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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ophthalmological Association Edelweiss
• Collaborator: University of Cologne
• Treatments: Bevacizumab; Mitogens

Criteria

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