Central Retinal Vein OcclusionCRVONCT02091505
Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO
A study testing Ranibizumab in people with Central Retinal Vein Occlusion, run by Mie University at 1 site in Japan.
Trial summary
Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2013to May 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Macular edema associated with central retinal vein occlusion
- Best corrected visual acuity < 20/30
- Central macular thickness > 300
- Period from symptom onset to treatment < 12 months
Who cannot join
- Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Mie University Hospital
Tsu, Aichi-ken, 514-8507
Mineo Kondo, MD. PhD., +81-59-231-5027, mineo@clin.medic.mie-u.ac.jp
About this study
Official title: Predictive Factors of Treatment Outcome After Intravitreal Injection of Lucentis (Ranibizumab) in Eyes With Macular Edema Associated With Central Retinal Vein Occlusion (CRVO)
Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. We plan to perform comprehensive functional and imaging tests to determine significant predictive factors.
Read the detailed description
The purpose of the present study is to investigate predictive factors of treatment outcome after intravitreal injection of Lucentis (Ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO) using various comprehensive clinical tests including visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, new flicker electroretinogram (ERG) using skin electrodes. Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, and new flicker electroretinogram (ERG) using skin electrodes are performed before and 3, 6, 9, 12 months after the treatment. Predictive factors of treatment outcome are statistically analyzed.
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- Ranibizumab
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal injection of Ranibizumab | Experimental | Not described Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
Measured: 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 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mineo Kondo, Mie University
- Investigators
- Mineo Kondo, MD, PhD, Study director, Mie University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091505
- Sponsor's protocol ID
- MKONDO-CRVO
- Acronym
- CRVO
- Status last verified
- Mar 2014
- First submitted
- 16 Mar 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, Rundle AC, Rubio RG, Murahashi WY; CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1124-1133.e1. doi: 10.1016/j.ophtha.2010.02.022. Epub 2010 Apr 9.
PubMed 20381871Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013 May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.
PubMed 23415775
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Treatment Outcome After Intravitreal Injection of Lucentis (Ranibizumab) in Eyes With Macular Edema Associated With Central Retinal Vein Occlusion (CRVO)
- ClinicalTrials.gov ID
- NCT02091505
- Acronym / sponsor ID
- CRVO / MKONDO-CRVO
- Conditions
- Central Retinal Vein Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mie UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2016 (estimated)
- First posted
- 19 Mar 2014 (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.
Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. We plan to perform comprehensive functional and imaging tests to determine significant predictive factors.
Detailed description
The purpose of the present study is to investigate predictive factors of treatment outcome after intravitreal injection of Lucentis (Ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO) using various comprehensive clinical tests including visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, new flicker electroretinogram (ERG) using skin electrodes. Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, and new flicker electroretinogram (ERG) using skin electrodes are performed before and 3, 6, 9, 12 months after the treatment. Predictive factors of treatment outcome are statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal injection of Ranibizumab | Experimental | Drug: Ranibizumab |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Macular edema associated with central retinal vein occlusion
- Best corrected visual acuity < 20/30
- Central macular thickness > 300
- Period from symptom onset to treatment < 12 months
Key exclusion criteria (1 listed)
- Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)
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 | Intravitreal injection of Ranibizumab |
Primary outcome
Best-corrected visual acuity
Time frame: 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 Mar 2014.
- Background: PubMed 20381871Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, Rundle AC, Rubio RG, Murahashi WY; CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1124-1133.e1. doi: 10.1016/j.ophtha.2010.02.022. Epub 2010 Apr 9.
- Background: PubMed 23415775Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013 May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.
- Department of Ophthalmology, Mie University Graduate School of MedicineLink provided by the sponsor.
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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.
Mineo Kondo, MD, PhD study director
Mie University Hospital
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 in people with Central Retinal Vein Occlusion, run by Mie 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 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 Mar 2014. 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?
Contact Mineo Kondo, MD, PhD (+81-59-231-5027, mineo@clin.medic.mie-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091505, which also lists 2 linked publications.
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 Mar 2014.