GlaucomaPhase 2NCT01693315
Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma
A Phase 2 study testing AMA0076 in people with Glaucoma and Ocular Hypertension, run by Amakem, NV at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Glaucoma, Ocular Hypertension, Eye Disease
- What is being tested?
- AMA0076
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2012to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Artesia Clinical Site - Site 02
Artesia, California
Atlanta Clinical Site - Site 04
Atlanta, Georgia
High Point Clinical Site - Site 06
High Point, North Carolina
Inglewood Clinical Site - Site 03
Inglewood, California
New Haven Clinical Site - Site 01
New Haven, Connecticut
Petaluma Clinical Site - Site 05
Petaluma, California
About this study
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
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.
- Conditions
- Glaucoma, Ocular Hypertension, Eye Disease
- Being tested
- AMA0076, Placebo
- Medical subject headings
- Glaucoma, Ocular Hypertension, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMA0076Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - AMA0076 Dose A (or vehicle) | Experimental | 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). Receives: Drug: AMA0076; Drug: Placebo |
| Cohort 2: AMA0076 Dose B (or vehicle) | Experimental | 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). Receives: Drug: AMA0076; Drug: Placebo |
| Cohort 3: AMA0076 Dose C (or vehicle) | Experimental | 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). Receives: Drug: AMA0076; Drug: Placebo |
| Cohort 4: AMA0076 Dose D (or vehicle) | Experimental | 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). Receives: Drug: AMA0076; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure change from baseline.
Measured: 4 weeks
Secondary outcomes (2)
Adverse events as a measure of safety/tolerability
Measured: 4 weeks
IOP assessments at weekly visits
Measured: Weeks 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amakem, NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693315
- Sponsor's protocol ID
- AMA0076-201
- Status last verified
- Jul 2013
- First submitted
- 21 Sep 2012
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01693315
- Acronym / sponsor ID
- AMA0076-201
- Conditions
- Glaucoma, Ocular Hypertension, Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Amakem, NVIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - AMA0076 Dose A (or vehicle) | Experimental | Drug: AMA0076, Drug: PlaceboConsecutive, 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). |
| Cohort 2: AMA0076 Dose B (or vehicle) | Experimental | Drug: AMA0076, Drug: PlaceboConsecutive, 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). |
| Cohort 3: AMA0076 Dose C (or vehicle) | Experimental | Drug: AMA0076, Drug: PlaceboConsecutive, 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). |
| Cohort 4: AMA0076 Dose D (or vehicle) | Experimental | Drug: AMA0076, Drug: PlaceboConsecutive, 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). |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMA0076 | Drug | 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) |
| Placebo | Drug | 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) |
Primary outcome
intraocular pressure change from baseline.
Time frame: 4 weeks
2 secondary outcomes
Adverse events as a measure of safety/tolerability
Time frame: 4 weeks
IOP assessments at weekly visits
Time frame: Weeks 1, 2, 3, 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMA0076 in people with Glaucoma and Ocular Hypertension, run by Amakem, NV at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure change from baseline. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.