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

Ocular Hypertension Clinical Trial

Official title:

A Dose-Volume Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00788541
• Other study ID #: C-08-049
• Status: Terminated
• Phase: Phase 2
• First received: November 7, 2008
• Last updated: November 28, 2012
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 197
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Anecortave Acetate Sterile Suspension, 6 mg/mL
Administered as an injection into an anterior juxtascleral depot
• Anecortave Acetate Sterile Suspension, 3.75 mg/mL
Administered as an injection into an anterior juxtascleral depot
• Anecortave Acetate Sterile Suspension, 96 mg/mL
Administered as an injection into an anterior juxtascleral depot
• 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

Locations

Country	Name	City	State
United States	Contact Alcon Call Center For Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure		6 months	Yes
Secondary	Percent of patients who remain rescue-medication free		6 Months	No