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CompletedNCT00401115Updated Jul 26, 2010

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

A Phase 1 interventional study of MS-R001 (rapamycin) and MS-R001 (rapamycin) in Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Santen Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-26.

Sponsored by Santen Inc. (part of Santen Pharmaceutical Co., Ltd.) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Diabetic Macular Edema
  • Diabetic Retinopathy

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03

In context

Diabetic Retinopathy

791 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 491 interventional studies indexed under Diabetic Retinopathy.

Browse Diabetic Retinopathy studies →

Lead sponsor

Santen Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Browse Santen Inc. studies →All Santen Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with diabetes mellitus
  • Visual acuity of 20/40 to 20/200 in study eye

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    1

    Subconjunctival injection

    Drug: MS-R001 (rapamycin)

  • Experimental
    2

    Intraocular injection

    Drug: MS-R001 (rapamycin)

Interventions

06

What researchers measure

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

07

Study locations

2 sites
  • Retina Consultants of Arizona
    Phoenix, Arizona 85014, United States
  • Texas Retina Associates
    Arlington, Texas 76012, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2006, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2006
First posted
Nov 17, 2006
Start
Sep 2006
Primary completionActual
Jun 2008
CompletionActual
Jun 2008
Last update
Jul 26, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00401115
Lead sponsor
Santen Inc.
Collaborators
MacuSight, Inc.
First posted
Nov 17, 2006
Start date
Sep 2006
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Jul 26, 2010

Study contacts

Pravin Dugel, M.D.
principal investigator · Retina Consultants of Arizona
Wayne Solley, M.D.
principal investigator · Texas Retina Associates

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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