We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135655
First Posted: August 26, 2005
Last Update Posted: May 21, 2013
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.
Information provided by:
Merck Sharp & Dohme Corp.
  Purpose
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.

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

Study Type: Interventional
Study Design: 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 Post Cataract Extraction Macular Edema

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • safety
  • tolerability
  • retinal thickness
  • visual acuity

Enrollment: 0
Study Start Date: August 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00135655


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Amy Schaberg, BSN Merck Sharp & Dohme Corp.
  More Information

ClinicalTrials.gov Identifier: NCT00135655     History of Changes
Other Study ID Numbers: 06-104
First Submitted: August 24, 2005
First Posted: August 26, 2005
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Merck Sharp & Dohme Corp.:
macular edema
post cataract extraction
cystoid macular edema
post cataract extraction macular edema

Additional relevant MeSH terms:
Edema
Cataract
Macular Edema
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases