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

November 7, 2008
November 28, 2012
December 2008
September 2009   (final data collection date for primary outcome measure)
Mean Intraocular Pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00788541 on ClinicalTrials.gov Archive Site
Percent of patients who remain rescue-medication free [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension
A Dose-Volume Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Open-Angle Glaucoma
  • Ocular Hypertension
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
197
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00788541
C-08-049
Yes
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP