Safety and Tolerability of Oral CM082 in Patients With wAMD

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Intermittent Oral Dosing of CM082 tablets in Chinese Patients With wAMD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AnewPharma
• Collaborator: Renmin Hospital of Wuhan University
• Treatments: Vorolanib

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 the discontinuation time is at least 5 drug half-lives.

• ETDRS BCVA 20/400 to 20/32 in the study eye(s).

• Adequate bone marrow, hepatic, and renal functions.

• Willing to sign the ICF and comply with the study protocol.

Exclusion Criteria:

• Patients with Polypoidal Choroidal Vasculopathy (PCV) as evidenced on Indocyanine Green Angiography (ICG).

• Geographic atrophy involving the foveal center in the study eye.

• 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.

• Any significant disease in the study eye that could compromise best-corrected visual acuity.

• Clinically significant impaired renal or hepatic function.

• Stroke within 12 months of the first dose or transient ischemic attack within 12 months of the first dose.

• Symptomatic congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization, or arterial thrombosis within 6 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 or other severe ECG abnormalities which are clinically relevant.

• 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 the first dose.

• Allergy to the ingredients of the study drug.

• Women of childbearing age who are pregnant, breast-feeding or not using medically acceptable contraception; males who are unwilling to take adequate contraceptive measures.

• Need to take any medicine that is a strong inhibitor or inducer of CYP3A4.