Trial | NCT00401115  Report issue

Title

Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sirolimus ...

  • Study Participants

    50
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 Started
Sep 30
2006
Primary Completion
Jun 30
2008
Study Completion
Jun 30
2008
Last Update
Jul 26
2010
Estimate

Drug MS-R001 (rapamycin)

Subconjunctival injection in various dosages

  • Other names: sirolimus

Drug MS-R001 (rapamycin)

Intraocular injection in various dosages

  • Other names: sirolimus

1 Experimental

Subconjunctival injection

2 Experimental

Intraocular injection

Criteria 

Inclusion Criteria include but are not limited to:

Diagnosed with diabetes mellitus
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
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
No Results Posted