Study to Treat Uveitis Associated Macular Edema | NCT00114062

Studies
Study to Treat Uveitis Associated Macular Edema

NCT00114062

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Nov 29, 2016Estimated

Enrollment

15Actual

Phase

Phase 2

Conditions

Cystoid Macular Edema
Uveitis

Interventions

denufosol tetrasodium (INS37217) Intravitreal Injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2005

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Jun 13, 2005

First Submission Date that Met QC Criteria

Jun 13, 2005

First Posted Date

Jun 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2016

Last Update Posted Date

Nov 29, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.

Detailed Description

Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME. Denufosol tetrasodium may also reverse the fluid accumulation of UME.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Name	Type	Description	Arm Group Labels	Other Names
denufosol tetrasodium (INS37217) Intravitreal Injection	Drug

Measure	Description	Time Frame
Pilot study - not specified

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye
Have persistent macular edema and uveitis whose conditions are stable
Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected)
Have an OCT scan with a qualifying retinal thickness in the study eye
Have evidence of macular edema on OCT scan
Have at lease one eligible eye to be treated in the study based on visual acuity.

Exclusion Criteria:

Have proliferative vitreoretinopathy greater than grade B
Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA
Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye
Have ocular disorders in the study eye that may confound interpretation of study results
Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
Have pre-operative spherical equivalent refractive error of more than -10 diopters of myopia in the study eye
Have had any intravitreal or periocular injection or corticosteroids in the study eye during the 3 months prior to screening
Have any ocular implant device for the delivery of therapeutic agents to the eye
Be taking any excluded medications that could obscure or confound study results

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D056965	Injections, Intraocular
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy

Measure	Description	Time Frame
Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.
Assess the utility of denufosol in treating uveitis associated macular edema.