A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension

This study has been terminated.

(Project cancellation)

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00788541

First received: November 7, 2008

Last updated: November 28, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 7, 2008
Last Updated Date	November 28, 2012
Start Date ^ICMJE	December 2008
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 10, 2008)	Mean Intraocular Pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00788541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 10, 2008)	Percent of patients who remain rescue-medication free [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension
Official Title ^ICMJE	A Dose-Volume Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension
Brief Summary	The purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Open-Angle Glaucoma Ocular Hypertension
Intervention ^ICMJE	Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL Administered as an injection into an anterior juxtascleral depot Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL Administered as an injection into an anterior juxtascleral depot Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL Administered as an injection into an anterior juxtascleral depot Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML Administered as an injection into an anterior juxtascleral depot Other: Anecortave Acetate Vehicle Administered as an injection into an anterior juxtascleral depot
Study Arm (s)	Experimental: 3 mg Anecortave Acetate, low volume high dose Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. Intervention: Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL Experimental: 3 mg Anecortave Acetate, high volume low dose Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. Intervention: Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL Experimental: 48 mg Anecortave Acetate, low volume high dose Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. Intervention: Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL Experimental: 48 mg Anecortave Acetate, high volume low dose Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. Intervention: Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML Placebo Comparator: Anecortave Acetate Vehicle, low volume Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months. Intervention: Other: Anecortave Acetate Vehicle Placebo Comparator: Anecortave Acetate Vehicle, high volume Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months. Intervention: Other: Anecortave Acetate Vehicle
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	197
Completion Date	September 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Prior angle surgery in the study eye, severe visual field loss in either eye; Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00788541
Other Study ID Numbers ^ICMJE	C-08-049
Has Data Monitoring Committee	Yes
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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