Protocol summary

Summary
Objectives: The objective of the study is to evaluate the effectiveness of Zal-trap 0.125 mg and to identify its side effects in patients resistant to Avastin. Study Design: In this quasi-experimental interventional study, the total sample volume is calculated to be 17 patients. The control group is the preoperative status of the patients and no randomization is performed. Method: In a sterile manner, 0.05 ml zal-trap is injected into the Vitreous humour of the eye with a lower visual acuity (visual acuity less than 20/100) in patients with retinal vascular disorders (AMD, DME, and RVO) who require anti-VEGF treatment and have not responded to Avastin, after obtaining informed consent. The visual acuity of the patients will be monitored in the beginning of the study and 1 week and 1 month after the procedure. Participants: The inclusion criteria are eyes with AMD or active neovascular DME, best corrected visual acuity of 20/100 (06/30) or less, capability of comprehending the advantages and risks of the study, ability to sign the informed consent form, and lack of response to Avastin treatment. The exclusion criteria of the study are the signs of ocular infection, and a positive history of MI or CVA. Interventions: After applying local anesthesia and povidone-iodine, a sterile eyelid retractor will be used. In “one” eye of the patient, 0.05 ml (1.25 mg) Zal-trap that is already prepared from a 4ml vial is injected using a 30-gauge 1cc syringe. Main outcome variables including primary and secondary outcomes are visual acuity of the patients and the height of retinal pigment epithelial detachment, respectively.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015081723651N1
Registration date: 2015-12-12, 1394/09/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-12, 1394/09/21
Registrant information
Name
Kamran Jalali
Name of organization / entity
Noor Hospital Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 82400
Email address
h.rastad@norc.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-08-27, 1394/06/05
Expected recruitment end date
2015-09-27, 1394/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of ZIV-aflibercept (Zal-trap) in patients with retinal vascular disorders resistant to Avastin
Public title
The effect of zaltrap in the treatment of retinal retinal vascular disorders resistant to Avastin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Eyes with active neovascularage-related macular degeneration (AMD) or diabetic macular edema (DME), best-corrected visual acuity of 20/100 (6/30) or less, the ability to comprehend the risks and benefits of the study, and the ability to sign the consent form; Exclusion criteria : Signs of ocular infection and a history of myocardial infarction or cerebrovascular accident.
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 17
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences (TUMS)
Street address
Keshavarz Blvd., Qods Street; Tehran, Iran
City
Tehran
Postal code
1968653111
Approval date
2015-08-10, 1394/05/19
Ethics committee reference number
IR.TUMS.REC.1394.555

Health conditions studied

1

Description of health condition studied
Retinal vascular disorders
ICD-10 code
H30-H36
ICD-10 code description
Disorders of choroid and retina

Primary outcomes

1

Description
Best corrected visual acuities
Timepoint
In the beginning of the study, and 1 day and 1 week after Zal-trap injection
Method of measurement
By the same examiner, using Snellen charts

Secondary outcomes

1

Description
The height of retinal pigment epithelium detachment
Timepoint
In the beginning of the study and 1 day and 1 week after Zal-trap injection
Method of measurement
On the horizontal scan and vertical scan passing through the foveola through averaging the horizontal and vertical measures

Intervention groups

1

Description
one intravitreal injection 0.05 ml of ziv-ablicerpt in one eye of each patient with retinal disease(AMD, CRVO) and monitor vision and OCT 1 day and 1 week after injection
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor Eye Hospital
Full name of responsible person
Dr.Kamran Jalali
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. KamranJalali
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Noor Eye Hospital
Full name of responsible person
Dr. Kamran Jalali
Position
General Ophthalmologist : Surgery of retina and vitreous and laser
Other areas of specialty/work
Street address
96, Esfandiar Blvd, Valiasr St. Tehran
City
Tehran
Postal code
1968653111
Phone
+98 21 82400
Fax
Email
h.rastad91@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Dr. Kamran Jalali
Position
General Ophthalmologist : Surgery of retina and vitreous and laserus and laser
Other areas of specialty/work
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Postal code
1968653111
Phone
+98 21 82400
Fax
+98 21 8240 1609
Email
h.rastad91@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Dr. Kamran Jalali
Position
General Ophthalmologist : Surgery of retina and vitreous and laser
Other areas of specialty/work
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Postal code
1968653111
Phone
+98 21 82400
Fax
+98 21 8240 1609
Email
h.rastad91@gmail.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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