Central Retinal Vein Occlusion With 20/200 or Worse Visual AcuityNCT01053858
Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
A study testing intravitreal injection in people with Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity
- What is being tested?
- intravitreal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Jan 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion
Who cannot join
- previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset
- Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders
- neovascularization on the disc or elsewhere or rubeosis
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.
- Being tested
- intravitreal injection
- Keywords
- bevacizumab,triamcinolone, intravitreal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injectionProcedure or surgery
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Active comparator | intravitreal bevacizumab or triamcinolone determined by single physician Receives: Procedure: intravitreal injection |
| triamcinolone | Active comparator | Not described Receives: Procedure: intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
Measured: baseline, 1 month, 2 months, 3 months, 6 months, 12 months
Secondary outcomes (1)
central macular thickness by optical coherence tomography
Measured: baseline, 1 month, 2 months, 3 months, 6 months 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Vein Occlusion With 20/200 or Worse Visual AcuityStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053858
- Sponsor's protocol ID
- 2009_10_12
- Status last verified
- Jan 2010
- First submitted
- 14 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
- ClinicalTrials.gov ID
- NCT01053858
- Acronym / sponsor ID
- 2009_10_12
- Keywords
- bevacizumab,triamcinolone, intravitreal injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 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.
To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Active comparator | Procedure: intravitreal injectionintravitreal bevacizumab or triamcinolone determined by single physician |
| triamcinolone | Active comparator | Procedure: intravitreal injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion
Key exclusion criteria (3 listed)
- previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset
- Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders
- neovascularization on the disc or elsewhere or rubeosis
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 |
|---|---|---|
| intravitreal injectionintravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection | Procedure or surgery | bevacizumab, triamcinolone |
Primary outcome
best corrected visual acuity
Time frame: baseline, 1 month, 2 months, 3 months, 6 months, 12 months
1 secondary outcome
central macular thickness by optical coherence tomography
Time frame: baseline, 1 month, 2 months, 3 months, 6 months 12months
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 22 Jan 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravitreal injection in people with Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity, run by Hallym University Medical Center at 1 site in South Korea.
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 3 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 22 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 South Korea. 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 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?
best corrected visual acuity (time frame: baseline, 1 month, 2 months, 3 months, 6 months, 12 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 22 Jan 2010.