Macular Edema Due to BRVO/CRVONCT01968616
Ranibizumab Treatment for Retinal Vein Occlusion
A study testing Ranibizumab, 0.5mg, Intravitreal in people with Macular Edema Due to BRVO/CRVO, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial summary
In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological features by SD-OCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema Due to BRVO/CRVO
- What is being tested?
- Ranibizumab, 0.5mg, Intravitreal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2013to Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Male or female of aged 18 years or older
- Macula edema secondary to BRVO/CRVO
- Decrease of VA due to macular edema
Who cannot join
- Prior episode of RVO
- Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
- Ocular disorders in the study eye that may confound interpretation of study results
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
- The pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Kyoto University Hospital
Kyoto, Kyoto
Nagahisa Yoshimura, MD, PhD, +81-75-751-3248, nagaeye@kuhp.kyoto-u.ac.jp
Akitaka Tsujikawa, MD. PhD, +81-75-751-3250, tujikawa@kuhp.kyoto-u.ac.jp
About this study
Official title: Predictive Factors of 2-year Visual Outcome in Retinal Vein Occlusion Following Intravitreal Ranibizumab Treatment
In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological features by SD-OCT.
- Conditions
- Macular Edema Due to BRVO/CRVO
- Being tested
- Ranibizumab, 0.5mg, Intravitreal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab, 0.5mg, IntravitrealDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Lucentis 0.5mg | Other | One arm Receives: Drug: Ranibizumab, 0.5mg, Intravitreal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean foveal thickness measured by SD-OCT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Edema Due to BRVO/CRVOStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Nagahisa Yoshimura, Kyoto University, Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968616
- Sponsor's protocol ID
- KY-RV-R
- Status last verified
- Mar 2017
- First submitted
- 20 Oct 2013
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of 2-year Visual Outcome in Retinal Vein Occlusion Following Intravitreal Ranibizumab Treatment
- ClinicalTrials.gov ID
- NCT01968616
- Acronym / sponsor ID
- KY-RV-R
- Conditions
- Macular Edema Due to BRVO/CRVO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2013
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 Oct 2013 (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 retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological features by SD-OCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Lucentis 0.5mg | Other | Drug: Ranibizumab, 0.5mg, IntravitrealOne arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent form
- Male or female of aged 18 years or older
- Macula edema secondary to BRVO/CRVO
- Decrease of VA due to macular edema
Key exclusion criteria (5 listed)
- Prior episode of RVO
- Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
- Ocular disorders in the study eye that may confound interpretation of study results
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
- The pregnant or lactating woman
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 |
|---|---|---|
| Ranibizumab, 0.5mg, Intravitreal | Drug | Intravitreal Lucentis 0.5mg |
Primary outcome
Mean foveal thickness measured by SD-OCT
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
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.
Department of Ophthalmology, Kyoto University Hospital
Kyoto, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranibizumab, 0.5mg, Intravitreal in people with Macular Edema Due to BRVO/CRVO, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
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 4 inclusion and 5 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 10 Mar 2017. 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 Japan. 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?
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?
Mean foveal thickness measured by SD-OCT (time frame: 2 years). 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 10 Mar 2017.