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

This study has been completed.
Sponsor:
Collaborator:
University of Cologne
Information provided by:
Ophthalmological Association Edelweiss
ClinicalTrials.gov Identifier:
NCT00776763
First received: October 17, 2008
Last updated: July 20, 2011
Last verified: October 2008

October 17, 2008
July 20, 2011
October 2008
October 2009   (final data collection date for primary outcome measure)
Growth Factors and Other Cytokines Measurements [ Time Frame: 1 month interval ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00776763 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Proliferative Diabetic Retinopathy
  • Age Related Macular Degeneration
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)
Experimental: Avastin
Intervention: Drug: Avastin intravitreal injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT00776763
KIA-ProRet
Not Provided
NARCISA IANOPOL, Md, PhD, Railway Universitary Hospital
Ophthalmological Association Edelweiss
University of Cologne
Principal Investigator: NARCISA IANOPOL, Researcher Railway Universitary Hospital
Ophthalmological Association Edelweiss
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP