- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02452385
Phase 1 Study of CM082 in Patients With wAMD
January 8, 2020 updated by: AnewPharma
Phase 1 Study of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With wAMD.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With wAMD.
Patients will receive one of four doses for up to four weeks.
Single/multiple dose pharmacokinetics in these patients will be studied.
At the end of four weeks, investigator will evaluate safety and tolerability and decide whether to continue treatment for a total of six months to further evaluate safety and preliminary efficacy.
Study Type
Interventional
Enrollment (Anticipated)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Peking University People's Hospital
-
Beijing, Beijing, China, 100730
- Beijing Hospital
-
Beijing, Beijing, China, 100730
- Beijing Tongren Hospital,Capital Medical University
-
-
Shanghai
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Shanghai, Shanghai, China, 200080
- The First People's Hospital of Shanghai
-
-
Sichuan
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Chendu, Sichuan, China, 610041
- West China Hospital
-
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Zhejiang
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Wenzhou, Zhejiang, China, 325027
- The Eye Hospital of Wenzhou Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Active choroidal neovascularization (CNV) associated with AMD, as evidenced on fluorescein angiography (FA) and OCT.
- Patients with either no previous anti-VEGF therapy or prior anti-VEGF therapy with evidence of response to treatment and the need for additional treatment.
- Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA 20/40 to 20/320 in the study eye(s).
- Adequate bone marrow, hepatic, and renal functions.
- Willing and able to provide written informed consent, comply with the investigational study protocol and return for all study visits.
Exclusion Criteria:
- Patients with Polypoidal Choroidal Vasculopathy (PCV) as evidenced on Indocyanine Green Angiography (ICG).
- Previous treatment with photodynamic therapy (PDT), external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy.
- CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia.
- Geographic atrophy involving the foveal center in the study eye.
- Any retinal vascular disease or retinal degeneration other than AMD in the study eye.
- Any significant disease in the study eye that could compromise best-corrected visual acuity.
- Cataract surgery in the study eye within three months of screening.
- Trabeculectomy or aqueous shunt or valve in the study eye.
- Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy within thirty (30) days of baseline.
- Females of child bearing potential that are pregnant or not using medically acceptable contraception; males unwilling to take adequate contraceptive measures.
- Serious allergy to or prior significant adverse reaction to fluorescein.
- Undiagnosed acute illness first observed during screening or between screening and baseline, or severe concurrent medical conditions that, in the investigators judgment, represent a safety concern.
- Severe cardiac disease, symptomatic congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization, or arterial thrombosis within 12 months of start of study drug, inadequately controlled hypertension, or ventricular tachyarrhythmias requiring ongoing treatment.
- QTc ≥450 msec or subjects with a history of risk factors for Torsades de Pointes.
- Stroke or transient ischemic attack within 12 months of trial entry.
- Clinically significant impaired renal or hepatic function.
- Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082.
- Serious active infection, other serious medical condition or any other condition that would impair the ability of the subject to administer the investigational drug or to adhere to the study protocol requirements.
- Presence of any condition which, in the judgment of the investigator, would prevent the subject from completing the study.
- Need to take any medicine that is a strong inhibitor or inducer of CYP3A4.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CM082 tablet
Escalating dose of CM082 tablet starting at 25mg once a day
|
CM082 tablets taken orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: six months
|
Incidence of the adverse event after treatment
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the plasma concentration versus time curve (AUC) of CM082
Time Frame: four weeks
|
Single/multiple dose pharmacokinetics in Chinese wAMD patients
|
four weeks
|
Change in best corrected visual acuity (BCVA) (in number of letters)
Time Frame: six months
|
Change from baseline in mean BCVA (ETDRS)
|
six months
|
Change in Central Retinal Thickness
Time Frame: six months
|
Change from baseline in mean central retinal thickness (OCT)
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ming Zhang, MD, West China Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
March 10, 2015
First Submitted That Met QC Criteria
May 20, 2015
First Posted (Estimate)
May 22, 2015
Study Record Updates
Last Update Posted (Actual)
January 13, 2020
Last Update Submitted That Met QC Criteria
January 8, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM082-OPH-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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