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Wet Age-related Macular DegenerationPhase 1NCT04884399

Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD

A Phase 1 study testing CMAB818 and Lucentis® in people with Wet Age-related Macular Degeneration, run by Shanghai Biomabs Pharmaceutical Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics, pharmacodynamics and efficacy of CMAB818 and Lucentis® in patients with wet age-related macular degeneration. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
CMAB818 and Lucentis®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
4 sitesChina
Study dates
3 Jun 2021to 22 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent, and able to receive follow-up according to the time stipulated by the trial;
  • 50 years≤age≤80 years, male or female;
  • The target eye must meet the following requirements: newly occurring or relapsed subfoveal and perifoveal active choroidal neovascularization (CNV) lesions secondary to AMD; the best corrected visual acuity between 78-19 letters (including the boundary value, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, equivalent to Snellen visual acuity of 20/32 to 20/400); no refractive media opacity or myosis affecting fundus examination;
  • The best corrected visual acuity of the subject's non-target eye≥19 letters (using ETDRS charts, equivalent to Snellen visual acuity of 20/400).

Who cannot join

  • Previously received anti-VEGF drug treatment in either eye within 3 months before screening (e.g., aflibercept<Eylea®>, ranibizumab<Lucentis®>, bevacizumab<Avastin®>, Conbercept<Lumitin®>, etc.);
  • Active eye infection in either eye within 1 months before screening (including but not limited to Blepharitis, Conjunctivitis infective, Keratitis, Scleritis, Endophthalmitis);
  • History of vitreous hemorrhage within 3 months before screening;
  • History or presence of uncontrolled glaucoma (defined as intraocular pressure(IOP)>25 mmHg despite treatment with maximal medical therapy),or the optic fovea/optical disc ratio of the target eye caused by severe glaucoma > 0.8;
  • Previously received subconjunctival/intravitreal corticosteroids injection within 3 months (including subconjunctival/intravitreal long-acting implants within 6 months), or local ocular corticosteroids treatment in the target eye within 1 month before screening;
  • Previously received the following ophthalmic surgery such as verteporfin photodynamic therapy (PDT), macular translocation, glaucoma filtering, subfoveal laser photocoagulation, vitrectomy and transpupillary thermotherapy, and other submacular surgery or surgery used to treat age-related macular degeneration in the target eye;
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  • Other ocular diseases other than wAMD that affect the central vision, such as dry AMD, venous occlusion, uveitis, diabetic retinopathy, vascular-like streaks, pathological myopia, retinal detachment, macular hole, etc. in the target eye;
  • Aphakia (excluding intraocular lenses) or rupture of the posterior lens capsule in the target eye [except for yttrium aluminum garnet (YAG) laser posterior capsulotomy after intraocular lens implantation];
  • History of rhegmatogenous retinal detachment or macular hole retinal detachment (stage 3 or 4), with retinal detachment, retinal pigment epithelial tear, or retinal traction in the macular area and epiretinal disease in the macular area in the target eye;
  • Current use or may need to use systemic drugs that can cause crystal toxicity, such as psoralen, risedronate sodium, tamoxifen, etc.;
  • Allergy to fluorescein sodium or indocyanine green, protein products for treatment or diagnosis, and more than 2 drugs and/or non-drugs;
  • History of surgical operations (except for minimally invasive surgery that has healed) or currently unhealed wounds, moderate to severe ulcers, fractures, etc. within 1 month before screening;
  • Presence of infectious diseases that require oral, intramuscular or intravenous administration;
  • Presence of active diffuse intravascular coagulation or obvious bleeding tendency or abnormal coagulation function before screening (prothrombin time ≥ 3 seconds of upper limit of normal value, activated partial thromboplastin time ≥ 10 seconds of upper limit of normal value);
  • History of myocardial infarction, cerebral infarction, unstable angina, coronary revascularization, New York College of Cardiology (NYHA) grade ≥ grade II cardiac insufficiency, severely unstable ventricular arrhythmia, and cerebrovascular accident (including transient ischemic attack) before screening;
  • Presence of systemic immune diseases (including but not limited to systemic lupus erythematosus, immune hemolytic anemia, hyperthyroidism);
  • Uncontrolled hypertension(defined assystolic blood pressure≥160 mmHg and/or diastolic blood pressure≥100 mmHg diastolic despite treatment with antihypertensive drugs;
  • Diabetes with uncontrolled blood glucose (defined as fasting blood glucose≥7.0 mmol/L);
  • Any uncontrollable clinical problems (including but not limited to serious mental, neurological, respiratory and other system diseases, as well as malignant tumors);
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) higher than 1.5 times the laboratory upper limit of normal (ULN) and/or blood creatinine is higher than ULN and the investigator judges that the abnormality has clinical significance;
  • Concurrent with hepatitis B (positive hepatitis B virus surface antigen), hepatitis C (positive hepatitis C virus antibody), AIDS (positive human immunodeficiency virus antibody) or syphilis (positive syphilis antibody);
  • Pregnant and lactating women;
  • Refuse to take effective contraceptive measures during childbearing age throughout the study period;
  • Participated in any drug (excluding vitamins and minerals) and medical device clinical trials within 3 months before screening (if the drug has a long half-life and its 5 half-life time is greater than 3 months, then choose the 5 half-life time);
  • Any other situations that investigator thinks the subject is inappropriate to participate in this study.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Peking University People'S Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality, 100730

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

Other trials in China

About this study

Official title: A Randomized, Double-blind, Two-group Parallel, Positive-controlled Clinical Phase I Trial Comparing the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of CMAB818 and Lucentis® in Patients With Wet Age-related Macular Degeneration.

This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics, pharmacodynamics and efficacy of CMAB818 and Lucentis® in patients with wet age-related macular degeneration.

Read the detailed description

This is a phase I, randomized, double-blind, two-group parallel, positive-controlled clinical trial at four sites. Subjects will be sequentially enrolled according to the protocol in one of two cohorts and receive a single 0.5mg of CMAB818 or Lucentis® through intravitreal injection.

The primary objective is to assess the initial clinical safety of intravitreal injection of CMAB818 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD).

The secondary objective are to assess immnogenicity, pharmacokinetic, pharmacodynamics and the initial clinical efficacy of intravitreal injection of CMAB818 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD).

Being tested
CMAB818, Lucentis®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMAB818Drug

    Also called Ranibizumab Injection

    vascular endothelial growth factor (VEGF) inhibitor

  • Lucentis®Drug

    Also called Ranibizumab Injection

    vascular endothelial growth factor (VEGF) inhibitor

Study groups in NCT04884399
Study groupRoleWhat they receive
CMAB818Experimental0.5 mg by intravitreal injection once on the first day.
Receives: Drug: CMAB818
Lucentis®Active comparator0.5 mg by intravitreal injection once on the first day.
Receives: Drug: Lucentis®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events That Are Related to Treatment

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant graded according to the common terminology criteria for adverse events (CTCAE) v.5.0 criteria, including clinically-significant changes in physical examinations, laboratory safety tests, ECG and vital signs

    Measured: 0~42 days

Secondary outcomes (11)

  1. Number of Participants With anti-drug antibody

    Blood samples were collected at the following time point: pre-dose, D14, D28, and D42

    Measured: 0~42 days

  2. Percentage of neutralizing antibody

    Subjects with a positive antibody response to ranibizumab were determined to test neutralizing antibody

    Measured: 0~42 days

  3. AUC(0-t)

    Blood samples were collected to measure the area under the concentration time curve from time 0 to last time

    Measured: 0~42 days

  4. Cmax

    Blood samples were collected to measure maximum concentration

    Measured: 0~42 days

  5. CL

    Blood samples were collected to measure clearance rate

    Measured: 0~42 days

  6. Half-life (t1/2)

    Blood samples were collected to measure half-life time

    Measured: 0~42 days

  7. Pharmacodynamics

    The plasma VEGF concentration from baseline were measured

    Measured: 0~42 days

  8. Mean change in best corrected visual acuity (BCVA) from baseline

    BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visualacuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient

    Measured: 0~42 days

  9. Mean change in central retinal thickness from baseline

    Central retinal thickness was measured using the Optical Coherence Tomography

    Measured: 0~42 days

  10. Mean change in lesion area from baseline

    The lesion area was measured using Fundus Fluorescein Angiography

    Measured: 0~42 days

  11. Mean change in leakage area from baseline

    The leakage area was measured using Fundus Fluorescein Angiography

    Measured: 0~42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start3 Jun 2021
  3. Primary completion22 Dec 2022
  4. Study completion22 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04884399
Sponsor's protocol ID
CMAB818-I-001
Status last verified
Mar 2024
First submitted
6 May 2021
Last updated
28 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CMAB818 and Lucentis® in people with Wet Age-related Macular Degeneration, run by Shanghai Biomabs Pharmaceutical Co., Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events That Are Related to Treatment (time frame: 0~42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04884399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.

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