NCT00210067

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

1.1 years

First QC Date

September 13, 2005

Last Update Submit

October 8, 2015

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

  • tolerability

Secondary Outcomes (1)

  • pharmacological activity

Interventions

denufosol tetrasodium (INS37217) Intravitreal InjectionDRUG

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retinal Detachment

Interventions

denufosol tetrasodiumIntravitreal Injections

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Amy Schaberg, BSN

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2001

Primary Completion

June 1, 2002

Study Completion

June 1, 2002

Last Updated

October 9, 2015

Record last verified: 2015-10