Comparison of success of trabeculectomy in glaucoma patients treated with trabeculectomy alone versus adjunctive intracameral bevacizumab-combined trabeculectomy: A clinical trial
Objectives: to compare the success of trabeculectomy procedure with or without intracameral bevacizumab.
Design: Primary open angle or pseudoexfoliative glaucoma patients 65 years or above who are candidates of trabeculectomy, will be randomized to either intervention (30 patients) or placebo (30 patients) group.
Settings and conduct: Primary open angle or pseudoexfoliative glaucoma patients who are candidates of trabeculectomy by a single surgeon in Farabi Hospital, Tehran, will be randomized (using random number tables) to intervention or control groups. In the postoperative follow up visits (day 1, 7 and 14 and months 1, 3 and 6) primary and secondary outcome measures will be studied.
Participants: Primary open angle or pseudoexfoliative glaucoma patients 65 years or above who are candidates of trabeculectomy (whose optic nerve function is failing on the maximum tolerated medical therapy and not likely to achieve sufficient lOP reduction with laser treatment). Exclusion criteria include patients at high risk of failure of trabeculectomy, including aphakic, pseudophakic, uveitic, neovascular and juvenile glaucoma.
Intervention: in the first group, 0.05 ml (1.25 mg) bevacizumab will be injected intracamerally at the termination of trabeculectomy. In the second group 0.05 ml placebo (balanced salt solution) will be injected.
Main outcome measure: success of tgrabeculectomy defined as intraocular pressure between 6 and 21 and 30% reduction compared to preoperative values.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012120711647N1
Registration date:2013-03-20, 1391/12/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-20, 1391/12/30
Registrant information
Name
Ghasem Fakhraie
Name of organization / entity
Glaucoma Service, Farabi Eye Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 6134
Email address
fakhraie@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-01-28, 1391/11/09
Expected recruitment end date
2013-06-30, 1392/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of success of trabeculectomy in glaucoma patients treated with trabeculectomy alone versus adjunctive intracameral bevacizumab-combined trabeculectomy: A clinical trial
Public title
The effect of bevacizumab on success of trabeculectomy in glaucoma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Primary open angle or pseudoexfoliative glaucoma patients 65 years or older who are candidates of standard trabeculectomy procedure (whose optic nerve function is failing or is likely to fail and is already on the maximum tolerated medical therapy and not likely to achieve a sufficient lOP reduction with laser treatment).
Exclusion criteria: Patients at high risk of failure of trabeculectomy, including aphakic, pseudophakic, uveitic, neovascular and juvenile glaucoma.
Age
From 18 years old to 99 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The reason for this study being double-blind is:
The investigator (the surgeon who performs trabeculectomies) is blinded, because at the end of operation he takes a syringe containing 0.05 ml of a clear liquid, but he does not know what is the liquid (either bevacizumab or balanced salt solution). The two mentioned liquids have similar appearance. However, a nurse who prepares the syringe with 0.05 ml liquid is told to fill it with either bevacizumab or balanced salt solution, and this information is recorded but not provided to the surgeon who performs trabeculectomies and the physician who visits the patients in the follow up period.
The patient is also blinded to what he/she receives. The informed consent states that they either receive placebo or the drug bevacizumab, which is chosen by random.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2013-01-13, 1391/10/24
Ethics committee reference number
91/d/130/2629
Health conditions studied
1
Description of health condition studied
Primary open-angle glaucoma
ICD-10 code
H40.1
ICD-10 code description
Glaucoma (primary)(residual stage): capsular with pseudoexfoliation of lens, chronic simple, low-tension, pigmentary
Primary outcomes
1
Description
Success of trabeculectomy
Timepoint
six months after surgery
Method of measurement
Goldmann applanation tonometry (intraocular pressure between 6 and 21 ml Hg and 30% reduction of intraocular pressure compared to preoperative values)
Secondary outcomes
1
Description
Intraocular pressure
Timepoint
Before and 1 day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery
Method of measurement
Goldmann applanation tonometry
2
Description
Corrected distance visual acuity
Timepoint
Before and 1 day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery
Method of measurement
clinical examination
3
Description
Morphology of filtration Bleb
Timepoint
one day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery
Method of measurement
Slit lamp exam; Moorfields bleb grading system and Indiana bleb appearance grading scale
4
Description
Number of medications used to lower the intraocular pressure
Timepoint
Before and 1 day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery
Method of measurement
History
5
Description
Complications of intervention including bleb leak, encapsulation and need to globe massage
Timepoint
one day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery
Method of measurement
clinical examination
6
Description
Visual field
Timepoint
Before and 6 months after surgery
Method of measurement
perimetry
7
Description
Optic nerve head appearance and cup to disc ratio
Timepoint
Before and 6 months after surgery
Method of measurement
slit lamp exam and OCT of optic nerve head
8
Description
Status of nerve fiber layer
Timepoint
Before and 6 months after surgery
Method of measurement
GDX and OCT of nerve fiber layer
Intervention groups
1
Description
Intervention 1: single injection of 1.25 mg (0.05 ml; concentration 25 mg/ml) bevacizumab (monoclonal antibody against VEGF; trade name Avastin, Genentech/Roche, San Francisco, CA) in the anterior chamber at termination of trabeculectomy surgery
Category
Treatment - Drugs
2
Description
Intervention 2: single injection of placebo (0.05 ml balanced salt solution) in the anterior chamber at termination of trabeculectomy surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
Ghasem Fakhraie
Street address
Qazvin Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Qods St., Keshavarz Blvd.
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, Tehran 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
Farabi Eye Hospital
Full name of responsible person
Hadi Ghadimi
Position
Resident of ophthalmology/MD
Other areas of specialty/work
Street address
Qazvin Sq.
City
Tehran
Postal code
Phone
+98 21 5541 8112
Fax
Email
hadi.ghadimi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghasem Fakhraie
Position
Associate professor/MD
Other areas of specialty/work
Street address
Farabi Eye Hospital, Qazvin Sq.
City
Tehran
Postal code
Phone
+98 21 5541 8112
Fax
Email
drfakhraee@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hadi Ghadimi
Position
Resident of ophthalmology/MD
Other areas of specialty/work
Street address
Farabi Eye Hospital, Qazvin Sq.
City
Tehran
Postal code
Phone
+98 21 5541 8112
Fax
Email
hadi5876@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)