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Completed

NCT Number: NCT00401115

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

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

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Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Retina Consultants of Arizona, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MS-R001 (rapamycin)

Drug

Subconjunctival injection in various dosages

Other names: sirolimus

Primary outcomes

  1. Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope

    Time frame: 12 months

Secondary outcomes

  1. Visual Acuity

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Collaborators

  • MacuSight, Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 17, 2006
Registry last updated
Jul 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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