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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00401115

Enrollment

Registered

2006-11-17

Start date

2006-09-30

Completion date

2008-06-30

Last updated

2010-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Diabetic Retinopathy

Brief summary

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

Interventions

DRUGMS-R001 (rapamycin)

Subconjunctival injection in various dosages

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope	12 months

Secondary

Measure	Time frame
Visual Acuity	90 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026