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

Santen

Status and phase: Completed; Phase 1

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Treatments: Drug: MS-R001 (rapamycin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401115

DR-001

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

1

Experimental group

Description:

Subconjunctival injection

Treatment:

Drug: MS-R001 (rapamycin)

Drug: MS-R001 (rapamycin)

2

Experimental group

Description:

Intraocular injection

Treatment:

Drug: MS-R001 (rapamycin)

Drug: MS-R001 (rapamycin)