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Intravitreal Avastin in Proliferative Retinopathies (SITE-App)

Primary Purpose

Retinal Neovascularization

Status
Completed
Phase
Phase 2
Locations
Romania
Study Type
Interventional
Intervention
Avastin
Sponsored by
Ophthalmological Association Edelweiss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Neovascularization focused on measuring antiVEGF therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ochiul Diabetic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A,1, II

Arm Description

Outcomes

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

Secondary Outcome Measures

The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections

Full Information

First Posted
November 26, 2007
Last Updated
July 20, 2011
Sponsor
Ophthalmological Association Edelweiss
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1. Study Identification

Unique Protocol Identification Number
NCT00564148
Brief Title
Intravitreal Avastin in Proliferative Retinopathies
Acronym
SITE-App
Official Title
Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ophthalmological Association Edelweiss

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Neovascularization
Keywords
antiVEGF therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A,1, II
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Avastin
Other Intervention Name(s)
Bevacizumab
Intervention Description
2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NARCISA IANOPOL, researcher
Organizational Affiliation
Ophthalmological Association Edelweiss
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochiul Diabetic
City
Iasi
ZIP/Postal Code
700377
Country
Romania

12. IPD Sharing Statement

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Intravitreal Avastin in Proliferative Retinopathies

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