Dry Age-related Macular DegenerationPhase 2NCT01002950
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy
A Phase 2 study testing ACU-4429 in people with Dry Age-related Macular Degeneration and Geographic Atrophy, run by Kubota Vision Inc. at 12 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Age-related Macular Degeneration, Geographic Atrophy
- What is being tested?
- ACU-4429
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2009to Oct 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a clinical diagnosis of geographic atrophy, as defined in the protocol
Who cannot join
- Currently receiving or has received a medication prohibited by the protocol
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Covance Clinical Research Unit
Austin, Texas, 78752
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Cleveland Clinic
Cleveland, Ohio, 44195
Covance Clinical Research Unit, Inc.
Dallas, Texas, 75247
Covance Clinical Research Unit, Inc.
Daytona Beach, Florida, 32117
Kresege Eye Institute
Detroit, Michigan, 48201
National Ophthalmic Research Institute
Fort Meyers, Florida, 33912
Covance Clinical Research Unit, Inc.
Honolulu, Hawaii, 96813
New York Eye and Ear Infirmary
New York, New York, 10003
Retinal Consultants of Arizona
Phoenix, Arizona, 85014
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Associated Retinal Consultants, P.C. / William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose Escalation, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACU-4429 in Subjects With Dry Age-Related Macular Degeneration (Geographic Atrophy)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.
- Being tested
- ACU-4429, Matching placebo
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACU-4429Drug
ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days
Matching placeboDrug
Matching placebo tablets taken orally once daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| ACU-4429 tablet | Experimental | Not described Receives: Drug: ACU-4429 |
| Matching placebo tablet | Placebo comparator | Not described Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire
Measured: Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104)
Secondary outcomes (1)
Pharmacokinetics as measured by plasma ACU-4429 drug levels
Measured: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Age-related Macular DegenerationStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubota Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- John W Chandler, MD, Study director, Kubota Vision Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002950
- Sponsor's protocol ID
- 4429-201
- Status last verified
- Feb 2014
- First submitted
- 26 Oct 2009
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yeong JL, Loveman E, Colquitt JL, Royle P, Waugh N, Lois N. Visual cycle modulators versus placebo or observation for the prevention and treatment of geographic atrophy due to age-related macular degeneration. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD013154. doi: 10.1002/14651858.CD013154.pub2.
PubMed 33331670
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose Escalation, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACU-4429 in Subjects With Dry Age-Related Macular Degeneration (Geographic Atrophy)
- ClinicalTrials.gov ID
- NCT01002950
- Acronym / sponsor ID
- 4429-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Oct 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Oct 2009 (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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACU-4429 tablet | Experimental | Drug: ACU-4429 |
| Matching placebo tablet | Placebo comparator | Drug: Matching placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Have a clinical diagnosis of geographic atrophy, as defined in the protocol
Key exclusion criteria (1 listed)
- Currently receiving or has received a medication prohibited by the protocol
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 |
|---|---|---|
| ACU-4429ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days | Drug | ACU-4429 tablet |
| Matching placeboMatching placebo tablets taken orally once daily for 90 days | Drug | Matching placebo tablet |
Primary outcome
Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire
Time frame: Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104)
1 secondary outcome
Pharmacokinetics as measured by plasma ACU-4429 drug levels
Time frame: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90
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 11 Mar 2014.
- Derived from this study: PubMed 33331670Yeong JL, Loveman E, Colquitt JL, Royle P, Waugh N, Lois N. Visual cycle modulators versus placebo or observation for the prevention and treatment of geographic atrophy due to age-related macular degeneration. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD013154. doi: 10.1002/14651858.CD013154.pub2.
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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.
John W Chandler, MD study director
Kubota Vision Inc.
12 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 ACU-4429 in people with Dry Age-related Macular Degeneration and Geographic Atrophy, run by Kubota Vision Inc. at 12 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 1 inclusion and 1 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 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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. Some participants in this study may receive a placebo. 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?
Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire (time frame: Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002950, which also lists 1 linked publication.
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 11 Mar 2014.