Diabetic RetinopathyPhase 1/2NCT00849537
The Effect of Intravitral Injection of Triamcinolone Combined With Cataract Surgery (Phacoemulsification) on Diabetic Macular Edema and Diabetic Retinopathy
A Phase 1/2 study testing Triamcinolone in people with Diabetic Retinopathy, run by Shahid Beheshti University of Medical Sciences at 3 sites in Iran.
Trial summary
In this study, regressed proliferative diabetic retinopathy, very severe, severe and moderate non-prolifrative diabetic retinopathy patients who were going to have a cataract surgery, underwent a complete eye examination, OCT, FAG and color photography 2 weeks prior to their operation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 3 sitesIran
- Study dates
- Apr 2008to Apr 2009
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetic patients with non-proliferative diabetic retinopathy and regressed PDR
Who cannot join
- Uncontrolled HTN
- History of glaucoma
- Active PDR
- NVI
- TRD
- Any ophthalmic operation
Show all 9Show fewer
- Renal problem(cr>3)
- CVA
- Uveitis
Trial locations and contacts
3 sites in 1 country.
Iran3 sites, 1 recruiting
- Active, not recruiting
Ophthalmic Research Centre
Tehran, Tehran Province, 1666663111
- Active, not recruiting
Siamak Moradian,MD
Tehran, Tehran Province, 166666
- Recruiting
Study site
Tehran
About this study
In this study, regressed proliferative diabetic retinopathy, very severe, severe and moderate non-prolifrative diabetic retinopathy patients who were going to have a cataract surgery, underwent a complete eye examination, OCT, FAG and color photography 2 weeks prior to their operation. All patients divided in two: 1) control group (Phyco,PCIOL), 2) triamcinolone treatment group (Phaco with PCIOL+IVT). One month after surgery a complete eye examination will be done especially; IOP and endophthalmitis. A 6 month follow-up will be done for these two groups and diabetic retinopathy progression will be checked.
- Conditions
- Diabetic Retinopathy
- Being tested
- Triamcinolone
- Keywords
- Triamcinolon, Cataract, Diabetic retinopathy, non-proliferative retinopathy
- Medical subject headings
- Diabetic Retinopathy, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
Injection of intravitreal Triamcinolone
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone | Experimental | Injection of intravitreal Triamcinolone Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macula diameter
Measured: 6th week, 3, 6 months
Secondary outcomes (1)
Diabetic retinopathy
Measured: 6th weeks, 3 and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Siamak Moradian, MD, Principal investigator, Shaheed Beheshti University Of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849537
- Sponsor's protocol ID
- 8711
- Status last verified
- Feb 2009
- First submitted
- 23 Feb 2009
- Last updated
- 24 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravitral Injection of Triamcinolone Combined With Cataract Surgery (Phacoemulsification) on Diabetic Macular Edema and Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT00849537
- Acronym / sponsor ID
- 8711
- Conditions
- Diabetic Retinopathy
- Keywords
- Triamcinolon, Cataract, Diabetic retinopathy, non-proliferative retinopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 24 Feb 2009 (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.
In this study, regressed proliferative diabetic retinopathy, very severe, severe and moderate non-prolifrative diabetic retinopathy patients who were going to have a cataract surgery, underwent a complete eye examination, OCT, FAG and color photography 2 weeks prior to their operation. All patients divided in two: 1) control group (Phyco,PCIOL), 2) triamcinolone treatment group (Phaco with PCIOL+IVT). One month after surgery a complete eye examination will be done especially; IOP and endophthalmitis. A 6 month follow-up will be done for these two groups and diabetic retinopathy progression will be checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone | Experimental | Drug: TriamcinoloneInjection of intravitreal Triamcinolone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients with non-proliferative diabetic retinopathy and regressed PDR
Key exclusion criteria (9 listed)
- Uncontrolled HTN
- History of glaucoma
- Active PDR
- NVI
- TRD
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 |
|---|---|---|
| TriamcinoloneInjection of intravitreal Triamcinolone | Drug | Triamcinolone |
Primary outcome
Macula diameter
Time frame: 6th week, 3, 6 months
1 secondary outcome
Diabetic retinopathy
Time frame: 6th weeks, 3 and 6 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
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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.
Dr. Siamak Moradian, MD principal investigator
Shaheed Beheshti University Of Medical Science
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Triamcinolone in people with Diabetic Retinopathy, run by Shahid Beheshti University of Medical Sciences at 3 sites 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siamak Moradian, MD (00982122592200, Moradian33195@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macula diameter (time frame: 6th week, 3, 6 months). 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 24 Feb 2009.