Intravitreal Avastin in Proliferative Retinopathies - Full Text View

Sponsor:	Ophthalmological Association Edelweiss
Information provided by:	Ophthalmological Association Edelweiss
ClinicalTrials.gov Identifier:	NCT00564148

Purpose

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

Condition	Intervention	Phase
Retinal Neovascularization	Drug: Avastin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes

Resource links provided by NLM:

MedlinePlus related topics: Retinal Disorders

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Ophthalmological Association Edelweiss:

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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	July 2007
Study Completion Date:	December 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A,1, II	Drug: Avastin 2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively Other Name: Bevacizumab

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564148

Locations

Romania
Ochiul Diabetic
Iasi, Romania, 700377

Sponsors and Collaborators

Ophthalmological Association Edelweiss

Investigators

Principal Investigator:

NARCISA IANOPOL, researcher

Ophthalmological Association Edelweiss

More Information

No publications provided

Responsible Party:	NARCISA IANOPOL, Ophthalmological Association Edelweiss
ClinicalTrials.gov Identifier:	NCT00564148 History of Changes
Other Study ID Numbers:	AVAST-ro-1, SITE-App
Study First Received:	November 26, 2007
Last Updated:	July 20, 2011
Health Authority:	Romania: Ministry of Public Health

Keywords provided by Ophthalmological Association Edelweiss:

antiVEGF therapy

Additional relevant MeSH terms:

Neovascularization, Pathologic
Retinal Diseases
Retinal Neovascularization
Metaplasia
Pathologic Processes
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors

Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012