Clinical trial NCT02452385: Phase 1 Study of CM082 in Patients With wAMD
Official title: Phase 1 Study of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Age-Related Macular Degeneration
Lead sponsor: AnewPharma
Sponsor class: INDUSTRY
Collaborators: name: West China Hospital
First posted: 2015-05-22
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: six months
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of CM082
timeFrame: four weeks
measure: Change in best corrected visual acuity (BCVA) (in number of letters)
timeFrame: six months
measure: Change in Central Retinal Thickness
timeFrame: six months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital，Capital Medical University
state: Beijing
city: Shanghai
country: China
facility: The First People's Hospital of Shanghai
state: Shanghai
city: Chendu
country: China
facility: West China Hospital
state: Sichuan
city: Wenzhou
country: China
facility: The Eye Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: West China Hospital
name: Ming Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: