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

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.

Completed

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Key information

Conditions

Proliferative Diabetic Retinopathy Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Railway Universitary Hospital

Iași, 700506, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avastin Intravitreal Injection

Drug

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)

Primary outcomes

Growth Factors and Other Cytokines Measurements

Time frame: 1 month interval

Sponsors and collaborators

Lead sponsor

Ophthalmological Association Edelweiss

Other

Collaborators

University of Cologne

Registry information

Official study 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

Acronym: KIA-ProRet

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Oct 21, 2008
Registry last updated: Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed