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. Identifier: NCT00564148
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : July 22, 2011
Information provided by:
Ophthalmological Association Edelweiss

November 26, 2007
November 27, 2007
July 22, 2011
July 2007
November 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00564148 on Archive Site
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 ]
Same as current
Not Provided
Not Provided
Intravitreal Avastin in Proliferative Retinopathies
Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes
The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes

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.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Retinal Neovascularization
Drug: Avastin
2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
Other Name: Bevacizumab
Experimental: A,1, II
Intervention: Drug: Avastin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
NARCISA IANOPOL, Ophthalmological Association Edelweiss
Ophthalmological Association Edelweiss
Not Provided
Principal Investigator: NARCISA IANOPOL, researcher Ophthalmological Association Edelweiss
Ophthalmological Association Edelweiss
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP