Macular Edema Following Branch Retinal Vein OcclusionPhase 2/3NCT01512901
Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI)
A Phase 2/3 study testing Betamethasone Microsphere (DE-102） Low Dose and Betamethasone Microsphere (DE-102） High Dose in people with Macular Edema Following Branch Retinal Vein Occlusion, run by Santen Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
Trial summary
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Macular Edema Following Branch Retinal Vein Occlusion
- What is being tested?
- Betamethasone Microsphere (DE-102） Low Dose and Betamethasone Microsphere (DE-102） High Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 2 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years of age or older
- Diagnosis of macular edema following branch retinal vein occlusion
Who cannot join
- BCVA ETDRS letter score in non-study eye < 35
- Known steroid-responder
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Sham Controlled, Multicenter, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion
- Being tested
- Betamethasone Microsphere (DE-102） Low Dose, Betamethasone Microsphere (DE-102） High Dose, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone Microsphere (DE-102） Low DoseDrug
Betamethasone Microsphere (DE-102） High DoseDrug
ShamDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Betamethasone Microsphere (DE-102） Low Dose |
| 2 | Experimental | Not described Receives: Drug: Betamethasone Microsphere (DE-102） High Dose |
| 3 | Sham comparator | Not described Receives: Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Secondary outcomes (1)
Change in retinal thickness from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Edema Following 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 2/3
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512901
- Sponsor's protocol ID
- 01021104
- Status last verified
- Jul 2014
- First submitted
- 15 Jan 2012
- Last updated
- 21 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham Controlled, Multicenter, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01512901
- Acronym / sponsor ID
- 01021104
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 19 Jan 2012 (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.
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Betamethasone Microsphere (DE-102） Low Dose |
| 2 | Experimental | Drug: Betamethasone Microsphere (DE-102） High Dose |
| 3 | Sham comparator | Drug: Sham |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20 years of age or older
- Diagnosis of macular edema following branch retinal vein occlusion
Key exclusion criteria (2 listed)
- BCVA ETDRS letter score in non-study eye < 35
- Known steroid-responder
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 |
|---|---|---|
| Betamethasone Microsphere (DE-102） Low Dose | Drug | 1 |
| Betamethasone Microsphere (DE-102） High Dose | Drug | 2 |
| Sham | Drug | 3 |
Primary outcome
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
1 secondary outcome
Change in retinal thickness from baseline
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 21 Jul 2014.
Related trials for Macular Edema Following Branch Retinal Vein Occlusion
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Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Betamethasone Microsphere (DE-102） Low Dose and Betamethasone Microsphere (DE-102） High Dose in people with Macular Edema Following Branch Retinal Vein Occlusion, run by Santen Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
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 2 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 21 Jul 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, South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score. 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 21 Jul 2014.