Objective:The effect of intravitreal injection of Avastin in patients with age-related macular degeneration neovascular، Methods:Randomized, single blind, no placebo
Inclusion criteria: Age over 65 years, no history of previous treatment, angiographic evidence of leakage or macular thickness by OCT, a new sub-retinal hemorrhage with loss of visual acuity.Sample size: 76، Intervention:Avastin 1 / 25mg at 0.05 liquid Injection، Second and third injections were repeated one month after the first injection. Medication Intervention time:tir 90 till khordad 93. Outcomes of the study: Improve visual acuity in patients with macular degeneration related to age neovascular every week for a month, then three and six months after the intervention was evaluated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070218323N1
Registration date:2014-08-24, 1393/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-24, 1393/06/02
Registrant information
Name
Abas Ataei Kachoei
Name of organization / entity
Birjand University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5256 2403
Email address
abas_ataei@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2014-06-15, 1393/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravitreal injection of Avastin in patients with age-related macular degeneration
Public title
The effects of َAvastin in patients with age-related macular degeneration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : age ≥ 65 years, no history of previous treatment, angiographic evidence of leakage or macular thickness by OCT, new subretinal hemorrhage was associated with decreased visual acuity.
exclusion criteria : history of glucoma treatment surgery , history of ocular inflammation , history of thrombo-embolic diseases.
Age
From 65 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Postal code
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
1392-09-20
Health conditions studied
1
Description of health condition studied
age-related macular degeneration
ICD-10 code
H53,H54
ICD-10 code description
Visual disturbances and blindness
Primary outcomes
1
Description
Visual acuity
Timepoint
Baseline،One month after the intervention،three month after the intervention، six month after the intervention
Method of measurement
Snellen chart
Secondary outcomes
1
Description
Myocardial infarction, stroke and venous thromboembolism, hemorrhage, inflammation of the eye, uveitis, endophthalmitis, glaucoma, retinal detachment, premature cataract
Timepoint
Baseline, one month after the intervention, three months after the intervention, six months after the intervention.
Method of measurement
Doctor - EKG - slit lamp examination - an examination with the ophthalmoscope
Intervention groups
1
Description
Avastin 1 / 25mg at 0.05 liquid Injection، Second and third injections were repeated one month after the first injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
valiasr hospital
Full name of responsible person
Drgholamhosein yaghobi،Professor of Ophthalmologyand retine feloshib
Street address
South Khorasan, Birjand،ghafari street،valiasr hospital، Department of Ophthalmology
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ms. Kobra sarchahi-Research
Street address
Birjand University of Medical Sciences-Third Floor-Vice President of Education and Research Building
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
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
valiasr hospital
Full name of responsible person
Ataei kachoei abas
Position
Medical Student،intern
Other areas of specialty/work
Street address
Ghaffari street،Birjand University of Medical Sciences،School of Medicine
City
Birjand
Postal code
Phone
+98 56 1444 3041
Fax
Email
sinaalipour81@gmail.com- abas_ataei@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
valiasr hospital
Full name of responsible person
Dr.gholamhosein yaghobi
Position
Ophthalmologist،retine feloshib
Other areas of specialty/work
Street address
ghaffari street-valiasr hospital
City
Birjand
Postal code
Phone
00
Fax
Email
yaqubig@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ataei kachoei abas
Position
Medical Student،intern
Other areas of specialty/work
Street address
City
Birjand
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)