Branch Retinal Vein OcclusionPhase 4NCT02478515
Evaluation of the Usefulness of a PRN Regimen Using Ranibizumab for Macular Edema Due to Branch Retinal Vein Occlusion
A Phase 4 study testing Ranibizumab in people with Branch Retinal Vein Occlusion, run by Nagoya City University at 1 site in Japan.
Trial summary
Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is expected that similar results could be obtained by less frequent IVR. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Branch Retinal Vein Occlusion
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2014to Mar 2019
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Macula edema secondary to BRVO
- BCVA of 77 to 20 letters assessed with the use of ETDRS charts
- CRT ≧250μm
Who cannot join
- Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
- Ocular disorders in the study eye that may confound interpretation of study results
- BCVA over 77 letters between screening and Day 0
- The pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Visual Acuity Improvement of a PRN Regimen Using Ranibizumab for Macular Edema Due to Ischemic and Non- Ischemic Branch Retinal Vein Occlusion.
Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is expected that similar results could be obtained by less frequent IVR. The purpose of this study is to investigate if IVR by PRN is as effective as by monthly. In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area.
Read the detailed description
It was demonstrated in BRAVO study that IVR had great effect for macular edema with BVO both in visual and anatomical outcome. However IVR was done monthly for all patients (except Sham group) during the first 6 months in BRAVO study. It is expected that similar results could be obtained by less frequent IVR, and if so, it will contribute to reduce patient's burden and medical cost. Thus it is necessary to determine the optimal regimen of IVR therapy.
In this study, considering the medical and social circumstances in Japan, the investigators are going to investigate if IVR by PRN is as effective as BRAVO study.In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area (NPA), because VEGF is thought to be released from non-perfused retinal tissue, and VEGF production may be correlated with NPA size and location. The investigators are going to measure the size of NPA semi-quantatively by ultra wide field fluorescein angiography (UWFA) using Optos 200Tx. Then the relationship with macular edema will be studied. The effect of ranibizumab to NPA is controversial. In this study, it will be investigated, too.
- Conditions
- Branch Retinal Vein Occlusion
- Being tested
- Ranibizumab
- Keywords
- ranibizumab, PRN regimen, macular edema, branch retinal vein occlusion
- 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
Also called Lucentis
Intraviteal injection of 0.5mg ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| Intraviteal Ranibizumab 0.5mg | Experimental | Intraviteal Ranibizumab 0.5mg Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: One years
Secondary outcomes (2)
central foveal thickness
Measured: One and two years
Visual acuity
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2019
- Study completionMar 2019
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Yuichiro Ogura, Nagoya City University
- Investigators
- Yuichiro Ogura, Study chair, Nagoya City Univsersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478515
- Sponsor's protocol ID
- PRNNCU001
- Status last verified
- Oct 2016
- First submitted
- 26 Jan 2015
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Acuity Improvement of a PRN Regimen Using Ranibizumab for Macular Edema Due to Ischemic and Non- Ischemic Branch Retinal Vein Occlusion.
- ClinicalTrials.gov ID
- NCT02478515
- Acronym / sponsor ID
- PRNNCU001
- Conditions
- Branch Retinal Vein Occlusion
- Keywords
- ranibizumab, PRN regimen, macular edema, branch retinal vein occlusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 23 Jun 2015 (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.
Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is expected that similar results could be obtained by less frequent IVR. The purpose of this study is to investigate if IVR by PRN is as effective as by monthly. In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area.
Detailed description
It was demonstrated in BRAVO study that IVR had great effect for macular edema with BVO both in visual and anatomical outcome. However IVR was done monthly for all patients (except Sham group) during the first 6 months in BRAVO study. It is expected that similar results could be obtained by less frequent IVR, and if so, it will contribute to reduce patient's burden and medical cost. Thus it is necessary to determine the optimal regimen of IVR therapy.
In this study, considering the medical and social circumstances in Japan, the investigators are going to investigate if IVR by PRN is as effective as BRAVO study.In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area (NPA), because VEGF is thought to be released from non-perfused retinal tissue, and VEGF production may be correlated with NPA size and location. The investigators are going to measure the size of NPA semi-quantatively by ultra wide field fluorescein angiography (UWFA) using Optos 200Tx. Then the relationship with macular edema will be studied. The effect of ranibizumab to NPA is controversial. In this study, it will be investigated, too.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraviteal Ranibizumab 0.5mg | Experimental | Drug: RanibizumabIntraviteal Ranibizumab 0.5mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent form
- Macula edema secondary to BRVO
- BCVA of 77 to 20 letters assessed with the use of ETDRS charts
- CRT ≧250μm
Key exclusion criteria (5 listed)
- Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
- Ocular disorders in the study eye that may confound interpretation of study results
- BCVA over 77 letters between screening and Day 0
- 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 |
|---|---|---|
| RanibizumabAlso: LucentisIntraviteal injection of 0.5mg ranibizumab | Drug | Intraviteal Ranibizumab 0.5mg |
Primary outcome
Visual acuity
Time frame: One years
2 secondary outcomes
central foveal thickness
Time frame: One and two years
Visual acuity
Time frame: Two years
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 20 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Yuichiro Ogura study chair
Nagoya City Univsersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab in people with Branch Retinal Vein Occlusion, run by Nagoya City University 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: finished, as of the sponsor's last update on 20 Aug 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Visual acuity (time frame: One 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 20 Aug 2019.