Diabetic Macular EdemaPhase 1/2NCT00308542
A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema
A Phase 1/2 study testing dexamethasone in people with Diabetic Macular Edema, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 12 sites in Japan.
Trial summary
This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- dexamethasone
- How many people
- Not given
- Where
- 12 sitesJapan
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic macular edema
- Criteria for visual acuity and macular thickness are met
Who cannot join
- History of glaucoma
- Known steroid-responder
- Use of systemic steroids
- Use of Warfarin/Heparin
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Study site
Aichi
Study site
Chiba
Study site
Fukuoka
Study site
Gunma
Study site
Hokkaido
Study site
Kagawa
Study site
Kyoto
Study site
Mie
Study site
Miyazaki
Study site
Osaka
Study site
Shiga
Study site
Tokyo
About this study
This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- dexamethasone
- Keywords
- eye diseases, diabetic eye problems
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Study Group, Clinical Development Dept., Study director, Sanwa Kagaku Kenkyusho Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308542
- Sponsor's protocol ID
- DX4002
- Status last verified
- Feb 2012
- First submitted
- 27 Mar 2006
- Last updated
- 13 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00308542
- Acronym / sponsor ID
- DX4002
- Conditions
- Diabetic Macular Edema
- Keywords
- eye diseases, diabetic eye problems
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 29 Mar 2006 (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 safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetic macular edema
- Criteria for visual acuity and macular thickness are met
Key exclusion criteria (5 listed)
- History of glaucoma
- Known steroid-responder
- Use of systemic steroids
- Use of Warfarin/Heparin
- Other protocol-defined exclusion criteria may apply
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 |
|---|---|---|
| dexamethasone | Drug | – |
Primary outcome
Not reported in the source record.
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 13 Feb 2012.
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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.
Clinical Study Group, Clinical Development Dept. study director
Sanwa Kagaku Kenkyusho Co., Ltd.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dexamethasone in people with Diabetic Macular Edema, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 12 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 5 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 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 13 Feb 2012.