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Intravitreal Avastin in Proliferative Retinopathies (SITE-App)

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: NCT00564148
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes

Condition or disease Intervention/treatment Phase
Retinal Neovascularization Drug: Avastin Phase 2

Detailed Description:

Proliferative retinopathies due to different causes represent important causes for the visual acuity loss. Conventional treatments may sometimes improve the visual function, whereas other times, the visual acuity continue to decrease, in spite of all the medical, surgical or laser treatments.

Intravitreal injections with anti-VEGF agents (ex. Avastin for our trial) seem to be an important tool for certain difficult situations in which at the ocular fundus, out of different reasons (advanced age, diabetes mellitus, retinal veins occlusions, etc)new pathologic vessels appear, causing devastating changes in the posterior and anterior segment as well.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes
Study Start Date : July 2007
Primary Completion Date : November 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: A,1, II Drug: Avastin
2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
Other Name: Bevacizumab


Outcome Measures

Primary Outcome Measures :
  1. The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus [ Time Frame: one year ]

Secondary Outcome Measures :
  1. The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of a proliferative retinopathy (AGE RELATED MACULAR DEGENERATION,DIABETIC PROLIFERATIVE RETINOPATHY, etc)
  • distance acuity < 0.5
  • age > 20 years

Exclusion Criteria:

  • noncooperative patients
  • ocular infections / inflammations
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564148


Locations
Romania
Ochiul Diabetic
Iasi, Romania, 700377
Sponsors and Collaborators
Ophthalmological Association Edelweiss
Investigators
Principal Investigator: NARCISA IANOPOL, researcher Ophthalmological Association Edelweiss
More Information

Responsible Party: NARCISA IANOPOL, Ophthalmological Association Edelweiss
ClinicalTrials.gov Identifier: NCT00564148     History of Changes
Other Study ID Numbers: AVAST-ro-1
SITE-App
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: June 2008

Keywords provided by Ophthalmological Association Edelweiss:
antiVEGF therapy

Additional relevant MeSH terms:
Neovascularization, Pathologic
Retinal Neovascularization
Metaplasia
Pathologic Processes
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents