Clincosm LogoSign in Get a demo

SITE-App: Intravitreal Avastin in Proliferative Retinopathies

Sponsor
Ophthalmological Association Edelweiss (Other)
Overall Status
Completed
CT.gov ID
NCT00564148
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
29
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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
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
Anticipated 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 :
Jul 1, 2007
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Dec 1, 2009

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 Names:
  • 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 [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 [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ochiul Diabetic Iasi Romania 700377

    Sponsors and Collaborators

    • Ophthalmological Association Edelweiss

    Investigators

    • Principal Investigator: NARCISA IANOPOL, researcher, Ophthalmological Association Edelweiss

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00564148
    Other Study ID Numbers:
    • AVAST-ro-1
    • SITE-App
    First Posted:
    Nov 27, 2007
    Last Update Posted:
    Jul 22, 2011
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    antiVEGF therapy
    Additional relevant MeSH terms:
    Retinal Neovascularization
    Neovascularization, Pathologic
    Bevacizumab

    Study Results

    No Results Posted as of Jul 22, 2011