Eligible patients are submmitted to a complete ophthalmological examination. Fluorescein angiogram and Optical Coherence Tomograpy (OCT) will be performed at predetermined frequency. Patients will be submitted to intravitreal injections of 1.25 mg of bevacizumab every five weeks until OCT central macular thickness is bellow 250 microns up to a limit of 6 consecutive injections. After normalization of CMT, patients will be submitted to a single session of argon green laser. Follow-up will be performed at a 5-week interval.
Main purpose is visual acuity and OCT changes. Improvement is defined as VA gain of 2 or more lines of ETDRS letters. VA worsening is defined as VA drop of 2 or more ETDRS lines.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011295270N1
Registration date:2010-12-01, 1389/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-01, 1389/09/10
Registrant information
Name
Arnaldo Bordon
Name of organization / entity
Banco de Olhos de Sorocaba
Country
Brazil
Phone
0055112127000
Email address
afbordon@terra.com.br
Recruitment status
Recruitment complete
Funding source
Self funding by the Banco de Olhos de Sorocaba (Sorocaba Eye Bank Hospital)
Expected recruitment start date
2010-10-01, 1389/07/09
Expected recruitment end date
2011-06-01, 1390/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of macular edema secondary to central vein occlusion
Public title
Treatment of macular edema secondary to central vein occlusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion crieria: Visual acuity equal or worse than 20/40 and equal or greater than 20/400; Minimum OCT central thickness of 250 microns
Onset of central vein occlusion between three and 12 months.
Visual acuity better than 20/40 on the other eye
Exclusion criteria: neovascularization of the retina, optic disk, iris or angle.
Uncontrolled glaucoma
Intraocular surgery and/or injection of any medication in the past 3 months
Age
From 50 years old to 100 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
VEIN OCCLUSION STUDY
Secondary trial Id
035/2010
Registration date
2010-05-08, 1389/02/18
Ethics committees
1
Ethics committee
Name of ethics committee
Hospital Oftalmologico de Sorocaba Ethics Committee
Street address
Rua Nabeck Shiroma, 210
City
Sorocaba
Postal code
18360
Approval date
2010-08-03, 1389/05/12
Ethics committee reference number
035/2010
Health conditions studied
1
Description of health condition studied
central vein occlusion
ICD-10 code
H34.8
ICD-10 code description
Other retinal vascular occlusions
Primary outcomes
1
Description
change of visual acuity
Timepoint
6 months
Method of measurement
ETDRS chart
Secondary outcomes
1
Description
OCT (Optical Coherence Tomograpy) central macular thickness changes
Timepoint
6 months
Method of measurement
Stratus OCT
Intervention groups
1
Description
Intravitreal injections of 1.25 mg of bevacizumab every five weeks until OCT central macular thickness is bellow 250 microns up to a limit of 6 consecutive injections. After normalization of CMT, patients will be submitted to a single session of argon green laser; No control
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Oftalmologico de Sorocaba
Full name of responsible person
Suellen Fogaca
Street address
Rua Nabeck Shiroma, 210
City
Sorocaba
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Banco de Olhos de Sorocaba
Full name of responsible person
Edil Souza
Street address
Rua Nabeck Shiroma, 210
City
Sorocaba
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Banco de Olhos de Sorocaba
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hospital Oftalmologico de Sorocaba
Full name of responsible person
Janaina CR de Souza
Position
fellow of the retina service
Other areas of specialty/work
Street address
Rua Nabeck Shiroma, 210
City
Sorocaba
Province
Sao Paulo
Postal code
18360
Phone
00551132127000
Fax
Email
janamedsouza@ig.com.br
Web page address
www.bos.org.br
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hospital Oftalmologico de Sorocaba
Full name of responsible person
Arnaldo F Bordon
Position
Head of the Retina and Vitreous Sector
Other areas of specialty/work
Street address
Rua Nabeck Shiroma, 210
City
Sorocaba
Province
Sao Paulo
Postal code
18360
Phone
00551532127000
Fax
00551131154344
Email
afbordon@terra.com.br
Web page address
www.bos.org.br
Person responsible for updating data
Contact
Name of organization / entity
Hospital Oftalmologico de Sorocaba
Full name of responsible person
Arnaldo F Bordon
Position
Head of the Retina and Vitreous Sector
Other areas of specialty/work
Street address
Rua Nabeck Shiroma, 210
City
Sorocaba
Province
Sao Paulo
Postal code
18360
Phone
00551132127000
Fax
00551131154344
Email
afbordon@terra.com.br
Web page address
www.bos.org.br
Sharing plan
Deidentified Individual Participant Data Set (IPD)