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Phase 1 Study of CM082 in Patients With wAMD

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ClinicalTrials.gov Identifier: NCT02452385
Recruitment Status : Suspended (Sponsor requirements)
First Posted : May 22, 2015
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
AnewPharma

Brief Summary:
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With wAMD.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: CM082 tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy
Study Start Date : March 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CM082 tablet
Escalating dose of CM082 tablet starting at 25mg once a day
Drug: CM082 tablet
CM082 tablets taken orally
Other Name: X-82




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: six months ]
    Incidence of the adverse event after treatment


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of CM082 [ Time Frame: four weeks ]
    Single/multiple dose pharmacokinetics in Chinese wAMD patients

  2. Change in best corrected visual acuity (BCVA) (in number of letters) [ Time Frame: six months ]
    Change from baseline in mean BCVA (ETDRS)

  3. Change in Central Retinal Thickness [ Time Frame: six months ]
    Change from baseline in mean central retinal thickness (OCT)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452385


Locations
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China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Beijing Hospital
Beijing, Beijing, China, 100730
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing, China, 100730
China, Shanghai
The First People's Hospital of Shanghai
Shanghai, Shanghai, China, 200080
China, Sichuan
West China Hospital
Chendu, Sichuan, China, 610041
China, Zhejiang
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
AnewPharma
West China Hospital
Investigators
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Principal Investigator: Ming Zhang, MD West China Hospital
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Responsible Party: AnewPharma
ClinicalTrials.gov Identifier: NCT02452385    
Other Study ID Numbers: CM082-OPH-101
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases