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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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