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

NCT00776763 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2011-07-22

No results posted yet for this study

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.

Conditions

  • Proliferative Diabetic Retinopathy
  • Age Related Macular Degeneration

Interventions

DRUG

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)

Sponsors & Collaborators

  • University of Cologne

    collaborator OTHER

  • Ophthalmological Association Edelweiss

    lead OTHER

Principal Investigators

  • NARCISA IANOPOL, Researcher · Railway Universitary Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-10-31
Completion
2010-12-31

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00776763 on ClinicalTrials.gov