Intravitreal Avastin in Proliferative Retinopathies

Retinal Neovascularization Clinical Trial

— SITE-App  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564148
• Other study ID #: AVAST-ro-1
• Secondary ID: SITE-App
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2007
• Last updated: July 20, 2011
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2008
• Source: Ophthalmological Association Edelweiss
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• Retinal Neovascularization

Intervention

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

Locations

Country	Name	City	State
Romania	Ochiul Diabetic	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
Ophthalmological Association Edelweiss

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus		one year	Yes
Secondary	The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections		one year	Yes