Diabetic Macular EdemaPhase 2NCT00369863
A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
A Phase 2 study testing Triamcinolone acetonide in people with Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema. Read more about this study
- Who is it for?
- Ages 44 to 79 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Triamcinolone acetonide
- How many people
- 76 participants
- Where
- 1 siteIran
- Study dates
- Jun 2002to Jun 2003
- Phase
- Phase 2
- 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 44 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically significant macular edema(CSME)
- Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation
Who cannot join
- Mono-ocular patients
- History of vitrectomy
- Glaucoma or ocular hypertension
- Significant media opacity
- Traction on the macula
Trial locations and contacts
1 site in 1 country.
About this study
To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.
Read the detailed description
Overall 80% of diabetic patients with low vision are in the nonproliferative stage and the main cause of decreased visual acuity is macular edema.
According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema (DME) is laser therapy, which may be neither effective nor curative in some patients.There are many cases which are refractory to laser treatment or not suitable candidates for it.
Corticosteroids might have a beneficial effect on DME. They have been used with different doses and routes (periocular,intravitreal,and slow released implants) for a variety of retinal diseases.
Recently, a few prospective randomized studies, concerning the effect of intravitreal triamcinolone acetonide (IVT) on DME have been published. In their two-year results, Gillies et al. concluded that IVT improved vision and reduced macular thickness in eyes with refractory diabetic macular edema. They showed that this beneficial effect persisted for up to 2 years with repeated treatment.
We also conducted a randomized placebo-controlled clinical trial to determine the safety and efficacy of IVT for intractable DME. Besides, we tried to evaluate the effect of this intervention on angiographic findings of these patients.
- Conditions
- Diabetic Macular Edema
- Being tested
- Triamcinolone acetonide
- Keywords
- Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal triamcinolone, Macular thickness
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Central macular thickness
Secondary outcomes (6)
Visual acuity
intraocular pressure
Cataract progression
Cystoid macular edema
Macular hard exudates
Macular leakage severity in FA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startJun 2002
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 76 participants
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mohammad - Hossein Dehghan, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369863
- Sponsor's protocol ID
- 8126
- Status last verified
- Feb 2007
- First submitted
- 29 Aug 2006
- Last updated
- 28 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00369863
- Acronym / sponsor ID
- 8126
- Conditions
- Diabetic Macular Edema
- Keywords
- Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal triamcinolone, Macular thickness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2002
- Study completion
- Jun 2003
- First posted
- 30 Aug 2006 (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.
To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.
Detailed description
Overall 80% of diabetic patients with low vision are in the nonproliferative stage and the main cause of decreased visual acuity is macular edema.
According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema (DME) is laser therapy, which may be neither effective nor curative in some patients.There are many cases which are refractory to laser treatment or not suitable candidates for it.
Corticosteroids might have a beneficial effect on DME. They have been used with different doses and routes (periocular,intravitreal,and slow released implants) for a variety of retinal diseases.
Recently, a few prospective randomized studies, concerning the effect of intravitreal triamcinolone acetonide (IVT) on DME have been published. In their two-year results, Gillies et al. concluded that IVT improved vision and reduced macular thickness in eyes with refractory diabetic macular edema. They showed that this beneficial effect persisted for up to 2 years with repeated treatment.
We also conducted a randomized placebo-controlled clinical trial to determine the safety and efficacy of IVT for intractable DME. Besides, we tried to evaluate the effect of this intervention on angiographic findings of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 44 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically significant macular edema(CSME)
- Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation
Key exclusion criteria (5 listed)
- Mono-ocular patients
- History of vitrectomy
- Glaucoma or ocular hypertension
- Significant media opacity
- Traction on the macula
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 |
|---|---|---|
| Triamcinolone acetonide | Drug | – |
Primary outcome
Central macular thickness
6 secondary outcomes
Visual acuity
intraocular pressure
Cataract progression
Cystoid macular edema
Macular hard exudates
Macular leakage severity in FA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2007.
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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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.
Mohammad - Hossein Dehghan, MD principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triamcinolone acetonide in people with Diabetic Macular Edema, run by Shahid Beheshti 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 28 Feb 2007. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Central macular thickness. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2007.