Protocol summary

Summary
Enzymatic vitreolysis by plasmin injection, is the newest method of treatment, inducing posterior Vitreous detachment, by its enzymatic action, that affects on laminin and fibronectin, located between posterior vitreous, and internal limiting membrane, and releases the traction of posterior cortex, which plays a major role in the increase, and chronification of macular edema, and finally aids in edema resolution, Specially if there is some evidence of diffuse diabetic macular edema or, posterior hyaloid traction. In this study we will try to evaluate the effect of autolog plasmin injection produced by urokinase, without vitrectomy, as a primary treatment of diffuse diabetic macular edema. Inclusion criteria contain diabetic patients, which suffer from diffuse diabetic macular edema. Exclusion criteria contain uncontrolled hypertension, unstable blood sugar level, renal failure, history of ocular hypertension, glaucoma, ischemic macular or peripheral retina, history of ocular surgery in the last 6month, posterior vitreous detachment, and proliferative diabetic retinopathy. Study will be performed by one time injection of intravitreal plasmin in case group, without any intervention in control group, in totally 20 eyes with diffuse diabetic macular edema, and the effect on macular edema will evaluate by measurement of the changes in visual acuity and central macular thickness before, 1 month, and 2 month after injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050522112N1
Registration date: 2015-06-17, 1394/03/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-17, 1394/03/27
Registrant information
Name
Ali Hamidian Shoormasti
Name of organization / entity
Alzahra Eye Hospital, Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5799
Email address
drhamidian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Zahedan University of Medical Science
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravitreal autologous plasmin injection, in treatment of diffuse diabetic macular edema
Public title
Effect of intraocular plasmin injection, in diabetic macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic patients suffer from diffuse diabetic macular edema. Exclusion criteria: Uncontrolled hypertension; Unstable blood sugar level; Renal failure; History of Ocular hypertension and, Glaucoma; Ischemic macular or peripheral Retina; History of ocular surgery in last 6 month; Posterior vitreous detachment; Proliferative diabetic retinopathy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences, ethics committee
Street address
University of Medical sciences, Khalij fars Blv, Dr. Hessabi Sqhare, Zahedan, Iran
City
Zahedan
Postal code
98167-43463
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
1240

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
H35.0
ICD-10 code description
Background retinopathy and retinal vascular changes

Primary outcomes

1

Description
Central macular thickness
Timepoint
Befor intervention, 1month, and 2 month later
Method of measurement
Ocular cohrent tomography.

2

Description
Visual acuity
Timepoint
Befor intervention, 1momth, and 2month later
Method of measurement
Snelen chart

Secondary outcomes

empty

Intervention groups

1

Description
One time injection of autologous serum plasmin, 0.2 ml intravitreal
Category
Treatment - Drugs

2

Description
Without any intervention, in cotrole group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Eye Hospital, Zahedan
Full name of responsible person
Dr. Ali Hamidian Shoormasti
Street address
No15, Hashemian Alley, 3rd Neyestan Street, Pasdaran Ave, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Zahedan University of Medical Science
Full name of responsible person
Dr. Montazeri far
Street address
University of Medical Science, Khalij Fars Blvd, Dr. Hesabi Square, Zahedan, Iran
City
Zahedan
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 of Zahedan 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
Alzahra Eye Hospital, Zahedan
Full name of responsible person
Dr. Ali Hamidian Shoormasti
Position
Ophthalmology resident
Other areas of specialty/work
Street address
No15, Hashemian Alley, 3rd Neyestan Street, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2257 7263
Fax
Email
Alihamidian1@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alzahra Eye Hospital, Zahedan
Full name of responsible person
Dr. Ali Hamidian Shoormasti
Position
Ophthalmology resident
Other areas of specialty/work
Street address
No15, Hashemian Alley, 3rd Neyestan Street, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2257 7263
Fax
Email
Alihamidian1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alzahra Eye Hospital, Zahedan
Full name of responsible person
Dr. Ali Hamidian Shoormasti
Position
Ophthalmology resident
Other areas of specialty/work
Street address
No15, Hashemian Alley, 3rd Neyestan Street, Pasdaran Ave , Tehran
City
Tehran
Postal code
Phone
+98 21 2257 7263
Fax
Email
Alihamidian1@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
empty
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