Branch Retinal Vein OcclusionPhase 2BRVONCT01044329
Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion
A Phase 2 study testing Bevacizumab and Triamcinolone Acetonide in people with Branch Retinal Vein Occlusion, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Branch Retinal Vein Occlusion
- What is being tested?
- Bevacizumab and Triamcinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Dec 2010
- 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
- Recent onset (less than 3 months) BRVO
Who cannot join
- Any previous intervention
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Imam Hossein medical center
Tehran
Alireza Ramezani, Assistant professor, arramezani@gmail.com
Alireza Ramezani, Assistant professor
About this study
Official title: Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion
This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.
- Conditions
- Branch Retinal Vein Occlusion
- Being tested
- Bevacizumab, Triamcinolone Acetonide
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Intravitreal, 1.25 mg, 3 times, one month apart.
Triamcinolone AcetonideDrug
Intravitreal, 2 mg, 2 times, two months apart.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal bevacizumab | Active comparator | Not described Receives: Drug: Bevacizumab |
| Intravitreal triamcinolone | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 6 months
Secondary outcomes (1)
central macular thickness
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010 (estimated)
- Study completionDec 2010 (estimated)
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
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Labbafinejad Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044329
- Sponsor's protocol ID
- 8900
- Acronym
- BRVO
- Status last verified
- Jan 2010
- First submitted
- 6 Jan 2010
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01044329
- Acronym / sponsor ID
- BRVO / 8900
- Conditions
- Branch Retinal Vein Occlusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Collaborators
- Labbafinejad Medical Center
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 7 Jan 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.
This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal bevacizumab | Active comparator | Drug: Bevacizumab |
| Intravitreal triamcinolone | Active comparator | Drug: Triamcinolone Acetonide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Recent onset (less than 3 months) BRVO
Key exclusion criteria (1 listed)
- Any previous intervention
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 |
|---|---|---|
| BevacizumabIntravitreal, 1.25 mg, 3 times, one month apart. | Drug | Intravitreal bevacizumab |
| Triamcinolone AcetonideIntravitreal, 2 mg, 2 times, two months apart. | Drug | Intravitreal triamcinolone |
Primary outcome
Visual acuity
Time frame: 6 months
1 secondary outcome
central macular thickness
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2010.
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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.
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 Bevacizumab and Triamcinolone Acetonide 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 1 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 7 Jan 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 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 7 Jan 2010.