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Study to Treat Uveitis Associated Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00114062
Recruitment Status : Terminated
First Posted : June 14, 2005
Last Update Posted : November 29, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Cystoid Macular Edema Uveitis Drug: denufosol tetrasodium (INS37217) Intravitreal Injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked, Parallel Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Uveitis Associated Macular Edema
Study Start Date : September 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Primary Outcome Measures :
  1. Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.
  2. Assess the utility of denufosol in treating uveitis associated macular edema.

Secondary Outcome Measures :
  1. Pilot study - not specified

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00114062

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Amy Schaberg, BSN
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00114062    
Other Study ID Numbers: 06-103
First Posted: June 14, 2005    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Keywords provided by Merck Sharp & Dohme Corp.:
macular edema
uveitis associated macular edema
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases