Age Related Macular Degeneration, Proliferative Diabetic Retinopathy
Conditions
Brief summary
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.
Interventions
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)
Sponsors
University of Cologne
Ophthalmological Association Edelweiss
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth Factors and Other Cytokines Measurements | 1 month interval |
Countries
Romania
Outcome results
None listed