Intravitreal Avastin in Proliferative Retinopathies (SITE-App)

July 20, 2011 updated by: Ophthalmological Association Edelweiss

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Iasi, Romania, 700377
        • Ochiul Diabetic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A,1, II
Drug: Avastin
2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
Other Names:
  • Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthalmological Association Edelweiss

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (ESTIMATE)

November 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVAST-ro-1
  • SITE-App

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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