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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
  Purpose

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 Intervention Phase
Cystoid Macular Edema
Uveitis
 Drug: denufosol tetrasodium (INS37217) Intravitreal Injection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Pilot study - not specified

Estimated Enrollment: 15
Study Start Date: May 2005
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114062

Sponsors and Collaborators
Merck
Investigators
Study Director: Amy Schaberg, BSN
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00114062     History of Changes
Other Study ID Numbers: 06-103
Study First Received: June 13, 2005
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
uveitis
macular edema
uveitis associated macular edema

Additional relevant MeSH terms:
Edema
Macular Edema
Uveitis
Chorioretinitis
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Uveal Diseases
Retinitis
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on June 13, 2013