NCT00401115

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

September 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 26, 2010

Status Verified

July 1, 2010

Enrollment Period

1.8 years

First QC Date

November 15, 2006

Last Update Submit

July 22, 2010

Conditions

Diabetic Macular EdemaDiabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (1)

  • Visual Acuity

    90 days

Study Arms (2)

1

EXPERIMENTAL

Subconjunctival injection

Drug: MS-R001 (rapamycin)

2

EXPERIMENTAL

Intraocular injection

Drug: MS-R001 (rapamycin)

Interventions

MS-R001 (rapamycin)DRUG

Subconjunctival injection in various dosages

Also known as: sirolimus
1

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with diabetes mellitus
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Retina Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Pravin Dugel, M.D.

    Retina Consultants of Arizona

    PRINCIPAL INVESTIGATOR

  • Wayne Solley, M.D.

    Texas Retina Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 17, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 26, 2010

Record last verified: 2010-07

Locations

US(2)