Visual acuity and central macular thickness in the hemorrhagic choroid neo-vascularization due to age-related macular degeneration with intravitreal Avastin injection compared with intravitreal injection of tissue plasminogen activator with avastin
Our goal is to assess potential effects of improving visual acuity and macular thickness reduction using intravitreal tissue plasminogen activator with intravitreal Avastin compared to intravitreal Avastin in patients with hemorrhagic choroid neo-vascularization. Patients with clinical and laboratory hemorrhagic choroid neovascularization diagnosed due to age-related macular degeneration referring to Nikookari hospital clinics of Tabriz, Iran that require treatment with intravitreal Avastin will be selected.
Sample size: 54 eyes of patients by simple single-center randomized method assigned to two groups. Control group are receiving intravitreal Avastin standard treatment and the intervention group receiving intravitreal Avastin in addition to tissue plasminogen activator.
Visual acuity by using the Snellen chart and macular thickness by using macular OCT will be checked before treatment, one month and six months after treatment.
Inclusion criteria: recent onset of CNV due to AMD within a month. Exclusion criteria: diabetic and inflammatory maculopathy and retinal injury and clearly damage to the optic nerve.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511064166N6
Registration date:2016-03-31, 1395/01/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-31, 1395/01/12
Registrant information
Name
Rana Daei Sorkhabi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1655 1332
Email address
rana@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Visual acuity and central macular thickness in the hemorrhagic choroid neo-vascularization due to age-related macular degeneration with intravitreal Avastin injection compared with intravitreal injection of tissue plasminogen activator with avastin
Public title
Effect of intravitral injection of tissue plasminogen activator on visual acuity and retinal macular thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hemoragic CNV due to AMD; early onset of symptom in the last month; history of good visual acuity in affected eye
Exclusion criteria: history of vitroretinal surgery; uveitis with vitroretinal impairment; corneal disease for example keratoconous, dystrophy and degeneration; any medial hazeness for example vitrous hemorrhage, significant cataract ,...; pathologic myopia; diabetic retinopathy macular edema, retinal detachment, retinal vascular disorder; significant optic nerve injury
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabriz University of Medical Sciences
Street address
Tabriz - azadi avenue - golgasht street - University of Medical Sciences - Central Building No. 2 - Third floor Vice Chancellor for Research and Technology
City
tabriz
Postal code
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
TBZMED.REC.1394.1006
Health conditions studied
1
Description of health condition studied
Age related macular degeneration
ICD-10 code
H35.3
ICD-10 code description
Degeneration of macula and posterior pole
Primary outcomes
1
Description
Visual acuity
Timepoint
Before the intervention, one month and 6 months later
Method of measurement
Snellen chart
2
Description
Macular thickness
Timepoint
Prior to the study, one month and six months later
Method of measurement
Macular OCT
Secondary outcomes
empty
Intervention groups
1
Description
Intravitreal injection of 75 micrograms of tissue plasminogen activator plus 1.25 mg of Avastin in the intervention group
Category
Treatment - Drugs
2
Description
intravitreal injection of 1.25 mg Avastin in the control group (standard treatment)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikokari Eye Hospital in Tabriz
Full name of responsible person
Rahman Beyrami, ophtalmology resident
Street address
Nikokari Eye Hospital, Abbasi St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences-Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Mohamed Reza Rashidi
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences-Vice Chancellor for Research and Technology
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
Tabriz University of Medical Sciences
Full name of responsible person
Rahman Beyrami
Position
Ophtalmology resident
Other areas of specialty/work
Street address
tabriz - abbasi st. -nikokari eye hospital
City
Tabriz
Postal code
5154645395
Phone
+98 41 3657 7330
Fax
+98 41 3657 7336
Email
rahman.beyrami61@gmail.com
Web page address
http://nikukarihosp.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohamad Hussein Ahoor
Position
Ophtalmologist - vitroretinal Fellowship
Other areas of specialty/work
Street address
Nikokari eye hospital, Abbasi St.
City
Tabriz
Postal code
5154645395
Phone
+98 41 3657 7330
Fax
+98 41 3657 7336
Email
mh.ahoor@gmail.com
Web page address
http://nikukarihosp.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rahman Beyrami
Position
Ophtalmology resident
Other areas of specialty/work
Street address
Nikokari eye hospital, Abbasi St.
City
Tabriz
Postal code
5154645395
Phone
+98 41 3657 7330
Fax
+98 41 3657 7336
Email
rahman.beyram61@gmail.com
Web page address
http://nikukarihosp.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)