A Study in Subjects With Retinal Detachment

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210067
• Other study ID #: 06-101
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: October 8, 2015
• Start date: May 2001
• Est. completion date: June 2002

Study information

• Verified date: October 2015
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Detachment

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	tolerability
Secondary	pharmacological activity