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Intravitreal Avastin in Proliferative Retinopathies (SITE-App)

This study has been completed.
Sponsor:
Information provided by:
Ophthalmological Association Edelweiss
ClinicalTrials.gov Identifier:
NCT00564148
First received: November 26, 2007
Last updated: July 20, 2011
Last verified: June 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes

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:
  • 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
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A,1, II Drug: Avastin
2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
Other Name: Bevacizumab

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:   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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: NARCISA IANOPOL, Ophthalmological Association Edelweiss
ClinicalTrials.gov Identifier: NCT00564148     History of Changes
Other Study ID Numbers: AVAST-ro-1, SITE-App
Study First Received: November 26, 2007
Last Updated: July 20, 2011
Health Authority: Romania: Ministry of Public Health

Keywords provided by Ophthalmological Association Edelweiss:
antiVEGF therapy

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

ClinicalTrials.gov processed this record on May 22, 2013