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

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma; Eye Disease
• Intervention / Treatment: Drug: Placebo; Drug: AMA0076

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States
      • Artesia Clinical Site - Site 02
    • Inglewood, California, United States
      • Inglewood Clinical Site - Site 03
    • Petaluma, California, United States
      • Petaluma Clinical Site - Site 05
  • Connecticut
    • New Haven, Connecticut, United States
      • New Haven Clinical Site - Site 01
  • Georgia
    • Atlanta, Georgia, United States
      • Atlanta Clinical Site - Site 04
  • North Carolina
    • High Point, North Carolina, United States
      • High Point Clinical Site - Site 06

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria include:

1. Adults 30-85 years of age
2. Diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes
3. 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
4. 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:

1. 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).
2. Receiving more than one medication for IOP at time of screening.
3. Central corneal thickness of less than 500 µm or greater than 620 µm.
4. BCVA worse than 20/200 in either eye
5. 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.
6. Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 - AMA0076 Dose A (or vehicle); 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).	Drug: Placebo; Drug: AMA0076
Experimental: Cohort 2: AMA0076 Dose B (or vehicle); 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).	Drug: Placebo; Drug: AMA0076
Experimental: Cohort 3: AMA0076 Dose C (or vehicle); 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).	Drug: Placebo; Drug: AMA0076
Experimental: Cohort 4: AMA0076 Dose D (or vehicle); 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).	Drug: Placebo; Drug: AMA0076

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
intraocular pressure change from baseline.	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events as a measure of safety/tolerability	4 weeks
IOP assessments at weekly visits	Weeks 1, 2, 3, 4

Collaborators and Investigators

• Sponsor: Amakem, NV

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Estimate): July 17, 2013
• Last Update Submitted That Met QC Criteria: July 16, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Eye Diseases
• Other Study ID Numbers: AMA0076-201