NCT00656643CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Santen Inc.
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Best-corrected visual acuity by ETDRS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Experimental
Intervention: Sirolimus (Drug)
2
Experimental
Intervention: Sirolimus (Drug)
3
Experimental
Intervention: Sirolimus (Drug)
4
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Best-corrected visual acuity by ETDRS
Time Frame: 180 days
Secondary Outcomes
- Foveal central subfield thickness as determined by OCT(180 days)
- Safety across dose groups versus placebo(180 days)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
A Study of Enzalutamide and LY3023414 in Men With Prostate CancerProstate Cancer MetastaticNCT02407054Eli Lilly and Company142
Completed
Phase 2
A Study of LY2623091 in Participants With High Blood PressurePrimary HypertensionNCT02194465Eli Lilly and Company304
Completed
Phase 2
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)SchizophreniaParanoid SchizophreniaNCT00482430Merck Sharp & Dohme LLC50
Completed
Phase 2
A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese PatientsObesityNCT02476019Ionis Pharmaceuticals, Inc.13
Completed
Phase 1
Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT01154348Shionogi34