Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00315640

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases	Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL Drug: Anecortave Acetate Suspension Depot, 30 mg/mL Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL Other: Anecortave Acetate Vehicle	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anecortave Acetate 3 mg Depot One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye	Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Experimental: Anecortave Acetate 15 mg Depot One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye	Drug: Anecortave Acetate Suspension Depot, 30 mg/mL One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Experimental: Anecortave Acetate 30 mg Depot One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye	Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Other: Anecortave Acetate Vehicle	Other: Anecortave Acetate Vehicle One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Outcome Measures

Primary Outcome Measures

Mean change in IOP at Week 4 from Baseline [Week 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Either gender
18 years of age or older
IOP elevation caused by steroid usage
Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

Under 18 years of age
Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jacksonville	Jacksonville	Florida	United States	32204
2	Miami	Miami	Florida	United States	33136
3	Detroit	Detroit	Michigan	United States	48202
4		Fort Worth	Texas	United States	76134
5	Houston	Houston	Texas	United States	77030
6	San Paulo	San Paulo		Brazil
7	Budapest	Budapest		Hungary
8	Padova	Padova		Italy
9	Amsterdam	Amsterdam		Netherlands
10	Bayamon	Bayamon		Puerto Rico	00961
11	Barcelona	Barcelona		Spain
12	Newcastle upon Tyne	Newcastle upon Tyne		United Kingdom

Sponsors and Collaborators

Alcon Research

Investigators

Study Director: Theresa Landry, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00315640

Other Study ID Numbers:

C-05-03
2005-001598-93

First Posted:

Apr 19, 2006

Last Update Posted:

Nov 28, 2012

Last Verified:

Jan 1, 2010

Keywords provided by Alcon Research

Elevated IOP due to intravitreal triamcinolone therapy

Additional relevant MeSH terms:

Eye Diseases

Hydrocortisone

Anecortave

Study Results

No Results Posted as of Nov 28, 2012