NCT00135655

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

First QC Date

August 24, 2005

Last Update Submit

May 20, 2013

Conditions

Macular Edema, Cystoid

Keywords

macular edemapost cataract extractioncystoid macular edemapost cataract extraction macular edema

Outcome Measures

Primary Outcomes (4)

  • safety

  • tolerability

  • retinal thickness

  • visual acuity

Interventions

denufosol tetrasodium (INS37217) Intravitreal InjectionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Edema

Interventions

denufosol tetrasodiumIntravitreal Injections

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Amy Schaberg, BSN

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

August 1, 2005

Last Updated

May 21, 2013

Record last verified: 2013-05