative retinopathies groups (exudative age related macular degeneration and proliferative diabetic retinopathy)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776763
|Railway Universitary Hospital|
|Iasi, Romania, 700506|
|Principal Investigator:||NARCISA IANOPOL, Researcher||Railway Universitary Hospital|