Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Proliferative Diabetic Retinopathy, Age Related Macular Degeneration

Intervention / Treatment
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* Drug: Avastin intravitreal injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 20 years nondiabetic patients requiring cataract surgery or vitrectomy for different posterior segment nonproliferative disorders - controls groups diabetic patients asking ophthalmologic treatments for different degrees of decreasing of visual acuity - diabetic groups diabetic patients requiring cataract surgery or vitrectomy - diabetic groups age related macular degeneration patients asking ophthalmologic treatments for different degrees of decreasing of visual acuity - age related macular degeneration groups age related macular degeneration patients requiring cataract surgery or vitrectomy - age related macular degeneration groups Exclusion Criteria: patients under the age of 20 years patients that did not accept and signed the informed consent of the trial patients that received any anti-VEGF therapy for any proliferative or inflammatory ocular disease patients that received any type of intraocular injection with any pharmaceutical agent patients with any clinical type of malignancy in their pathologic antecedents patients with recent penetrating trauma (less than 1 year old) patients operated for different ocular disorders requiring combination with antimetabolites (ex. 5-FU or Mitomycin C with trabeculectomy) patients with intraocular inflammations or infections or other pathologies that contraindicate open globe surgery or intraocular injections with anti-VEGF blockers

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avastin<br> | Drug: Avastin intravitreal injection<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth Factors and Other Cytokines Measurements |  | 1 month interval |