Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab (KIA-ProRet)

Ophthalmological Association Edelweiss

Status and phase

Completed

Phase 2

Conditions

Age Related Macular Degeneration

Proliferative Diabetic Retinopathy

Treatments

Drug: Avastin intravitreal injection

Study type

Interventional

Funder types

Other

Identifiers

NCT00776763

KIA-ProRet

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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