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Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma

Primary Purpose

Glaucoma, Ocular Hypertension, Eye Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AMA0076

Placebo

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria include:

Adults 30-85 years of age
Diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes
Not receiving medication for IOP, or able to stop such medication for a washout period and the duration of the study without significant risk of adverse consequences related to glaucomatous disease
Elevated IOP (≥ 24 and ≤ 34 mm Hg at 8 AM and ≥ 21 and ≤ 34 mm Hg at 10 AM on Screening Two visit and Baseline visit in one or both eyes off treatment

Exclusion Criteria include:

Uncontrolled intraocular hypertension defined as >34 mm Hg at either of the screening/baseline visits (after a washout phase in those subjects who were currently receiving ocular hypotensive therapy).
Receiving more than one medication for IOP at time of screening.
Central corneal thickness of less than 500 µm or greater than 620 µm.
BCVA worse than 20/200 in either eye
Significant visual field loss (ie, mean deviation > 10 db or field loss within 10 degrees of fixation), a new field defect, or progression of an existing field defect in either eye during the year preceding the study.
Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.

Sites / Locations

Artesia Clinical Site - Site 02
Inglewood Clinical Site - Site 03
Petaluma Clinical Site - Site 05
New Haven Clinical Site - Site 01
Atlanta Clinical Site - Site 04
High Point Clinical Site - Site 06

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1 - AMA0076 Dose A (or vehicle)

Cohort 2: AMA0076 Dose B (or vehicle)

Cohort 3: AMA0076 Dose C (or vehicle)

Cohort 4: AMA0076 Dose D (or vehicle)

Arm Description

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).

Outcomes

Primary Outcome Measures

intraocular pressure change from baseline.

Secondary Outcome Measures

Adverse events as a measure of safety/tolerability

IOP assessments at weekly visits

Full Information

NCT ID

NCT01693315

First Posted

September 21, 2012

Last Updated

July 16, 2013

Sponsor

Amakem, NV

1. Study Identification

Unique Protocol Identification Number

NCT01693315

Brief Title

Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma

Official Title

A Phase 2a, Randomized, Double-masked, Placebo-controlled, Dose-escalation Study of AMA0076 in Topical Ocular Formulation for Safety, Tolerability and Efficacy in Reduction of Intraocular Pressure in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amakem, NV

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this dose-escalation study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular hypertension or primary open-angle glaucoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Ocular Hypertension, Eye Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 - AMA0076 Dose A (or vehicle)

Arm Type

Experimental

Arm Description

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).

Arm Title

Cohort 2: AMA0076 Dose B (or vehicle)

Arm Type

Experimental

Arm Description

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).

Arm Title

Cohort 3: AMA0076 Dose C (or vehicle)

Arm Type

Experimental

Arm Description

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).

Arm Title

Cohort 4: AMA0076 Dose D (or vehicle)

Arm Type

Experimental

Arm Description

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).

Intervention Type

Drug

Intervention Name(s)

AMA0076

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

intraocular pressure change from baseline.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Adverse events as a measure of safety/tolerability

Time Frame

4 weeks

Title

IOP assessments at weekly visits

Time Frame

Weeks 1, 2, 3, 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria include: Adults 30-85 years of age Diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes Not receiving medication for IOP, or able to stop such medication for a washout period and the duration of the study without significant risk of adverse consequences related to glaucomatous disease Elevated IOP (≥ 24 and ≤ 34 mm Hg at 8 AM and ≥ 21 and ≤ 34 mm Hg at 10 AM on Screening Two visit and Baseline visit in one or both eyes off treatment Exclusion Criteria include: Uncontrolled intraocular hypertension defined as >34 mm Hg at either of the screening/baseline visits (after a washout phase in those subjects who were currently receiving ocular hypotensive therapy). Receiving more than one medication for IOP at time of screening. Central corneal thickness of less than 500 µm or greater than 620 µm. BCVA worse than 20/200 in either eye Significant visual field loss (ie, mean deviation > 10 db or field loss within 10 degrees of fixation), a new field defect, or progression of an existing field defect in either eye during the year preceding the study. Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.

Facility Information:

Facility Name

Artesia Clinical Site - Site 02

City

Artesia

State/Province

California

Country

United States

Facility Name

Inglewood Clinical Site - Site 03

City

Inglewood

State/Province

California

Country

United States

Facility Name

Petaluma Clinical Site - Site 05

City

Petaluma

State/Province

California

Country

United States

Facility Name

New Haven Clinical Site - Site 01

City

New Haven

State/Province

Connecticut

Country

United States

Facility Name

Atlanta Clinical Site - Site 04

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

High Point Clinical Site - Site 06

City

High Point

State/Province

North Carolina

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma

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