A Study in Subjects With Retinal Detachment | NCT00210067

Studies
A Study in Subjects With Retinal Detachment

NCT00210067

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Oct 9, 2015Estimated

Enrollment

14Actual

Phase

Phase 1

Conditions

Retinal Detachment

Interventions

denufosol tetrasodium (INS37217) Intravitreal Injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 2001

Primary Completion Date

Jun 2002Actual

Completion Date

Jun 2002Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2015

Last Update Posted Date

Oct 9, 2015Estimated

Description Module

Brief Summary

The purpose of this trial is to access the tolerability of INS37217 Intravitreal Injection when administered intravitreally in subjects with macula-on or macula-off rhegmatogenous retinal detachment (RRD).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Name	Type	Description	Arm Group Labels	Other Names
denufosol tetrasodium (INS37217) Intravitreal Injection	Drug

Measure	Description	Time Frame
tolerability

Measure	Description	Time Frame
pharmacological activity

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have macula-on or macula-off rhegmatogenous retinal detachment
are eligible for pneumatic retinopexy, with identifiable retinal breaks
are phakic or pseudo-phakic

Exclusion Criteria:

have detachments not of a rhegmatogenous nature
currently have blood in the vitreous, corneal opacity, or other conditions which limit the view of peripheral retina
have evidence of intraocular inflammation (uveitis)
have a history of current condition of uncontrollable, elevated IOP or open-angle glaucoma
have breaks not conducive to a single procedure of pneumatic retinopexy treatment
have proliferative vitreoretinopathy of type C or D
have previously had a vitrectomy or require one
have previously had a scleral buckle procedure

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Amy Schaberg, BSN		Study Director

ID	Term
D012163	Retinal Detachment

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
C465279	denufosol tetrasodium
D058449	Intravitreal Injections

Ancestor Terms

ID	Term
D056965	Injections, Intraocular
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy

Browse Leaves

Not provided

Browse Branches

Not provided