A Study in Subjects With Retinal Detachment

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

Sponsors

Lead Sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
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).

Overall Status Completed
Start Date May 2001
Completion Date June 2002
Primary Completion Date June 2002
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
tolerability
Secondary Outcome
Measure Time Frame
pharmacological activity
Enrollment 14
Condition
Intervention

Intervention Type: Drug

Intervention Name: denufosol tetrasodium (INS37217) Intravitreal Injection

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Overall Official
Last Name Role
Amy Schaberg, BSN Study Director
Verification Date

October 2015

Responsible Party

Type: Sponsor

Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov