Macular EdemaNCT02169648
Development of Intravitreal Ranibizumab by Determining the Pathogenesis of Macular Edema With Retinal Vein Occlusion
A study testing ranibizumab in people with Macular Edema and Branch Retinal Vein Occlusion, run by Tokyo Medical University at 2 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by determining the pathogenesis of macular edema, which cause a direct effect on visual function. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Macular Edema, Branch Retinal Vein Occlusion, Central 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
- 100 participants
- Where
- 2 sitesJapan
- Study dates
- Dec 2013to Dec 2015
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Foveal thickness > 300 μm
- Best corrected visual acuity < 20/30
Who cannot join
- History of retinal diseases other than BRVO, glaucoma, uveitis, diabetes mellitus, rubeosis iridis, ocular infections, laser photocoagulation, and intraocular surgery
Trial locations and contacts
2 sites in 1 country.
Japan2 sites, 2 recruiting
- Recruiting
Hachioji Medical Center, Tokyo Medical University
Tokyo, 193-0998
Hidetaka Noma, MD, PhD
- Recruiting
Hachioji Medical Center, Tokyo Medical University
Tokyo, 193-0998
Hidetaka Noma, MD, PhD, 81-42-665-5611 ext. 7648, noma-hide@umin.ac.jp
Hidetaka Noma, MD, PhD
About this study
Official title: Study on the Correlation Between the Treatment Effectiveness of Ranibizumab and the Role of the Cytokines in Macular Edema With Retinal Vein Occlusion
The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by determining the pathogenesis of macular edema, which cause a direct effect on visual function. In particular, we focus on the correlation between the treatment effectiveness of ranibizumab and the role of the cytokines involved in the cause of macular edema.
Read the detailed description
Methodology:
Aqueous humor samples (0.1ml) were obtained during intravitreous injection of ranibizumab to measure the levels of cytokines. Targeted cytokines are follows; IL-1, IL-2, IL-6, IL-8, IL-9, IL-10, IL-12, IL-13, IP-10, MCP-1, MMP-1, MIP-1β, PDGF, VEGF, PlGF, ICAM-1, TNF-α, RANTES, VEGFR-1, VEGFR-2, which has been reported that the expression level is increased in macular edema associated with RVO. Cytokines are measured by multiple ELISA (Luminex). Aqueous humor samples are obtained in the same manner from patients recurred after the first injection or continuous monthly injections. Statistical analysis is conducted to examine the difference of cytokine levels between early or late/incomplete responders of ranibizumab, and predict the number of injections to stabilize cytokine levels.
Number of centers \& patients: Single center, 100 patients
Sample size justification: Sample size calculation was not done, since this study is a single-arm, observational study.
Population: Inclusion criteria: patients with RVO and macular edema
- Being tested
- ranibizumab
- Keywords
- macular edema, branch retinal vein occlusion, central retinal vein occlusion, ranibizumab, cytokines, visual acuity, central macular thickness
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
intravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed.
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Experimental | Experimental: Intravitreal injection of Ranibizumab Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual function by ranibizumab in macular edema with retnal vein occlusion
Mean change in central retinal thickness (CRT) and best corrected visual acuity (BCVA) at month 12
Measured: one year
Secondary outcomes (1)
Cytokine levels by ranibizumab in macular edema with retnal vein occlusion
- Correlation between cytokine levels and mean change in CRT and/or BCVA at month 3, 6, 12,
- Correlation between cytokine levels and number of ranibizumab injections at month 6, 12
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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
- Tokyo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hidetaka Noma, Tokyo Medical University
- Investigators
- Hidetaka Noma, MD, Principal investigator, Hachioji Medical Center, Tokyo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169648
- Sponsor's protocol ID
- H-4
- Status last verified
- Jun 2014
- First submitted
- 13 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between the Treatment Effectiveness of Ranibizumab and the Role of the Cytokines in Macular Edema With Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT02169648
- Acronym / sponsor ID
- H-4
- Keywords
- macular edema, branch retinal vein occlusion, central retinal vein occlusion, ranibizumab, cytokines, visual acuity, central macular thickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tokyo Medical UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Jun 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.
The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by determining the pathogenesis of macular edema, which cause a direct effect on visual function. In particular, we focus on the correlation between the treatment effectiveness of ranibizumab and the role of the cytokines involved in the cause of macular edema.
Detailed description
Methodology:
Aqueous humor samples (0.1ml) were obtained during intravitreous injection of ranibizumab to measure the levels of cytokines. Targeted cytokines are follows; IL-1, IL-2, IL-6, IL-8, IL-9, IL-10, IL-12, IL-13, IP-10, MCP-1, MMP-1, MIP-1β, PDGF, VEGF, PlGF, ICAM-1, TNF-α, RANTES, VEGFR-1, VEGFR-2, which has been reported that the expression level is increased in macular edema associated with RVO. Cytokines are measured by multiple ELISA (Luminex). Aqueous humor samples are obtained in the same manner from patients recurred after the first injection or continuous monthly injections. Statistical analysis is conducted to examine the difference of cytokine levels between early or late/incomplete responders of ranibizumab, and predict the number of injections to stabilize cytokine levels.
Number of centers \& patients: Single center, 100 patients
Sample size justification: Sample size calculation was not done, since this study is a single-arm, observational study.
Population: Inclusion criteria: patients with RVO and macular edema
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Experimental | Drug: ranibizumabExperimental: Intravitreal injection of Ranibizumab |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Foveal thickness > 300 μm
- Best corrected visual acuity < 20/30
Key exclusion criteria (1 listed)
- History of retinal diseases other than BRVO, glaucoma, uveitis, diabetes mellitus, rubeosis iridis, ocular infections, laser photocoagulation, and intraocular surgery
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: Lucentisintravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed. | Drug | ranibizumab |
Primary outcome
Visual function by ranibizumab in macular edema with retnal vein occlusion
Time frame: one year
Mean change in central retinal thickness (CRT) and best corrected visual acuity (BCVA) at month 12
1 secondary outcome
Cytokine levels by ranibizumab in macular edema with retnal vein occlusion
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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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.
Hidetaka Noma, MD principal investigator
Hachioji Medical Center, Tokyo Medical University
2 sites 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 Macular Edema and Branch Retinal Vein Occlusion, run by Tokyo Medical University at 2 sites 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 2 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 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Hidetaka Noma, MD, PhD (81-42-665-5611 ext. 7648, noma-hide@umin.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual function by ranibizumab in macular edema with retnal vein occlusion (time frame: one year). 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 23 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.