Evaluation of safety and efficacy of intavitreal injection of recombinant Tissue Plasminogen Activator before vitrectomy for diabetic Tractional Retinal Detachment on facility and outcome of surgery
Evaluation of recombinant Tissue Plasminogen Activator efficacy on facility of vitrectomy for diabetic Tractional Retinal Detachment
Design
A randomized, blinded, sham controlled clinical trial with a parallel group design of 38 patients
Settings and conduct
In this prospective, double blinded randomized control trial, subjects with diabetic tractional retinal detachment who are candidate for vitrectomy will be enrolled in Rasoul Akram hospital. The subjects will be randomized into 50 micrograms/0.1 ml intravitreal tissue plasminogen activiator inhibitor and intravitreal bevacizumab or sham injection and intravitreal bevacizumab, 5 to 9 days prior to surgery. anatomical success rate will be evaluated 3 months after surgery in both groups.
Participants/Inclusion and exclusion criteria
Subjects with diabetic tractional retinal detachment who are candidates for vitrectomy will be enrolled
Intervention groups
Intervention group: 19 eyes of 19 patients will receive intravitreal injections of bevacizumab (2.5 mg/0.1cc) and recombinant tPA (50 µg/0.1cc) at one session, 5-9 days prior to vitrectomy.
Control group: 19 eyes of 19 patients will receive intravitreal injection of bevacizumab (2.5 mg/0.1cc) and sham injection at one session, 5-9 days prior to vitrectomy
Main outcome variables
Post surgical anatomical success rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046522N1
Registration date:2020-06-18, 1399/03/29
Registration timing:registered_while_recruiting
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Khalil Ghasemi Falavarjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 8811
Email address
ghasemifalavarjani.k@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of intavitreal injection of recombinant Tissue Plasminogen Activator before vitrectomy for diabetic Tractional Retinal Detachment on facility and outcome of surgery
Public title
Evaluation of efficacy of recombinant Tissue Plasminogen Activator on facility of vitrectomy for diabetic Tractional Retinal Detachment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic Tractional Retinal Detachment
Candidated for vitrectomy
Exclusion criteria:
combined tractional-rhegmatogenous retinal detachment
significant media opacity
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization using random numeric table
Blinding (investigator's opinion)
Double blinded
Blinding description
Simple randomization using random numeric table
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-12-04, 1398/09/13
Ethics committee reference number
IR.IUMS.FMD.REC.1398.386
Health conditions studied
1
Description of health condition studied
Diabetic Tractional Retinal Detachment
ICD-10 code
E11.3522
ICD-10 code description
Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula
Primary outcomes
1
Description
anatomical success rate
Timepoint
before surgery, one month and three months after surgery
Method of measurement
clinical examination
Secondary outcomes
1
Description
surgical facility
Timepoint
conclusion of surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: 19 eyes of 19 patients received intravitreal injections of bevacizumab (2.5 mg/0.1cc) and recombinant tPA (50 µg/0.1cc) at one session, 5-9 days before vitrectomy
Category
Treatment - Drugs
2
Description
Control group: 19 eyes of 19 patients received intravitreal injection of bevacizumab (2.5 mg/0.1cc) and sham injection at one session, 5-9 days before vitrectomy