Branch Retinal Vein OcclusionPhase 2NCT00370266
Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion
A Phase 2 study testing Triamcinolone in people with Branch Retinal Vein Occlusion, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether intraocular injection of triamcinolone is effective in the treatment of macular edema in acute branch retinal vein occlusion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Branch Retinal Vein Occlusion
- What is being tested?
- Triamcinolone
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Feb 2003to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eyes suffering from branch retinal vein occlusion with less than 2 months duration.
Who cannot join
- Monocularity,
- Previous intraocular surgery or laser therapy
- Glaucoma or ocular hypertension
- Significant media opacity
- Existence of traction on the macula
- Visual acuity ≥20/40
- Signs of chronicity (such as cilioretinal and/or retinal shunt vessels)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether intraocular injection of triamcinolone is effective in the treatment of macular edema in acute branch retinal vein occlusion.
Read the detailed description
Intravitreal triamcinolone has recently been shown to have beneficial effect on chronic macular edema due to vein occlusion and preventive effect on neovascularization. Hypothetically, prevention of macular derangement by reducing the amount of edema from early phase after occlusion until restoration of collaterals seems to be helpful in these eyes. To our knowledge, no prospective randomized clinical trial, considering both macular changes and preventive effect on neovascularization has been published for intravitreal triamcinolone in acute branch retinal vein occlusion.
- Conditions
- Branch Retinal Vein Occlusion
- Being tested
- Triamcinolone
- Keywords
- Macular edema, Branch retinal vein occlusion, Intravitreal triamcinolone, Macular thickness, Retinal neovascularization
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema, Retinal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Central macular thickness
Secondary outcomes (4)
Visual acuity
Retinal neovascularization
Intraocular pressure
Cataract progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startFeb 2003
- Primary completionOct 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branch Retinal Vein OcclusionStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Alireza Ramezani, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370266
- Sponsor's protocol ID
- 8247
- Status last verified
- Jun 2008
- First submitted
- 30 Aug 2006
- Last updated
- 17 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT00370266
- Acronym / sponsor ID
- 8247
- Conditions
- Branch Retinal Vein Occlusion
- Keywords
- Macular edema, Branch retinal vein occlusion, Intravitreal triamcinolone, Macular thickness, Retinal neovascularization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 31 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.
The purpose of this study is to determine whether intraocular injection of triamcinolone is effective in the treatment of macular edema in acute branch retinal vein occlusion.
Detailed description
Intravitreal triamcinolone has recently been shown to have beneficial effect on chronic macular edema due to vein occlusion and preventive effect on neovascularization. Hypothetically, prevention of macular derangement by reducing the amount of edema from early phase after occlusion until restoration of collaterals seems to be helpful in these eyes. To our knowledge, no prospective randomized clinical trial, considering both macular changes and preventive effect on neovascularization has been published for intravitreal triamcinolone in acute branch retinal vein occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eyes suffering from branch retinal vein occlusion with less than 2 months duration.
Key exclusion criteria (7 listed)
- Monocularity,
- Previous intraocular surgery or laser therapy
- Glaucoma or ocular hypertension
- Significant media opacity
- Existence of 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 | Drug | – |
Primary outcome
Central macular thickness
4 secondary outcomes
Visual acuity
Retinal neovascularization
Intraocular pressure
Cataract progression
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 17 Jun 2008.
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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.
Alireza Ramezani, 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 in people with Branch Retinal Vein Occlusion, 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 1 inclusion and 7 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 17 Jun 2008. 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 17 Jun 2008.