Non-Exudative Age Related Macular DegenerationPhase 2/3McCP2/3NCT02127463
Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating DryAge-Related Macular Degeneration
A Phase 2/3 study testing MC-1101 in people with Non-Exudative 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 non-exudative 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
- Non-Exudative 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2016
- 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 only: At least 1year since last menstrual period or surgically sterilized
- 20/80 or better ETDRS best corrected visual acuity
- Early to intermediate nonexudative AMD (AMD category 3 through 3b on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories
- Willing and able to sign informed consent, comply with study protocol requirements, and undergo at least 2.5 hours of testing at each visit
- Able to reliably to complete biophysical testing
- Willing to take an AREDS2 based formula vitamin as indicated
Who cannot join
- Past or current exudative AMD or central geographic atrophy in study eye; (AMD Category 4 on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories)
- Past or current retinal or choroidal vasculopathy in study eye (e.g. serous or hemorrhagic pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous chorioretinopathy, retinal vein occlusion, sickle cell retinopathy)
- Uncontrolled hypertension (≥ 160 systolic or ≥95 diastolic)
- Glaucoma
- 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
Show all 21Show fewer
- 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 small bowel surgery
- Current or past use for more than 30 days of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), deferoxamine, amiodorone, isoretinoin, or gold
- 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 prior to screening visit of this study
- Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study
- Known to have AIDS/HIV
- Current use of hydralazine
- Any other findings deemed unacceptable by the Principal Investigator or Sponsor
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rocky Mountain Retina Consultants
Murray, Utah, 84107
Kari Rasmussen, BS, 801-264-4444, kmrasmussen@yahoo.com
Katie Roach, RN, 8012644444, katie.roach@rockymountainretina.com
About this study
Official title: Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 1.0% BID in the Treatment of Non-exudative 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 non-exudative 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 Baseline, 1, 3, 6, 12,18 and 24 months.
Read the detailed description
MC-1101is a topically administered drug which in previous clinical studies has been proven to get to the back of the eye. MC-1101is a 505 (b) 2 compound and has FDA Fast Track Status. It is a strong, vasoactive drug which is intended to increase choroidal blood flow.
- Being tested
- MC-1101, MC-1101 Vehicle
- Keywords
- AMD, Dry AMD, Non-Exudative AMD, MC-1101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC-1101Drug
Also called 1% Ophthalmic Solution
Topically, two times a day, morning and bedtime
MC-1101 VehicleDrug
Also called Topical Ophthalmic Solution
Topically, two times a day; morning and bedtime
| Study group | Role | What they receive |
|---|---|---|
| MC-1101 active | Experimental | Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime Receives: Drug: MC-1101 |
| MC-1101 Vehicle Control | Placebo comparator | Topical Drug:
Ophthalmic Solution Topically, two times per day; morning and bedtime 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 by dark adaptation methodology.
Measured: Up to 24 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-1101compared to a vehicle control at each study visit following treatment for 2 years.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Exudative 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MacuCLEAR, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell J Goff, MD, Principal investigator, Rocky Mountain Retina Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127463
- Sponsor's protocol ID
- MC-1101-003
- Acronym
- McCP2/3
- Status last verified
- Apr 2014
- First submitted
- 25 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 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 1.0% BID in the Treatment of Non-exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02127463
- Acronym / sponsor ID
- McCP2/3 / MC-1101-003
- Keywords
- AMD, Dry AMD, Non-Exudative AMD, MC-1101
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MacuCLEAR, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 30 Apr 2014 (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 non-exudative 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 Baseline, 1, 3, 6, 12,18 and 24 months.
Detailed description
MC-1101is a topically administered drug which in previous clinical studies has been proven to get to the back of the eye. MC-1101is a 505 (b) 2 compound and has FDA Fast Track Status. It is a strong, vasoactive drug which is intended to increase choroidal blood flow.
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 active | Experimental | Drug: MC-1101Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime |
| MC-1101 Vehicle Control | Placebo comparator | Drug: MC-1101 VehicleTopical Drug: Ophthalmic Solution Topically, two times per day; morning and bedtime |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females age ≥ 50 years and ≤ 85 years
- Females only: At least 1year since last menstrual period or surgically sterilized
- 20/80 or better ETDRS best corrected visual acuity
- Early to intermediate nonexudative AMD (AMD category 3 through 3b on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories
- Willing and able to sign informed consent, comply with study protocol requirements, and undergo at least 2.5 hours of testing at each visit
Key exclusion criteria (21 listed)
- Past or current exudative AMD or central geographic atrophy in study eye; (AMD Category 4 on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories)
- Past or current retinal or choroidal vasculopathy in study eye (e.g. serous or hemorrhagic pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous chorioretinopathy, retinal vein occlusion, sickle cell retinopathy)
- Uncontrolled hypertension (≥ 160 systolic or ≥95 diastolic)
- Glaucoma
- Dilated pupil diameter less than 6 millimeters
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-1101Also: 1% Ophthalmic SolutionTopically, two times a day, morning and bedtime | Drug | MC-1101 active |
| MC-1101 VehicleAlso: Topical Ophthalmic SolutionTopically, two times a day; morning and bedtime | Drug | MC-1101 Vehicle Control |
Primary outcome
Visual Function
Time frame: Up to 24 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 measured by dark adaptation methodology.
1 secondary outcome
Safety and tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia)
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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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.
Mitchell J Goff, MD principal investigator
Rocky Mountain Retina Consultants
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 Non-Exudative 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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 30 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip G Ralston, MBA (2145775999, pralston@macuclear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Function (time frame: Up to 24 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 30 Apr 2014.