Branch Retinal Vein OcclusionPhase 4NCT02527733
Retinal Sensitivity in BRVO After Anti-VEGF Therapy
A Phase 4 study testing Ranibizumab and Ranibizumab and laser in people with Branch Retinal Vein Occlusion, run by Fukushima Medical University at 1 site in Japan.
Trial summary
The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Branch Retinal Vein Occlusion
- What is being tested?
- Ranibizumab and Ranibizumab and laser
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2015to Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment naive patients of branch retinal vein occlusion with visual acuity of less than 1.0 and macular edema of more than 250 micrometers in foveal thickness.
Who cannot join
- Patients with history of treatment for branch retinal vein occlusion, possibility of pregnancy, allergy for ranibizumab, intraocular infection, or severe inflammation will be excluded.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Fukushima Medical University
Fukushima, Fukushima, 9601295
Akira Ojima, M.D., Ph.D, +81-24-548-2111, ao@fmu.ac.jp
About this study
Official title: Retinal Sensitivity in Branch Retinal Vein Occlusion After Anti-VEGF Therapy
The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. The purpose of this study is to compare the changes in retinal sensitivity after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in eyes with BRVO.
- Conditions
- Branch Retinal Vein Occlusion
- Being tested
- Ranibizumab, Ranibizumab and laser
- 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.
RanibizumabDrug
Ranibizumab and laserDrug
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Active comparator | After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Receives: Drug: Ranibizumab |
| Ranibizumab and laser | Active comparator | After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Macular laser photocoagulation will be performed when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Receives: Drug: Ranibizumab and laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan)
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2017 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fukushima Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Ojima, Fukushima Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527733
- Sponsor's protocol ID
- 2129
- Status last verified
- Aug 2015
- First submitted
- 29 Jun 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Sensitivity in Branch Retinal Vein Occlusion After Anti-VEGF Therapy
- ClinicalTrials.gov ID
- NCT02527733
- Acronym / sponsor ID
- 2129
- Conditions
- Branch Retinal Vein Occlusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fukushima Medical UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2017 (estimated)
- First posted
- 19 Aug 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.
The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. The purpose of this study is to compare the changes in retinal sensitivity after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in eyes with BRVO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Active comparator | Drug: RanibizumabAfter initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. |
| Ranibizumab and laser | Active comparator | Drug: Ranibizumab and laserAfter initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Macular laser photocoagulation will be performed when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Treatment naive patients of branch retinal vein occlusion with visual acuity of less than 1.0 and macular edema of more than 250 micrometers in foveal thickness.
Key exclusion criteria (1 listed)
- Patients with history of treatment for branch retinal vein occlusion, possibility of pregnancy, allergy for ranibizumab, intraocular infection, or severe inflammation will be excluded.
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 | Drug | Ranibizumab |
| Ranibizumab and laser | Drug | Ranibizumab and laser |
Primary outcome
Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan)
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Related trials for Branch Retinal Vein Occlusion
RecruitingPhase 2
A Dose-masked Study of Intravitreal Remigromig (EYE103) in Participants With NVAMD or Macular Edema Following BRVO
Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)
Active, not recruitingObservational study
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruitingPhase 3
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
Age-Related Macular Degeneration, Neovascular Age-related Macular Degeneration
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 4 study testing Ranibizumab and Ranibizumab and laser in people with Branch Retinal Vein Occlusion, run by Fukushima Medical 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 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 19 Aug 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akira Ojima, M.D., Ph.D (+81-24-548-2111, ao@fmu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan) (time frame: At 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 19 Aug 2015.