Comparison of the effect of sub-conjunctival Bevacizumab and Mitomycin on intra-ocular pressure after Ahmed glaucoma Valve (AGV) implantation and determination of complete and relative success in each group
Design
Double blind clinical trial with parallel groups, phase 3 on 54 patients
Settings and conduct
In this study, which will be performed in Rasool Akram Hospital, 29 eyes of 29 patients in each group are entered. Patients with uncontrolled glaucoma with full medications or intolerant to medications who candidates for shunt will enter the study. Patients will divide into two groups by block randomization: half of them will receive sub-conjunctival bevacizumab and the other half Mitomycin . This is a randomized double-blind study in which neither the patients nor examiner are informed of the drug groups.
Participants/Inclusion and exclusion criteria
Uncontrollable glaucoma patients with full medications who are candidated for shunt implantation will enter the study.
Patients will be excluded from the study by the following criteria:
• Age under 18 years
• Secondary neovascular glaucoma due to tumor or uveitis
• Follow-up less than 6 months
• Previous shunt devices
pregnant patients
Intervention groups
Patients will be randomly divided into two categories: patients with AGV that receive subconjunctival bevacizumab injection at the end of surgery adjacent to plate, and patients who receive sub-conjunctival mytomicin .
Main outcome variables
Duration of glaucoma
Past medical history
Past surgical history
Bevcizumab or Mitomycin C injected during surgery
Type of glaucoma
Preoperative intraocular pressure, one day, one week, one month, three months and 6 months after surgery
Number of preoperative drugs
Number of drugs after surgery (last follow-up)
Complications of surgery in two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210521051355N1
Registration date:2021-09-28, 1400/07/06
Registration timing:registered_while_recruiting
Last update:2021-09-28, 1400/07/06
Update count:0
Registration date
2021-09-28, 1400/07/06
Registrant information
Name
Kiandokht Ghamari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 6185
Email address
kian2_gh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-08, 1400/06/17
Expected recruitment end date
2024-09-07, 1403/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the effect of subconjunctival injection of Bevacizumab and Mitomycin in outcome of Ahmed Glaucoma Valve (AGV) implantation
Public title
Comparision of the effect of subconjunctival injection of Bevacizumab and Mitomycin in outcome of Ahmed Glaucoma Valve (AGV)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Uncontrolled glaucoma with full medications
First shunt candidate patients
Exclusion criteria:
Under 18 years old patients
Secondary neovascular glaucoma due to tumor or uveitis
Under 6 month follow up
Previous shunts
pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization is performed to make the number of patients one at last. In this way, the four blocks will be determined as permutations A and B.
To reach the sample size 29 people in each group need to run 7 blocks. Finally, the last two will be randomly assigned to two groups.
There are generally six possible permutations for sequences A and B. Write all possible sequences and assign them the numbers 1 to 6. Then we randomly (randomly) select one of the possible sequences each time. Sampling of these 6 sequences may be done by placement so that it is not possible to predict the next selected sequences.
Permutations:
1, A A B B
2, A B A B
3, A B B A
4, B B A A
5, B A B A
6, B A A B
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study, in which patients and the examiner don't know about the type of the drug used for sub-conjunctival injection.Only the main researcher is aware of type of medications.
This procedure is utilized to prevent bias in research results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Iran University of Medical sciences
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-06-29, 1400/04/08
Ethics committee reference number
IR.IUMS.REC.1400.314
Health conditions studied
1
Description of health condition studied
uncontrolled glaucoma
ICD-10 code
H40.50X3
ICD-10 code description
Glaucoma secondary to other eye disorders, unspecified eye, severe stage
Primary outcomes
1
Description
IOP changes after Ahmed valve implantation with sub-conjunctival injection of bevacizumab or mitomycin
Timepoint
IOP measurement before surgery, 1, 7, 30 days and 3, at least 6 month after surgery and in the last follow up after surgery
Method of measurement
Goldman tonometer
Secondary outcomes
1
Description
number of glaucoma medication after surgery
Timepoint
Baseline,first day,one week,first month,three months,6 months and last follow up
Method of measurement
counting the number of antiglaucoma drugs
2
Description
complications in each group
Timepoint
first day,First week,first month,three months,6months after surgery
Method of measurement
qualitative and descriptive
Intervention groups
1
Description
To insert the Ahmed Glaucoma Valve (AGV),peritomy will performed by conjunctival incision at 4 mm from the limbus in the superotemporal quadrant. Ahmed valve will prime with balanced salt solution and fix with 8-0 nylon into sclera. Ahmed valve tube will insert from 2 mm of the limbus into anterior chamber.The tube is then sutured to the sclera with 10-0 nylon suture. An scleral patch graft by 10-0 nylon on the tube and conjunctiva and tenon will suture continuously with 8‐0 vicryl suture. Patients will randomly receive subconjunctival injection of 0.1 ml of Bevacizumab (25 mg/ml) from Behestan Darou or 0.1ml of Mitomycin %0.2mg from Kyowa Japan company adjacent to Ahmed valve plate.
Category
Treatment - Drugs
2
Description
Control To insert the Ahmed Glaucoma Valve (AGV),peritomy will performed by conjunctival incision at 4 mm from the limbus in the superotemporal quadrant. Ahmed valve will prime with balanced salt solution and fix with 8-0 nylon into sclera. Ahmed valve tube will insert from 2 mm of the limbus into anterior chamber.The tube is then sutured to the sclera with 10-0 nylon suture. An scleral patch graft by 10-0 nylon on the tube and conjunctiva and tenon will suture continuously with 8‐0 vicryl suture. Patients will randomly receive subconjunctival injection of 0.1 ml of Mitomycin %0.2mg from Kyowa Japan company adjacent to Ahmed valve plate.: