A Study in Subjects With Retinal Detachment

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

denufosol tetrasodium (INS37217) Intravitreal Injection

About this trial

This is an interventional treatment trial for Retinal Detachment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

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

Sites / Locations

Outcomes

Primary Outcome Measures

tolerability

Secondary Outcome Measures

pharmacological activity

Full Information

NCT ID

NCT00210067

First Posted

September 13, 2005

Last Updated

October 8, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00210067

Brief Title

A Study in Subjects With Retinal Detachment

Official Title

A Double-Masked, Randomized, Dose-Ranging Study of a Single Intravitreal (IVT) Injection of INS37217 Intravitreal Injection in Subjects With Retinal Detachment

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

May 2001 (undefined)

Primary Completion Date

June 2002 (Actual)

Study Completion Date

June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Detachment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

denufosol tetrasodium (INS37217) Intravitreal Injection

Primary Outcome Measure Information:

Title

tolerability

Secondary Outcome Measure Information:

Title

pharmacological activity

10. Eligibility

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Schaberg, BSN

Official's Role

Study Director

Retinal Detachment

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial