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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00210067

Enrollment

Registered

2005-09-21

Start date

2001-05-31

Completion date

2002-06-30

Last updated

2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

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).

Interventions

DRUGdenufosol tetrasodium (INS37217) Intravitreal Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

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

Design outcomes

Primary

Measure	Time frame
tolerability	—

Secondary

Measure	Time frame
pharmacological activity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026