Branch Retinal Vein OcclusionPhase 3NCT01189526
Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)
A Phase 3 study testing Ranibizumab and macular laser photocoagulation in people with Branch Retinal Vein Occlusion, run by Seoul Retina Investigator Group at 1 site in South Korea.
Trial summary
This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison with macular laser photocoagulation as treatments for macular edema secondary to branch retinal vein occlusion. Characteristics of this study is as below 1. Multicenter, randomized clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Branch Retinal Vein Occlusion
- What is being tested?
- Ranibizumab and macular laser photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Aug 2011
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptom duration < 6 Months, > 4 weeks
- Visual acuity - less than 20/40 (73 letters) more than 20/400 (19 letters) in ETDRS chart
- OCT - center involved retinal thickening : > 250 micrometers
- clear media
- well controlled hypertension (<140/90mmHg) and diabetes (6.5<HbA1c<9.5)
- willing to return for all scheduled visits
Who cannot join
- uveitis,NVG, exudative AMD, diabetic retinopathy, Irvine-Gass syndrome, OIS
- any malignancy
- previous treatment history - laser photocoagulation, intravitreal injection with any drug, vitrectomy
- vitreomacular traction or epiretinal membrane
- intraocular surgery in the study eye within 6 months
- uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications)
- optic neuropathy, amblyopia
- A condition that in the opinion of the investigator would preclude a patient's participation in the study
Trial locations and contacts
1 site in 1 country.
Song Ee Chung, M.D. contact
Yun Taek Kim, M.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Song Ee Chung, M.D., songee129@hanmail.net
Song Ee Chung, M.D.
About this study
Official title: A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion
This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison with macular laser photocoagulation as treatments for macular edema secondary to branch retinal vein occlusion.
Characteristics of this study is as below
- Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs. macular laser photocoagulation)
- After 48 weeks follow up, functional change(visual acuity)and anatomical change (central retinal thickness) would be evaluated
- Conditions
- Branch Retinal Vein Occlusion
- Being tested
- Ranibizumab, macular laser photocoagulation
- Keywords
- Branch retinal vein occlusion, macular edema, intravitreal injection, ranibizumab
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.
macular laser photocoagulationProcedure or surgery
Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.
| Study group | Role | What they receive |
|---|---|---|
| IVRI | Experimental | IVRI : intravitreal ranibizumab (0.5mg) injection Receives: Drug: Ranibizumab |
| Laser | Active comparator | Laser : macular laser photocoagulation Receives: Procedure: macular laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (ETDRS letters)
Measured: 48 weeks
Secondary outcomes (1)
Retinal Thickening
Optical Coherence Tomography measured central retinal thickness
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startJan 2009
- Primary completionAug 2010
- Study completionAug 2011 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul Retina Investigator Group
- Sponsor type
- Research network
- Collaborators
- Samsung Medical Center, Kyungpook National University Hospital
- Investigators
- Se Woong Kang, M.D., Principal investigator, Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of MedicineJae Pil Shin, M.D., Principal investigator, Department of Ophthalmology, Kyungpook National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189526
- Sponsor's protocol ID
- RVOIVRI
- Other IDs
- BRVOIVRI
- Status last verified
- Aug 2010
- First submitted
- 25 Aug 2010
- Last updated
- 26 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01189526
- Acronym / sponsor ID
- RVOIVRI
- Conditions
- Branch Retinal Vein Occlusion
- Keywords
- Branch retinal vein occlusion, macular edema, intravitreal injection, ranibizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul Retina Investigator GroupResearch network
- Collaborators
- Samsung Medical Center, Kyungpook National University Hospital
- Study start
- Jan 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2011 (estimated)
- First posted
- 26 Aug 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 study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison with macular laser photocoagulation as treatments for macular edema secondary to branch retinal vein occlusion.
Characteristics of this study is as below
- Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs. macular laser photocoagulation)
- After 48 weeks follow up, functional change(visual acuity)and anatomical change (central retinal thickness) would be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVRI | Experimental | Drug: RanibizumabIVRI : intravitreal ranibizumab (0.5mg) injection |
| Laser | Active comparator | Procedure: macular laser photocoagulationLaser : macular laser photocoagulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptom duration < 6 Months, > 4 weeks
- Visual acuity - less than 20/40 (73 letters) more than 20/400 (19 letters) in ETDRS chart
- OCT - center involved retinal thickening : > 250 micrometers
- clear media
- well controlled hypertension (<140/90mmHg) and diabetes (6.5<HbA1c<9.5)
Key exclusion criteria (8 listed)
- uveitis,NVG, exudative AMD, diabetic retinopathy, Irvine-Gass syndrome, OIS
- any malignancy
- previous treatment history - laser photocoagulation, intravitreal injection with any drug, vitrectomy
- vitreomacular traction or epiretinal membrane
- intraocular surgery in the study eye within 6 months
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 |
|---|---|---|
| RanibizumabRanibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections. | Drug | IVRI |
| macular laser photocoagulationTreatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice. | Procedure or surgery | Laser |
Primary outcome
Best Corrected Visual Acuity (ETDRS letters)
Time frame: 48 weeks
1 secondary outcome
Retinal Thickening
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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.
Song Ee Chung, M.D. contact
Yun Taek Kim, M.D. contact
Se Woong Kang, M.D. principal investigator
Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Jae Pil Shin, M.D. principal investigator
Department of Ophthalmology, Kyungpook National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab and macular laser photocoagulation in people with Branch Retinal Vein Occlusion, run by Seoul Retina Investigator Group 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 6 inclusion and 8 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 26 Aug 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Song Ee Chung, M.D. (songee129@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (ETDRS letters) (time frame: 48 weeks). 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 26 Aug 2010.