Diabetic Macular EdemaPhase 2NCT00656643
Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
A Phase 2 study testing Sirolimus in people with Diabetic Macular Edema, run by Santen Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Sirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2012
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with diabetes mellitus
- Macular edema secondary to diabetic retinopathy
- 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
- Any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery
- Capsulotomy of the study eye within 30 days prior to study start
Trial locations and contacts
1 site in 1 country.
United States1 site
Retinal Consultants of Arizona
Phoenix, Arizona, 85014
About this study
Official title: A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injections of Sirolimus in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- Sirolimus, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called MS-R001, rapamycin
Two subconjunctival injections of 440 micrograms sirolimus each.
PlaceboDrug
Also called Vehicle
Two subconjunctival injections of placebo.
SirolimusDrug
Also called MS-R003, rapamycin
Two subconjunctival injections of 220 micrograms sirolimus each.
SirolimusDrug
Also called MS-R002, rapamycin
Two subconjunctival injections of 880 micrograms sirolimus each.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Sirolimus |
| 2 | Experimental | Not described Receives: Drug: Sirolimus |
| 3 | Experimental | Not described Receives: Drug: Sirolimus |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity by ETDRS
Measured: 180 days
Secondary outcomes (2)
Foveal central subfield thickness as determined by OCT
Measured: 180 days
Safety across dose groups versus placebo
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2009
- Study completionMay 2012
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MacuSight, Inc.
- Responsible party
- Sponsor
- Investigators
- Joel Naor, MD, Study director, MacuSight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656643
- Sponsor's protocol ID
- DR-002
- Status last verified
- Jul 2010
- First submitted
- 4 Apr 2008
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injections of Sirolimus in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT00656643
- Acronym / sponsor ID
- DR-002
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Collaborators
- MacuSight, Inc.
- Study start
- Jun 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Apr 2008 (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 efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sirolimus |
| 2 | Experimental | Drug: Sirolimus |
| 3 | Experimental | Drug: Sirolimus |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with diabetes mellitus
- Macular edema secondary to diabetic retinopathy
- 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
- Any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery
- 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 |
|---|---|---|
| SirolimusAlso: MS-R001, rapamycinTwo subconjunctival injections of 440 micrograms sirolimus each. | Drug | 2 |
| PlaceboAlso: VehicleTwo subconjunctival injections of placebo. | Drug | 4 |
| SirolimusAlso: MS-R003, rapamycinTwo subconjunctival injections of 220 micrograms sirolimus each. | Drug | 1 |
| SirolimusAlso: MS-R002, rapamycinTwo subconjunctival injections of 880 micrograms sirolimus each. | Drug | 3 |
Primary outcome
Best-corrected visual acuity by ETDRS
Time frame: 180 days
2 secondary outcomes
Foveal central subfield thickness as determined by OCT
Time frame: 180 days
Safety across dose groups versus placebo
Time frame: 180 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 10 Jan 2013.
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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.
Joel Naor, MD study director
MacuSight, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus in people with Diabetic Macular Edema, run by Santen Inc. at 1 site 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 3 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 10 Jan 2013. 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 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. 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 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.
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 by ETDRS (time frame: 180 days). 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 10 Jan 2013.