This study aims to evaluate the outcome and prognostic factors of the intravitreal administration of bevacizumab monotherapy for retinopathy of prematurity (ROP), as emerged from our experience.
This is a retrospective case series that was carried out at the "Iuliu Hatieganu" University of Medicine and Pharmacy from Cluj-Napoca, Romania. It includes all the consecutive infants who received intravitreal bevacizumab monotherapy for ROP, from January 1st 2009 throughout July 31st 2013. The statistical analysis was performed with the program SPSS 20.0.0 (Chicago, Illinois, USA).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101618966N2
Registration date:2014-10-23, 1393/08/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-23, 1393/08/01
Registrant information
Name
Simona Delia Nicoara
Name of organization / entity
Iuliu Hatieganu University of Medicine
Country
Romania
Phone
0040264597256
Email address
stalu@umfcluj.ro
Recruitment status
Recruitment complete
Funding source
This study did not receive any monetary or material suppport.
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2013-07-31, 1392/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Prevention of Blindness in Retinopathy of Prematurity by Intravitreal Injection of Bevacizumab
Public title
The treatment of retinopathy of prematurity with Avastin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all the premature new borns that received intravitreal bevacizumab injections for retinopathy of prematurity
Age
From 20 days old to 3 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics Committee of the "Iuliu Hatieganu" University of Medicine and Pharmacy
Street address
8, V. Babes str.
City
Cluj-Napoca
Postal code
400012
Approval date
2011-12-12, 1390/09/21
Ethics committee reference number
466
Health conditions studied
1
Description of health condition studied
Retinopathy of prematurity
ICD-10 code
H35.1
ICD-10 code description
Retinopathy of prematurity
Primary outcomes
1
Description
regression of retinopathy of prematurity
Timepoint
one week after the intravitreal injection of bevacizumab
Method of measurement
indirect ophthalmoscopy
Secondary outcomes
1
Description
condition of the retina
Timepoint
52 weeks after the intravitreal injection of bevacizumab weeks
Method of measurement
indirect ophthalmocsopy
Intervention groups
1
Description
A dose of bevacizumab of 0.625 mg in 0.025 ml was injected in each eye from the study sample, according to the following protocol: The pupils were dilated with a mixture of tropicamide 0.5% and phenylephrine 0.5%. Anesthesia was achieved with 0.5% proparacaine hydrochloride administered topically, 3 times, every 2 minutes before the injection. Every eye was prepared in a sterile manner using 5% povidone iodine which was also instilled in the eye 3 minutes prior the injection. A nurse hold the infant's head during the procedure and 0.025 ml of bevacizumab (0.625 mg) were injected in pars plicata, 1.5 - 1.75 mm away from the limbus, with a 30 G needle, perpendicularly on the globe initially and then slightly directed toward the center of the eyeball. After the injection, the patients received topical tobramycin, 5 times/day, for 3 days. The patients were re-examined the next day and then every week to monitor the regression of the disease. The follow-up continued for 52 weeks, every 1 or 2 weeks until full vascularization of the retina was observed. Full vascularization was defined as follows: vascularization as far as it would develop without an active component or clinically significant tractional elements. All the treatments were carried out by the same physician and the examinations were performed by three ophthalmologists experienced in ROP.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
"Iuliu Hatieganu" University of Medicine and Pharmacy
Full name of responsible person
Nicoara Simona
Street address
8, V. Babes str
City
Cluj-Napoca
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
No sponsor
Full name of responsible person
Not applicable
Street address
Not applicable
City
Not applicable
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
No sponsor
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
"Iuliu Hatieganu" University of Medicine and Pharmacy
Full name of responsible person
Nicoara Simona Delia
Position
Assoc. Professor
Other areas of specialty/work
Street address
8, V. Babes str.
City
Cluj-Napoca
Province
Cluj
Postal code
Phone
0040264597256
Fax
Email
simonanicoara1@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
"Iuliu Hatieganu" University of Medicine and Pharmacy
Full name of responsible person
Cristian Cristina
Position
MD
Other areas of specialty/work
Street address
8, V. Babes str.
City
Cluj-Napoca
Province
Cluj
Postal code
Phone
0040264597256
Fax
Email
christinacristian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
"Iuliu Hatieganu" University of Medicine and Pharmacy
Full name of responsible person
Nicoara Simona Delia
Position
Assoc. Prof.
Other areas of specialty/work
Street address
8, V. Babes str.
City
Cluj-Napoca
Province
Cluj
Postal code
400012
Phone
0040264597256
Fax
Email
simonanicoara1@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)