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OpenTrials
Completed

NCT Number: NCT00656643

Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

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
  • Macular edema secondary to diabetic retinopathy
  • 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
  • Any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery
  • Capsulotomy of the study eye within 30 days prior to study start

Treatment and study plan

sirolimus

Drug

Two subconjunctival injections of 440 micrograms sirolimus each.

Other names: MS-R001, rapamycin

Placebo

Drug

Two subconjunctival injections of placebo.

Other names: Vehicle

Primary outcomes

  1. Best-corrected visual acuity by ETDRS

    Time frame: 180 days

Secondary outcomes

  1. Foveal central subfield thickness as determined by OCT

    Time frame: 180 days

  2. Safety across dose groups versus placebo

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Collaborators

  • MacuSight, Inc.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Apr 11, 2008
Registry last updated
Jan 10, 2013

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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