Diabetic Macular EdemaPhase 1NCT00401115
Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
A Phase 1 study testing MS-R001 (rapamycin) in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Santen Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Diabetic Retinopathy
- What is being tested?
- MS-R001 (rapamycin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Jun 2008
- Phase
- Phase 1
- 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
- Diagnosed with diabetes mellitus
- Visual acuity of 20/40 to 20/200 in study eye
Who cannot join
- Any other ocular disease that could compromise vision in the study eye
- Intraocular surgery of the study eye within 90 days prior to study start
- Capsulotomy of the study eye within 30 days prior to study start
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Retina Associates
Arlington, Texas, 76012
Retina Consultants of Arizona
Phoenix, Arizona, 85014
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Being tested
- MS-R001 (rapamycin)
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS-R001 (rapamycin)Drug
Also called sirolimus
Subconjunctival injection in various dosages
MS-R001 (rapamycin)Drug
Also called sirolimus
Intraocular injection in various dosages
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subconjunctival injection Receives: Drug: MS-R001 (rapamycin) |
| 2 | Experimental | Intraocular injection Receives: Drug: MS-R001 (rapamycin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope
Measured: 12 months
Secondary outcomes (1)
Visual Acuity
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJun 2008
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MacuSight, Inc.
- Investigators
- Pravin Dugel, M.D., Principal investigator, Retina Consultants of ArizonaWayne Solley, M.D., Principal investigator, Texas Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401115
- Sponsor's protocol ID
- DR-001
- Status last verified
- Jul 2010
- First submitted
- 15 Nov 2006
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT00401115
- Acronym / sponsor ID
- DR-001
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Collaborators
- MacuSight, Inc.
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Nov 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.
The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MS-R001 (rapamycin)Subconjunctival injection |
| 2 | Experimental | Drug: MS-R001 (rapamycin)Intraocular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with diabetes mellitus
- Visual acuity of 20/40 to 20/200 in study eye
Key exclusion criteria (3 listed)
- Any other ocular disease that could compromise vision in the study eye
- Intraocular surgery of the study eye within 90 days prior to study start
- Capsulotomy of the study eye within 30 days prior to study start
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 |
|---|---|---|
| MS-R001 (rapamycin)Also: sirolimusSubconjunctival injection in various dosages | Drug | 1 |
| MS-R001 (rapamycin)Also: sirolimusIntraocular injection in various dosages | Drug | 2 |
Primary outcome
Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope
Time frame: 12 months
1 secondary outcome
Visual Acuity
Time frame: 90 days
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 26 Jul 2010.
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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.
Pravin Dugel, M.D. principal investigator
Retina Consultants of Arizona
Wayne Solley, M.D. principal investigator
Texas Retina Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MS-R001 (rapamycin) in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Santen Inc. at 2 sites in United States.
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 26 Jul 2010. 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 United States. 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 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.
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?
Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope (time frame: 12 months). 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 26 Jul 2010.