JY028 Single Vitreous Injection in a Phase 1 Clinical Trial in nAMD Patients

NCT03725566 | Unknown

• 1 other identifier: 2017L02087
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I clinical trial on safety, tolerance, pharmacokinetics (PK) and pharmacodynamics of recombinant human anti-VEGF monoclonal antibody injection in patients with neovascular (wet) age-related macular degeneration

Conditions

Macular Degeneration

Keywords

New vascular macular degeneration

Outcome Measures

Primary Outcomes (1)

• JY028 related incidence of ocular and systemic adverse events and serious adverse events

  JY028 related incidence of ocular and systemic adverse events and serious adverse events

  13 weeks

Secondary Outcomes (4)

• Cmax

  13 weeks

• Tmax

  13 weeks

• BCVA

  13 weeks

• AUC0-t、AUCinf

  13 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;

Drug: Experimental

Interventions

Experimental DRUG

Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;

Also known as: intravitreous injection

Experimental

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The patient volunteered to participate and signed the informed consent 2. No more than 50 years of age and less than 75 years of age, male or female 3. Diagnosed as nAMD 4. The optimal corrected visual acuity of the target eye ETDRS should be no more than 50 letters, and the optimal corrected visual acuity of the opposite eye should be no more than 34 letters 5. The target eye pressure is no more than 25mmHg, which can be controlled by drugs 6. A normal coagulation function: the platelet count is 100 x 10 \^ 9-300x 10\^10 / L, thrombin time, prothrombin time within the normal range.

You may not qualify if:

• Choroid polypoid angiopathy (PCV)
• There are other obvious eye diseases/conditions (such as diabetic retinopathy, cataract, abnormal eyelid, uncontrolled glaucoma, eye active inflammation, etc.)
• CNV caused by other causes other than nAMD, such as diabetic retinopathy, vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc
• The target eye has received any intraocular surgery or laser therapy within 3 months prior to enrollment
• Any eye treated with antiangiogenic drugs within 3 months prior to baseline visit
• Patients with active eye infections, such as conjunctivitis, keratitis, sclerotic, blepharitis, endophthalmitis or uveitis
• Persons with a history of myocardial infarction and/or cerebral infarction or other active or acute cardiovascular diseases
• HIV antibody/hiv-p24 antigen, any of the positive subjects in the treponema pallidum antibody
• Active HBsAg carriers (conditions must be met: HBsAg positive, HBV DNA positive, ALT higher than normal upper limit)
• Patients with HCV (the following conditions must be met: lgM positive anti-hcv antibody, ALT higher than the upper limit of normal value)
• Fluorescein sodium allergy
• Allergy to anti-vegf monoclonal antibodies or humanized monoclonal antibodies
• Patients who participated in other clinical trials within 3 months
• Patients who took NSAIDs and aspirin or other anticoagulant or platelet drugs within 1 month before enrollment
• An unhealed wound, ulcer, fracture, or other related medical condition

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• xiu li zhao, doctor

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 31, 2018
• Study Start: May 22, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 31, 2018

Record last verified: 2018-09

Locations

CN (1)