Evaluation of the Role of Intravitreal Tissue Plasminogen... | NCT01141881

Studies
Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema

NCT01141881

Sponsor

Mashhad University of Medical Sciences

Status

Terminated

Last Update Posted

Oct 8, 2010Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Diabetic Macular Edema

Interventions

Tissue Plasminogen Activator,bevacizumab ,follow up

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

occurrence of retinal hemorrhage , increase in macular edema of some patients in TPA group

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Mar 2010Actual

First Submitted Date

Jun 10, 2010

First Submission Date that Met QC Criteria

Jun 10, 2010

First Posted Date

Jun 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2010

Last Update Posted Date

Oct 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TPA,IVB,F/U	Experimental		Drug: Tissue Plasminogen Activator,bevacizumab ,follow up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tissue Plasminogen Activator,bevacizumab ,follow up	Drug	25 microgram in 0.05 cc,1.25 mg in 0.05 cc,nothing	TPA,IVB,F/U

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 2 diabetes
Non proliferative diabetic retinopathy(NPDR) stage of diabetic retinopathy
patients with refractory DME CSME (patients with the last MPC at least 3 months before and no improvement was observed in BCVA, macular thickness inOCT, clinical examination and fundus photographs of patients )
Absence of PVD in the B-scan
Absence of PVD in OCT of macular area and optic disk
Absence of PVD in slit lamp biomicroscopy(SLE)
the last PRP session was at least 3 months ago.
Absence of traction on macula in clinical examination and OCT

Exclusion Criteria:

One eye patients
Patients who are candidates for intraocular surgery.
Patients with the history of glaucoma or ocular hypertension
Patients with a history of vitrectomy in the study eye
Not being able to refer for the next visits
Eyes with cataract that makes the assessment of the macula impossible.
Intraretinal hemorrhage at fovea that will interfere with OCT.
BCVA ≤ 0.1

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
naser shoeibi, MD	mashhad university of medical science	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Khatam Hospital		Mashhad	Razavi Khorasan Province		Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18040240	Background	Murakami T, Takagi H, Ohashi H, Kita M, Nishiwaki H, Miyamoto K, Watanabe D, Sakamoto A, Yamaike N, Yoshimura N. Role of posterior vitreous detachment induced by intravitreal tissue plasminogen activator in macular edema with central retinal vein occlusion. Retina. 2007 Oct;27(8):1031-7. doi: 10.1097/IAE.0b013e318074bc39.

ID	Term
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases

ID	Term
D010959	Tissue Plasminogen Activator
D000068258	Bevacizumab