A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00135655
First received: August 24, 2005
Last updated: May 20, 2013
Last verified: May 2013

August 24, 2005
May 20, 2013
August 2005
Not Provided
  • safety
  • tolerability
  • retinal thickness
  • visual acuity
Same as current
Complete list of historical versions of study NCT00135655 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema
A Randomized, Double-Masked, Parallel, Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Macular Edema, Cystoid
Drug: denufosol tetrasodium (INS37217) Intravitreal Injection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

Inclusion Criteria:

  • Have persistent post cataract extraction macular edema whose condition is stable
  • Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization
  • Have at least one eligible eye to be treated in the study
  • Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye
  • Have macular edema confirmed by fluorescein angiography

Exclusion Criteria:

  • Have proliferative vitreoretinopathy greater than grade B in either eye
  • Have ocular disorders in the study eye that may confound interpretation of study results
  • Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation
  • Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
  • Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma
  • Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months
  • Have had any ocular implant device for the delivery of therapeutic agents
  • 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
 
NCT00135655
06-104
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Amy Schaberg, BSN Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2013

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