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This study has been withdrawn prior to enrollment.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
  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:


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135655

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Amy Schaberg, BSN Merck Sharp & Dohme Corp.
  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: May 20, 2013
Health Authority: United States: Food and Drug Administration

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
Macular Edema
Cataract
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on August 28, 2014