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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Proliferative Diabetic Retinopathy
Age Related Macular Degeneration
 Drug: Avastin intravitreal injection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Ophthalmological Association Edelweiss:

Primary Outcome Measures:
  • Growth Factors and Other Cytokines Measurements [ Time Frame: 1 month interval ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin 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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776763

Locations
Romania
Railway Universitary Hospital
Iasi, Romania, 700506
Sponsors and Collaborators
Ophthalmological Association Edelweiss
University of Cologne
Investigators
Principal Investigator: NARCISA IANOPOL, Researcher Railway Universitary Hospital
  More Information

No publications provided

Responsible Party: NARCISA IANOPOL, Md, PhD, Railway Universitary Hospital
ClinicalTrials.gov Identifier: NCT00776763     History of Changes
Other Study ID Numbers: KIA-ProRet
Study First Received: October 17, 2008
Last Updated: July 20, 2011
Health Authority: Romania: Ministry of Public Health

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Retinal Degeneration
Mitogens
 Bevacizumab
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013