Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
NCT ID: NCT00656643
Last Updated: 2013-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2008-06-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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1
Sirolimus
Two subconjunctival injections of 220 micrograms sirolimus each.
2
Sirolimus
Two subconjunctival injections of 440 micrograms sirolimus each.
3
Sirolimus
Two subconjunctival injections of 880 micrograms sirolimus each.
4
Placebo
Two subconjunctival injections of placebo.
Interventions
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Sirolimus
Two subconjunctival injections of 440 micrograms sirolimus each.
Placebo
Two subconjunctival injections of placebo.
Sirolimus
Two subconjunctival injections of 220 micrograms sirolimus each.
Sirolimus
Two subconjunctival injections of 880 micrograms sirolimus each.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Macular edema secondary to diabetic retinopathy
* Visual acuity of 20/40 to 20/200 in study eye
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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MacuSight, Inc.
INDUSTRY
Santen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Naor, MD
Role: STUDY_DIRECTOR
MacuSight, Inc.
Locations
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Retinal Consultants of Arizona
Phoenix, Arizona, United States
Countries
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Other Identifiers
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DR-002
Identifier Type: -
Identifier Source: org_study_id
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