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To assess the efficacy of sub-conjunctival Bevacizumab (Avastin) injection in treatment of primary fleshy pterygium (based on TAN grading) in patients with bilateral primary fleshy pterygium in comparison with sham injection

Protocol summary

Summary
Objective: To assess the efficacy and role of sub-conjunctival Bevacizumab injection in treatment of primary fleshy pterygium. Design: The study population: Patients with bilateral primary fleshy pterygium. Sample size: Forty eyes of twenty patients. Inclusion criteria: Patients with 20 to 70 years old, with primary bilateral fleshy pterygium invading between 1 to 4 mm into the cornea . Exclusion criteria: Any evidence of cancer or other ocular diseases except refraction errors (including anterior segment and posterior segment), diabetic patients and pregnancy. Setting and conduct: A complete eye evaluation will be performed for each patient. This includes visual-acuity determination, applanation tonometry, slit lamp examination, keratometry, and anterior segment photography. Some clinical symptoms (tingling, itching, redness, epiphora) will be noted.Avastin will be injected in subconjunctival area of pterygium body. Patients will be followed up after a week, one month, three months and six months. A complete ophthalmologic evaluation will be performed for each follow-up. Any complications will be noted. Anterior segment photography will be done for every follow-up. Interventions: Using a 1-ml syringe with 30-gauge needle, 2.5 mg (0.1 ml) of bevacizumab will be injected to the subconjunctival area of pterygium body. Sham injection will be done for the other eye of the same patient (control group). Main outcome measures: TAN grading, mean pterygium size, mean surface area of pterygium, hyperemia, photophobia, keratometry, best corrected visual acuity and clinical symptoms(tingling,itching,redness,epiphora).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014092819319N1
Registration date: 2015-01-24, 1393/11/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-24, 1393/11/04
Registrant information
Name
Alireza Haghi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2473
Email address
alireza_haghi1389@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Science
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To assess the efficacy of sub-conjunctival Bevacizumab (Avastin) injection in treatment of primary fleshy pterygium (based on TAN grading) in patients with bilateral primary fleshy pterygium in comparison with sham injection
Public title
To assess the efficacy of Avastin injection in treatment of pterygium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with 20 to 70 years old, with primary bilateral fleshy pterygium invading between 1 to 4 mm into the cornea. Exclusion criteria: Any evidence of cancer or other ocular diseases except refraction errors (including anterior segment and posterior segment), diabetic patients and pregnancy.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Double-blind trial (neither participants nor researchers)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
No. 21, Damascus Street, Palestine Avenue, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2013-07-20, 1392/04/29
Ethics committee reference number
130/762/د/92

Health conditions studied

1

Description of health condition studied
pterygium
ICD-10 code
H11.0
ICD-10 code description
PTERYGIUM

Primary outcomes

1

Description
TAN grading
Timepoint
After one month, three months and six months .
Method of measurement
based on the visibility of the underlying episcleral blood vessels in slit-lamp examination (questionnaire)

2

Description
mean pterygium size
Timepoint
After one month, three months and six months.
Method of measurement
Millimeter(By slit-lamp)

3

Description
photophobia
Timepoint
After one month, three months and six months.
Method of measurement
Questionnaire

4

Description
mean surface area of pterygium
Timepoint
After one month, three months and six months.
Method of measurement
Square millimeters(By slit-lamp)

5

Description
Hyperemia
Timepoint
After one month, three months and six months.
Method of measurement
Questionnaire

6

Description
keratometry
Timepoint
After one month and six months.
Method of measurement
By keratometer device

7

Description
Best corrected visual acuity
Timepoint
After one month, three months and six months.
Method of measurement
Snellen -E-chart

8

Description
Clinical symptoms (tingling, itching, redness, epiphora)
Timepoint
After one week, one month, three months and six months.
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Complications for example;infection and hemorrhage
Timepoint
After one week, one month, three months and six months.
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention 1: Using a 1-ml syringe with 30-gauge needle, 2.5 mg (0.1 ml) of bevacizumab will be injected to the subconjunctival area of pterygium body only once.
Category
Treatment - Drugs

2

Description
The intervention No. 2: Sham injection will be done for the other eye of the same patient only once.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat-E-Rasoul Hospital
Full name of responsible person
Alireza Haghi
Street address
1th Floor, Department of Ophthalmolgy, Hazrat-E-Rasoul Hospital, Niayesh St., Sattarkahn Ave.
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Science
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
7th Floor, Department of Internal Medicine, Hazrat-E-Rasoul Hospital, Niayesh St., Sattarkahn Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Science
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
Iran University of Medical Science
Full name of responsible person
Alireza Haghi
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Crossroad of Shahid Hemmat and Shahid Chamran Express ways
City
Tehran
Postal code
Phone
+98 21 6435 2473
Fax
+98 21 6435 2473
Email
Alireza_Haghi1389@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Mohammad Jafar Ghaempanah
Position
Assistant Professor of Ophthalmology
Other areas of specialty/work
Street address
Crossroad of Shahid Hemmat and Shahid Chamran Express ways
City
Tehran
Postal code
Phone
+98 21 6435 2473
Fax
+98 21 6435 2473
Email
Alireza_Haghi1389@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Alireza Haghi
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Crossroad of Shahid Hemmat and Shahid Chamran Express ways
City
Tehran
Postal code
Phone
+98 21 6435 2473
Fax
+98 21 6435 2473
Email
Alireza_Haghi1389@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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