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Status unknownNCT03710863Updated Jan 13, 2020

Safety and Tolerability of Oral CM082 in Patients With wAMD

A Phase 2 interventional study of CM082 in Age-Related Macular Degeneration, sponsored by AnewPharma. Status unknown at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by AnewPharma · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a multicenter, open-label, single-arm, phase II Study to Evaluate the safety, tolerability, pharmacokinetics and preliminary Efficacy of intermittent oral dosing of CM082 tablets in Chinese patients with wAMD. The study will be performed in two different parts, dose-escalation phase (Part 1) and dose-expansion phase (Part 2). Subjects will receive CM082 orally twice daily for two weeks followed by two weeks off in four-week cycles. There are two dose levels, 25mg BID and 50mg BID. In part 1, the starting dose of 25mg BID(n=8) will be increased by 100% to the maximum dose of 50mg BID(n=8) if the number of patients who experience dose-limiting toxicities is less than 2 during the first cycle. In part 2, based on the relevant data from the dose escalation study, an expanded enrollment study was conducted at a safe and effective dose.Per dose group will enroll 12-24 patients. All patients will take CM082 until disease progression or unacceptable toxicity. The assessment of the safety and efficacy will be done every four weeks from 2nd-6th cycle and every 12 weeks after. Also, single/multiple dose pharmacokinetics in these patients will be studied.

02

Conditions studied

  • Age-Related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 64 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

AnewPharma is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    CM082 Tablet

    Code Name: CM082 Tablet Other Name: X-82 Dosage and Administration: 25/50mg BID, P.O., two-week on/two-week off in four-week cycles until disease progression or unacceptable toxicity

    Drug: CM082

Interventions

  • DrugCM082

    Subjects will receive CM082 orally twice daily for two weeks followed by two weeks off in four-week cycles. The starting dose of 25mg BID will be increased by 100% to the maximum dose of 50mg BID.The treatment period is tentatively set at 1 year.

    Also known as: X-82

06

What researchers measure

Primary outcomes

  1. Dose-Limiting Toxicity(DLT)

    Any serious adverse event in eye or any ≥3 grade adverse reactions cannot be reduced to below grade 3 after treatment for more than 7 days.

    Time frame: the first cycle(the first four weeks)

Secondary outcomes

  1. Change in Best-Corrected Visual Acuity (BCVA)

    Change from baseline in mean BCVA (ETDRS)

    Time frame: 8 weeks

  2. Change in Choroidal Neovascularization (CNV) size

    Change from baseline in mean CNV size (OCTA, FA/ICG)

    Time frame: 8 weeks

  3. Change in Central Retinal Thickness

    Change from baseline in mean central retinal thickness (OCT)

    Time frame: 8 weeks

  4. Change in ERG

    Change from baseline in ERG

    Time frame: 8 weeks

  5. Proportion Who Develop CNV in the Unaffected Fellow Eye

    Diagnosis by FA

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Renmin Hospital of Wuhan University, Hubei General Hospital
    Wuhan, Hubei 430060, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03710863
Lead sponsor
AnewPharma
Collaborators
Renmin Hospital of Wuhan University
Responsible party
Sponsor
First posted
Oct 18, 2018
Start date
Nov 22, 2018
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Jan 13, 2020

Study contacts

Yin Shen, MD
Contact
yinshen@whu.edu.cn
86-13871550513
Yin Shen
study chair · Renmin Hospital of Wuhan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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