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

Phase 2

Withdrawn

• Conditions: Macular Edema, Cystoid

• Registration Number: NCT00135655
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-24
• Study First Submitted QC: 2005-08-24
• Study First Posted: 2005-08-26
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
safety
tolerability
retinal thickness
visual acuity