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Withdrawn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- WITHDRAWN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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie denufosol tetrasodium's effect on cystoid macular edema post cataract surgery?
How does intravitreal denufosol tetrasodium compare to anti-VEGF agents in treating postoperative macular edema?
Are there specific biomarkers that predict response to denufosol tetrasodium in post cataract macular edema patients?
What adverse events are associated with intravitreal denufosol tetrasodium administration in phase 2 trials?
What are the current alternatives to denufosol tetrasodium for managing cystoid macular edema after cataract extraction?