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Completed

NCT Number: NCT00564148

Intravitreal Avastin in Proliferative Retinopathies

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

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Key information

Conditions

Retinal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ochiul Diabetic

Iași, 700377, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avastin

Drug

2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively

Other names: Bevacizumab

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ophthalmological Association Edelweiss

Other

Registry information

Official study title

Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes

Acronym: SITE-App

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 27, 2007
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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