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

NCT ID: NCT00776763

Last Updated: 2011-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Proliferative Diabetic Retinopathy Age Related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Avastin

Group Type EXPERIMENTAL

Avastin intravitreal injection

Intervention Type 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)

Interventions

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Avastin intravitreal injection

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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role collaborator

Ophthalmological Association Edelweiss

OTHER

Sponsor Role lead

Responsible Party

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Railway Universitary Hospital

Principal Investigators

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NARCISA IANOPOL, Researcher

Role: PRINCIPAL_INVESTIGATOR

Railway Universitary Hospital

Locations

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Railway Universitary Hospital

Iași, , Romania

Site Status

Countries

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Romania

Other Identifiers

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KIA-ProRet

Identifier Type: -

Identifier Source: org_study_id

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