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

Primary Purpose

Proliferative Diabetic Retinopathy, Age Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
Romania
Study Type
Interventional
Intervention
Avastin intravitreal injection
Sponsored by
Ophthalmological Association Edelweiss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Railway Universitary Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Avastin

Arm Description

Outcomes

Primary Outcome Measures

Growth Factors and Other Cytokines Measurements

Secondary Outcome Measures

Full Information

First Posted
October 17, 2008
Last Updated
July 20, 2011
Sponsor
Ophthalmological Association Edelweiss
Collaborators
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT00776763
Brief Title
Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab
Acronym
KIA-ProRet
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ophthalmological Association Edelweiss
Collaborators
University of Cologne

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy, Age Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avastin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Avastin intravitreal injection
Intervention Description
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)
Primary Outcome Measure Information:
Title
Growth Factors and Other Cytokines Measurements
Time Frame
1 month interval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NARCISA IANOPOL, Researcher
Organizational Affiliation
Railway Universitary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway Universitary Hospital
City
Iasi
ZIP/Postal Code
700506
Country
Romania

12. IPD Sharing Statement

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

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