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Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension

Primary Purpose

Open-angle Glaucoma, Oular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate Sterile Suspension, 30 mg/mL
Anecortave Acetate Sterile Suspension, 60 mg/mL
Anecortave Acetate Sterile Suspension, 75 mg/mL
Anecortave Acetate Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Anecortave acetate, Open-angle glaucoma, IOP, OHT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patients with any form of glaucoma other than open-angle.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Charleston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

24 mg Anecortave Acetate

48 mg Anecortave Acetate

60 mg Anecortave Acetate

Anecortave Acetate Vehicle

Arm Description

Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye

Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye

Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye

Single depot administration of 0.8 mL in the study eye

Outcomes

Primary Outcome Measures

Mean Intraocular Pressure at 8 am

Secondary Outcome Measures

Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am)

Full Information

First Posted
June 3, 2008
Last Updated
November 27, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00691717
Brief Title
Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title
A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Oular Hypertension
Keywords
Anecortave acetate, Open-angle glaucoma, IOP, OHT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
24 mg Anecortave Acetate
Arm Type
Experimental
Arm Description
Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye
Arm Title
48 mg Anecortave Acetate
Arm Type
Experimental
Arm Description
Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye
Arm Title
60 mg Anecortave Acetate
Arm Type
Experimental
Arm Description
Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye
Arm Title
Anecortave Acetate Vehicle
Arm Type
Placebo Comparator
Arm Description
Single depot administration of 0.8 mL in the study eye
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 30 mg/mL
Intervention Description
Single administration by anterior juxtascleral depot
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 60 mg/mL
Intervention Description
Single administration by anterior juxtascleral depot
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 75 mg/mL
Intervention Description
Single administration by anterior juxtascleral depot
Intervention Type
Other
Intervention Name(s)
Anecortave Acetate Vehicle
Intervention Description
Single administration by anterior juxtascleral depot
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure at 8 am
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am)
Time Frame
Month 3, 8 am

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patients with any form of glaucoma other than open-angle. Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States

12. IPD Sharing Statement

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Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension

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