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

Amakem

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension; Eye Disease

Treatments: Drug: Placebo; Drug: AMA0076

Study type: Interventional

Funder types: Industry

Identifiers

NCT01693315

AMA0076-201

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 4 patient groups

Cohort 1 - AMA0076 Dose A (or vehicle)

Experimental group

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).

Treatment:

Drug: Placebo

Drug: AMA0076

Cohort 2: AMA0076 Dose B (or vehicle)

Experimental group

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).

Treatment:

Drug: Placebo

Drug: AMA0076

Cohort 3: AMA0076 Dose C (or vehicle)

Experimental group

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).

Treatment:

Drug: Placebo

Drug: AMA0076

Cohort 4: AMA0076 Dose D (or vehicle)

Experimental group

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).

Treatment:

Drug: Placebo

Drug: AMA0076