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Intravitreal Avastin in Proliferative Retinopathies (SITE-App)
This study is currently recruiting participants.
Verified by Ophthalmological Association Edelweiss, June 2008
Sponsored by: Ophthalmological Association Edelweiss
Information provided by: Ophthalmological Association Edelweiss
ClinicalTrials.gov Identifier: NCT00564148
  Purpose

The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes


Condition Intervention Phase
Retinal Neovascularization
Drug: Avastin
Phase II

MedlinePlus related topics: Retinal Disorders
Drug Information available for: Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title: Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes

Further study details as provided by Ophthalmological Association Edelweiss:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A,1, II: Experimental Drug: Avastin
2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564148

Contacts
Contact: NARCISA IANOPOL, researcher 0040744765927 ianisa2006@yahoo.com

Locations
Romania
Railway Universitary Hospital Recruiting
IASI, Romania, 700506
Contact: NARCISA IANOPOL, researcher     0040744765927     ianisa2006@yahoo.com    
Sponsors and Collaborators
Ophthalmological Association Edelweiss
Investigators
Principal Investigator: NARCISA IANOPOL, researcher Ophthalmological Association Edelweiss
  More Information

Responsible Party: Ophthalmological Association Edelweiss ( NARCISA IANOPOL )
Study ID Numbers: AVAST-ro-1, 1
Study First Received: November 26, 2007
Last Updated: June 9, 2008
ClinicalTrials.gov Identifier: NCT00564148  
Health Authority: Romania: Ministry of Public Health

Keywords provided by Ophthalmological Association Edelweiss:
antiVEGF therapy

Study placed in the following topic categories:
Retinal Neovascularization
Eye Diseases
Metaplasia
Bevacizumab
Neovascularization, Pathologic
Retinal Diseases

Additional relevant MeSH terms:
Pathologic Processes
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009