Nonexudative Age Related Macular DegenerationPhase 2/3NCT01601483
Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
A Phase 2/3 study testing MC-1101 in people with Nonexudative Age Related Macular Degeneration, run by MacuCLEAR, Inc. at 1 site in United States.
Trial summary
This is a Phase II/III vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2 years. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Nonexudative 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
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Mar 2013
- Phase
- Phase 2/3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females age ≥ 50 years and ≤ 85 years;
- Females must be at least 1 year postmenopausal (after last menstrual period) or sterilized;
- Better than 20/80 ETDRS best corrected visual acuity;
- Mild to moderate nonexudative AMD (AMD steps 3 through 8 on Age-Related Eye Disease Study (AREDS) Report No. 17 grading scale);
- Willing to sign informed consent, comply with study protocol requirements, and undergo up to 2.5 hours of testing at each visit;
Who cannot join
- Past or current exudative AMD or any geographic atrophy (on fundus autofluorescence) in study eye;
- Past or current other retinal or choroidal vasculopathy in study eye (e.g. pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy);
- Uncontrolled hypertension (≥ 150 systolic or ≥95 diastolic);
- Diabetes mellitus;
- Glaucoma;
- Lens opacity ≥ grade 3 ARLNS on standard photographs;
Show all 25Show fewer
- Unable to complete biophysical testing;
- Unable to give informed consent;
- Dilated pupil diameter less than 6 millimeters;
- Subjects with a history of a hypersensitivity reaction to the study drug or to any agent used in the components of the study assessment;
- Use of topical ocular medications (other than artificial tear products);
- Anticipated extra- or intraocular intervention during the study period;
- High myopia (refractive error spherical equivalent ≥ -6 diopters);
- Optic neuropathy;
- Neurological conditions that can impair vision (e.g. Parkinson's disease, multiple sclerosis, Alzheimer's disease);
- Liver disease (e.g. cirrhosis, hepatitis);
- History of GI surgery (e.g. bariatric surgery);
- Unwilling or unable to take an AREDS formula vitamin (without beta-carotene/vitamin A);
- Current or past use of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), or deferoxamine;
- Tobacco smoking (currently or within past 5 years);
- Contact lens wearers (not prepared to discontinue lens use);
- Ophthalmic surgery of any kind within 3 months prior to screening visit;
- Participation in any interventional clinical study requiring IRB approval within 3 months of enrollment;
- Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study;
- Known to have AIDS/HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II/III Study of the Efficacy and Safety of Macuclear MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
This is a Phase II/III vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2 years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for these patients.
An analysis of the primary and secondary endpoints will be conducted when all subjects have completed 12, 18 and 24 months.
- Being tested
- MC-1101, MC-1101 Vehicle
- Keywords
- AMD, Dry AMD, Nonexudative AMD, MC-1101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC-1101Drug
1% Ophthalmic Solution TID
MC-1101 VehicleDrug
Ophthalmic solution, TID
| Study group | Role | What they receive |
|---|---|---|
| MC-1101 1% Ophthalmic Solution | Experimental | Not described Receives: Drug: MC-1101 |
| Vehicle control | Placebo comparator | Not described Receives: Drug: MC-1101 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Function
Primary efficacy assessment will be a comparison between groups of the change in visual function at 12 months with additional analyses at 18 and 24 months.
Measured: 12 months
Secondary outcomes (1)
Safety and Tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia)
Evaluate the safety and tolerability (incidence and severity of adverse events, ocular irritability,and ocular hyperemia) of MC-1101 compared to vehicle control at each study visit following treatment for 2 years
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Unmasked without Sponsor's prior knowledge or authorization by the PI.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonexudative 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacuCLEAR, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grant M Comer, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601483
- Sponsor's protocol ID
- MacuCLEAR MC-1101-001
- Status last verified
- Apr 2014
- First submitted
- 15 May 2012
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Study of the Efficacy and Safety of Macuclear MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01601483
- Acronym / sponsor ID
- MacuCLEAR MC-1101-001
- Keywords
- AMD, Dry AMD, Nonexudative AMD, MC-1101
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unmasked without Sponsor's prior knowledge or authorization by the PI.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- MacuCLEAR, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 May 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.
This is a Phase II/III vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2 years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for these patients.
An analysis of the primary and secondary endpoints will be conducted when all subjects have completed 12, 18 and 24 months.
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 |
|---|---|---|
| MC-1101 1% Ophthalmic Solution | Experimental | Drug: MC-1101 |
| Vehicle control | Placebo comparator | Drug: MC-1101 Vehicle |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females age ≥ 50 years and ≤ 85 years;
- Females must be at least 1 year postmenopausal (after last menstrual period) or sterilized;
- Better than 20/80 ETDRS best corrected visual acuity;
- Mild to moderate nonexudative AMD (AMD steps 3 through 8 on Age-Related Eye Disease Study (AREDS) Report No. 17 grading scale);
- Willing to sign informed consent, comply with study protocol requirements, and undergo up to 2.5 hours of testing at each visit;
Key exclusion criteria (25 listed)
- Past or current exudative AMD or any geographic atrophy (on fundus autofluorescence) in study eye;
- Past or current other retinal or choroidal vasculopathy in study eye (e.g. pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy);
- Uncontrolled hypertension (≥ 150 systolic or ≥95 diastolic);
- Diabetes mellitus;
- Glaucoma;
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-11011% Ophthalmic Solution TID | Drug | MC-1101 1% Ophthalmic Solution |
| MC-1101 VehicleOphthalmic solution, TID | Drug | Vehicle control |
Primary outcome
Visual Function
Time frame: 12 months
Primary efficacy assessment will be a comparison between groups of the change in visual function at 12 months with additional analyses at 18 and 24 months.
1 secondary outcome
Safety and Tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Unmasked without Sponsor's prior knowledge or authorization by the PI.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
Related trials for Nonexudative Age Related Macular Degeneration
RecruitingPhase 2
A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Geographic Atrophy of the Macula
Recruiting
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
Age-Related Macular Degeneration, Age-related Macular Degeneration (ARMD)
Active, not recruiting
Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD
Geographic Atrophy
Recruiting
Atrophic Age-related Macular Degeneration Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma
Dry Age-related Macular Degeneration
RecruitingObservational study
Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Age-Related Macular Degeneration, Geographic Atrophy
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.
Grant M Comer, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MC-1101 in people with Nonexudative 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 5 inclusion and 25 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: stopped early, as of the sponsor's last update on 28 Apr 2014. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Unmasked without Sponsor's prior knowledge or authorization by the PI.). Results are not available in the source record.
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?
Visual Function (time frame: 12 months). 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 28 Apr 2014.