NCT00656643

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 10, 2013

Status Verified

July 1, 2010

Enrollment Period

1.4 years

First QC Date

April 4, 2008

Last Update Submit

January 8, 2013

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity by ETDRS

    180 days

Secondary Outcomes (2)

  • Foveal central subfield thickness as determined by OCT

    180 days

  • Safety across dose groups versus placebo

    180 days

Study Arms (4)

1

EXPERIMENTAL
Drug: Sirolimus

2

EXPERIMENTAL
Drug: Sirolimus

3

EXPERIMENTAL
Drug: Sirolimus

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SirolimusDRUG

Two subconjunctival injections of 440 micrograms sirolimus each.

Also known as: MS-R001, rapamycin
2
PlaceboDRUG

Two subconjunctival injections of placebo.

Also known as: Vehicle
4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with diabetes mellitus
  • Macular edema secondary to diabetic retinopathy
  • Visual acuity of 20/40 to 20/200 in study eye

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Joel Naor, MD

    MacuSight, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 11, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2009

Study Completion

May 1, 2012

Last Updated

January 10, 2013

Record last verified: 2010-07

Locations

US(1)