Retinal Vein OcclusionPhase 3RVO in JapanNCT01377597
Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion
A Phase 3 study testing ranibizumab in people with Retinal Vein Occlusion, run by Novartis Pharmaceuticals at 8 sites in Japan.
Trial summary
The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 8 sitesJapan
- Study dates
- Jun 2011to Apr 2012
- Phase
- Phase 3
- 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
- Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1
- Best-corrected visual acuity (BCVA):
- CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2
- BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2
Who cannot join
- Pregnant or nursing women
- History of stroke
- Uncontrolled blood pressure
- Active ocular infection or intraocular inflammation in either eye
- Uncontrolled glaucoma in either eye
- Neovascularization of the iris or neovascular glaucoma in either eye
Show all 14Show fewer
- Prior episode of RVO more than 12 months prior to Visit 1 in the study eye
- Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2
- Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye
- Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye
- Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye
- Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye
- Use of any intra-ocular corticosteroid implants in the study eye
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582
Novartis Investigative Site
Kita-gun, Kagawa-ken, 761-0793
Novartis Investigative Site
Kyoto, Kyoto, 606-8507
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8560
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Ohtsu, Shiga, 520-2192
Novartis Investigative Site
Osaka, Osaka, 545-8586
Novartis Investigative Site
Suita, Osaka, 565-0871
About this study
Official title: A 3-month, Phase III, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Monthly Intravitreal Injections as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Branch or Central Retinal Vein Occlusion (RVO)
The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.
- Conditions
- Retinal Vein Occlusion
- Being tested
- ranibizumab
- Keywords
- retinal vein occlusion, branch retinal vein occlusion, central retinal vein occlusion, visual impairment, macular edema, ranibizumab
- Medical subject headings
- Retinal Vein Occlusion, Vision Disorders, Macular Edema
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 |
|---|---|---|
| ranibizumab intravitreal injection | Experimental | Not described Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline
Measured: 3 months
Secondary outcomes (5)
Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit
Measured: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3
Measured: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3
Measured: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3
Measured: 3 months
Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharma AG, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377597
- Sponsor's protocol ID
- CRFB002E2301
- Acronym
- RVO in Japan
- Status last verified
- Nov 2016
- First submitted
- 20 Jun 2011
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Kamei M, Terasaki H, Yoshimura N, Shiraga F, Ogura Y, Grotzfeld AS, Pilz S, Ishibashi T. Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients. Acta Ophthalmol. 2017 Feb;95(1):e29-e35. doi: 10.1111/aos.13196. Epub 2016 Sep 22.
PubMed 27654837
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-month, Phase III, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Monthly Intravitreal Injections as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Branch or Central Retinal Vein Occlusion (RVO)
- ClinicalTrials.gov ID
- NCT01377597
- Acronym / sponsor ID
- RVO in Japan / CRFB002E2301
- Conditions
- Retinal Vein Occlusion
- Keywords
- retinal vein occlusion, branch retinal vein occlusion, central retinal vein occlusion, visual impairment, macular edema, ranibizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Jun 2011 (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 provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranibizumab intravitreal injection | Experimental | Drug: ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1
- Best-corrected visual acuity (BCVA):
- CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2
- BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2
Key exclusion criteria (14 listed)
- Pregnant or nursing women
- History of stroke
- Uncontrolled blood pressure
- Active ocular infection or intraocular inflammation in either eye
- Uncontrolled glaucoma in either eye
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 intravitreal injection |
Primary outcome
Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline
Time frame: 3 months
5 secondary outcomes
Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit
Time frame: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3
Time frame: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3
Time frame: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3
Time frame: 3 months
Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events
Time frame: 3 months
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 18 Nov 2016.
- Results publication: PubMed 27654837Kamei M, Terasaki H, Yoshimura N, Shiraga F, Ogura Y, Grotzfeld AS, Pilz S, Ishibashi T. Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients. Acta Ophthalmol. 2017 Feb;95(1):e29-e35. doi: 10.1111/aos.13196. Epub 2016 Sep 22.
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Retinal Vein Occlusion (RVO)
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Novartis Pharma AG study director
Novartis Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ranibizumab in people with Retinal Vein Occlusion, run by Novartis Pharmaceuticals at 8 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 4 inclusion and 14 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline (time frame: 3 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 NCT01377597, which also lists 1 linked publication.
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 18 Nov 2016.