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

Phase 2

Completed

• Conditions: Proliferative Diabetic Retinopathy; Age Related Macular Degeneration
• Interventions: Drug: Avastin intravitreal injection

• Registration Number: NCT00776763
• Lead Sponsor: Ophthalmological Association Edelweiss

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-10
• Study Start: 2008-10
• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-21
• Primary Completion: 2009-10
• Study Completion: 2010-12
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avastin	Avastin intravitreal injection	-

Primary Outcome Measures

Name	Time	Method
Growth Factors and Other Cytokines Measurements	1 month interval

Trial Locations

Locations (1)

Railway Universitary Hospital; 🇷🇴 Iasi, Romania