Intravitreal Avastin in Proliferative Retinopathies

NCT ID: NCT00564148

Last Updated: 2011-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Retinal Neovascularization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A,1, II

Group Type EXPERIMENTAL

Avastin

Intervention Type DRUG

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

Interventions

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Avastin

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

Intervention Type DRUG

Other Intervention Names

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Bevacizumab

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ophthalmological Association Edelweiss

OTHER

Sponsor Role lead

Responsible Party

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Ophthalmological Association Edelweiss

Principal Investigators

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NARCISA IANOPOL, researcher

Role: PRINCIPAL_INVESTIGATOR

Ophthalmological Association Edelweiss

Locations

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Ochiul Diabetic

Iași, , Romania

Site Status

Countries

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Romania

Other Identifiers

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SITE-App

Identifier Type: -

Identifier Source: secondary_id

AVAST-ro-1

Identifier Type: -

Identifier Source: org_study_id

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