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

Merck Sharp & Dohme (MSD)

Status and phase

Withdrawn

Phase 2

Conditions

Macular Edema, Cystoid

Treatments

Drug: denufosol tetrasodium (INS37217) Intravitreal Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00135655

06-104

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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