Age-Related Macular DegenerationPhase 1NCT01013376
A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD
A Phase 1 study testing MC-1101 in people with Age-Related Macular Degeneration, run by MacuCLEAR, Inc. at 1 site in United States.
Trial summary
The safety and comfort of repeated administrations of a topically-administered ophthalmic formulation of MC-1101 will be established through investigator assessments and subject reporting over a 3 day period. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- MC-1101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2009
- Phase
- Phase 1
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of dry AMD or;
- Normal, healthy volunteer
Who cannot join
- Uncontrolled systemic disease
- Women who are pregnant, nursing, or planning a pregnancy during the study's duration
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Pilot, Single-Center, Open-Label Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Non-exudative Age-Related Macular Degeneration
The safety and comfort of repeated administrations of a topically-administered ophthalmic formulation of MC-1101 will be established through investigator assessments and subject reporting over a 3 day period. Safety assessments will be performed on both normal, healthy subjects as well as those with the signs and symptoms of early non-exudative age-related macular degeneration (dry AMD).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- MC-1101, Vehicle
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC-1101Drug
MC-1101 1.0%
VehicleDrug
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Topical administration of MC-1101 Receives: Drug: MC-1101 |
| Vehicle | Placebo comparator | Vehicle Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular safety
Measured: 3 days
Secondary outcomes (1)
Choroidal blood flow assessment
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacuCLEAR, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gail L Torkildsen, M.D., Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013376
- Sponsor's protocol ID
- MC1101-CBF-01
- Status last verified
- Nov 2009
- First submitted
- 12 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Single-Center, Open-Label Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Non-exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01013376
- Acronym / sponsor ID
- MC1101-CBF-01
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- MacuCLEAR, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Nov 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 safety and comfort of repeated administrations of a topically-administered ophthalmic formulation of MC-1101 will be established through investigator assessments and subject reporting over a 3 day period. Safety assessments will be performed on both normal, healthy subjects as well as those with the signs and symptoms of early non-exudative age-related macular degeneration (dry AMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: MC-1101Topical administration of MC-1101 |
| Vehicle | Placebo comparator | Drug: VehicleVehicle |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of dry AMD or;
- Normal, healthy volunteer
Key exclusion criteria (2 listed)
- Uncontrolled systemic disease
- Women who are pregnant, nursing, or planning a pregnancy during the study's duration
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 |
|---|---|---|
| MC-1101MC-1101 1.0% | Drug | Active |
| VehicleVehicle | Drug | Vehicle |
Primary outcome
Ocular safety
Time frame: 3 days
1 secondary outcome
Choroidal blood flow assessment
Time frame: 3 days
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 13 Nov 2009.
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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.
Gail L Torkildsen, M.D. principal investigator
Andover Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MC-1101 in people with Age-Related Macular Degeneration, run by MacuCLEAR, Inc. at 1 site 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 2 inclusion and 2 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 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Ocular safety (time frame: 3 days). 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 13 Nov 2009.