Suspended

Phase 1 Study of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy

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What is being tested

CM082 tablet

Drug
Who is being recruted

Eye Diseases+1

+ Macular Degeneration

+ Retinal Degeneration

Over 50 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2015
See protocol details

Summary

Principal SponsorAnewPharma
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2015

Actual date on which the first participant was enrolled.

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.

Official TitlePhase 1 Study of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy
NCT02452385
Principal SponsorAnewPharma
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

Criteria

5 inclusion criteria required to participate
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.
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20 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Escalating dose of CM082 tablet starting at 25mg once a day

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Peking University People's Hospital

Beijing, ChinaOpen Peking University People's Hospital in Google Maps
Suspended

Beijing Hospital

Beijing, China
Suspended

Beijing Tongren Hospital，Capital Medical University

Beijing, China
Suspended

The First People's Hospital of Shanghai

Shanghai, China
Suspended6 Study Centers