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Withdrawn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
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- WITHDRAWN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
- Secondary Outcome Measures
Name Time Method