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

November 26, 2007
July 20, 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 ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00564148 on ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
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 ]
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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT00564148
AVAST-ro-1, SITE-App
No
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