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Study to Treat Uveitis Associated Macular Edema

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00114062
First received: June 13, 2005
Last updated: May 20, 2013
Last verified: May 2013
History of Changes

June 13, 2005
May 20, 2013
May 2005
December 2006   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT00114062 on ClinicalTrials.gov Archive Site
Pilot study - not specified
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Study to Treat Uveitis Associated Macular Edema
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

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cystoid Macular Edema
  • Uveitis
Drug: denufosol tetrasodium (INS37217) Intravitreal Injection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
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December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00114062
06-103
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Merck
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Study Director: Amy Schaberg, BSN
Merck
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP