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

Macular Edema, Cystoid Clinical Trial

Official title:

A Randomized, Double-Masked, Parallel, Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00135655
• Other study ID #: 06-104
• Status: Withdrawn
• Phase: Phase 2
• First received: August 24, 2005
• Last updated: May 20, 2013
• Start date: August 2005

Study information

• Verified date: May 2013
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Edema
• Macular Edema
• Macular Edema, Cystoid

Intervention

Drug:
• denufosol tetrasodium (INS37217) Intravitreal Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety
Primary	tolerability
Primary	retinal thickness
Primary	visual acuity