Age Related Macular Degeneration Clinical Trial
— KIA-ProRetOfficial 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
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 2010 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Romania | Railway Universitary Hospital | Iasi |
Lead Sponsor | Collaborator |
---|---|
Ophthalmological Association Edelweiss | University of Cologne |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Growth Factors and Other Cytokines Measurements | 1 month interval | No |
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