Diabetic Macular Edema
Conditions
Brief 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.
Interventions
DRUGSirolimus
Two subconjunctival injections of 440 micrograms sirolimus each.
DRUGPlacebo
Two subconjunctival injections of placebo.
Sponsors
MacuSight, Inc.
Santen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
include but are not limited to: * Diagnosed with diabetes mellitus * Macular edema secondary to diabetic retinopathy * Visual acuity of 20/40 to 20/200 in study eye
Exclusion criteria
include but are not limited to: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity by ETDRS | 180 days |
Secondary
| Measure | Time frame |
|---|---|
| Foveal central subfield thickness as determined by OCT | 180 days |
| Safety across dose groups versus placebo | 180 days |
Countries
United States
Outcome results
None listed