Diabetic Macular EdemaNCT01141881
Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema
A study testing Tissue Plasminogen Activator,bevacizumab ,follow up in people with Diabetic Macular Edema, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Tissue Plasminogen Activator,bevacizumab ,follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- May 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema
Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME).
- Conditions
- Diabetic Macular Edema
- Being tested
- Tissue Plasminogen Activator,bevacizumab ,follow up
- Keywords
- Tissue Plasminogen activator,, Clinically significant macular edema,, Refractory Diabetic macular edema ,, posterior vitreous detachment
- Medical subject headings
- Vitreous Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Plasminogen Activator,bevacizumab ,follow upDrug
Also called bevacizumab :avastin
25 microgram in 0.05 cc,1.25 mg in 0.05 cc,nothing
| Study group | Role | What they receive |
|---|---|---|
| TPA,IVB,F/U | Experimental | Not described Receives: Drug: Tissue Plasminogen Activator,bevacizumab ,follow up |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startMay 2009
- Primary completionJan 2010 (estimated)
- Study completionMar 2010
Why it stopped: occurrence of retinal hemorrhage , increase in macular edema of some patients in TPA group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- Single blind
- Who is masked
- Investigator
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- naser shoeibi, MD, Study director, mashhad university of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141881
- Sponsor's protocol ID
- 2202
- Status last verified
- Sep 2008
- First submitted
- 10 Jun 2010
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18040240
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01141881
- Acronym / sponsor ID
- 2202
- Conditions
- Diabetic Macular Edema
- Keywords
- Tissue Plasminogen activator,, Clinically significant macular edema,, Refractory Diabetic macular edema ,, posterior vitreous detachment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: occurrence of retinal hemorrhage , increase in macular edema of some patients in TPA group
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME).
Study design
- Primary purpose
- Treatment
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPA,IVB,F/U | Experimental | Drug: Tissue Plasminogen Activator,bevacizumab ,follow up |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Plasminogen Activator,bevacizumab ,follow upAlso: bevacizumab :avastin25 microgram in 0.05 cc,1.25 mg in 0.05 cc,nothing | Drug | TPA,IVB,F/U |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: occurrence of retinal hemorrhage , increase in macular edema of some patients in TPA group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2010.
- Background: PubMed 18040240Murakami 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
naser shoeibi, MD study director
mashhad university of medical science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Plasminogen Activator,bevacizumab ,follow up in people with Diabetic Macular Edema, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: occurrence of retinal hemorrhage , increase in macular edema of some patients in TPA group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01141881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2010.