Text Size

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

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00135655
First received: August 24, 2005
Last updated: July 25, 2007
Last verified: July 2007
History of Changes
  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
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 Post Cataract Extraction Macular Edema

Resource links provided by NLM:

MedlinePlus related topics: Cataract Edema
U.S. FDA Resources

Further study details as provided by Merck:

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

Estimated Enrollment: 15
Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135655

Locations
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280
United States, Maryland
Johns Hopkins School of Medicine, Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9277
United States, New York
The New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Texas
Austin Retina Associates
Austin, Texas, United States, 78705
Sponsors and Collaborators
Merck
Investigators
Study Director: Amy Schaberg, BSN Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00135655     History of Changes
Other Study ID Numbers: 06-104
Study First Received: August 24, 2005
Last Updated: July 25, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
macular edema
post cataract extraction
cystoid macular edema
post cataract extraction macular edema

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

ClinicalTrials.gov processed this record on May 16, 2013