Diabetic Macular EdemaPhase 2/3NCT01411254
Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)
A Phase 2/3 study testing Betamethasone Microsphere (DE-102） Low Dose and Betamethasone Microsphere (DE-102） High Dose in people with Diabetic Macular Edema, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Macular Edema
- 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
- 1 siteJapan
- 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
- Provided signed, written informed consent
- 20 years of age or older with diabetic macular edema
Who cannot join
- Active proliferative diabetic retinopathies (PDR) in the study eye
- Uncontrolled diabetes mellitus and hypertension
- Known steroid-responder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- Betamethasone Microsphere (DE-102） Low Dose, Betamethasone Microsphere (DE-102） High Dose, Sham
- Keywords
- DME
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.
Best Corrected Visual Acuity(BCVA)
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Secondary outcomes (1)
retinal thickness
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 posted8 Aug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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 2/3
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411254
- Sponsor's protocol ID
- 01021103
- Status last verified
- Jul 2014
- First submitted
- 4 Aug 2011
- 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, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01411254
- Acronym / sponsor ID
- 01021103
- Conditions
- Diabetic Macular Edema
- Keywords
- DME
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 8 Aug 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.
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.
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)
- Provided signed, written informed consent
- 20 years of age or older with diabetic macular edema
Key exclusion criteria (3 listed)
- Active proliferative diabetic retinopathies (PDR) in the study eye
- Uncontrolled diabetes mellitus and hypertension
- 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
Best Corrected Visual Acuity(BCVA)
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
1 secondary outcome
retinal thickness
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 Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
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.
1 site in 1 country: 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 Diabetic Macular Edema, run by Santen Pharmaceutical Co., Ltd. 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 2 inclusion and 3 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 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. 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?
Best Corrected Visual Acuity(BCVA). 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.