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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00776763
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : July 22, 2011
Sponsor:
Collaborator:
University of Cologne
Information provided by:
Ophthalmological Association Edelweiss

Tracking Information
First Submitted Date  ICMJE October 17, 2008
First Posted Date  ICMJE October 21, 2008
Last Update Posted Date July 22, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
Growth Factors and Other Cytokines Measurements [ Time Frame: 1 month interval ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Proliferative Diabetic Retinopathy
  • Age Related Macular Degeneration
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Avastin
Intervention: Drug: Avastin intravitreal injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 17, 2008)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776763
Other Study ID Numbers  ICMJE KIA-ProRet
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NARCISA IANOPOL, Md, PhD, Railway Universitary Hospital
Study Sponsor  ICMJE Ophthalmological Association Edelweiss
Collaborators  ICMJE University of Cologne
Investigators  ICMJE
Principal Investigator: NARCISA IANOPOL, Researcher Railway Universitary Hospital
PRS Account Ophthalmological Association Edelweiss
Verification Date October 2008

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