NCT04468997

Brief Summary

Multicenter study to evaluate the safety and tolerability in patients with wet Age-related macular degeneration (wAMD) treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

July 8, 2020

Last Update Submit

July 8, 2020

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

  • DLT

    Incidence of dose-limiting toxicities up to the Day 14 visit

    From Day 0 up to Day 14

  • MTD

    Maximum tolerated dose

    From Day 0 up to Day 56/112.

Secondary Outcomes (12)

  • Pharmacokinetic (PK) profile

    From Day 0 up to 56/112 days

  • Cmax

    From Day 0 up to 56/112 days

  • t1/2

    From Day 0 up to 56/112 days

  • AUC

    From Day 0 up to 56/112 days

  • Vd

    From Day 0 up to 56/112 days

  • +7 more secondary outcomes

Study Arms (6)

601 dose level 1 treatment

EXPERIMENTAL
Drug: Drug 601

601 dose level 2 treatment

EXPERIMENTAL
Drug: Drug 601

601 dose level 3 treatment

EXPERIMENTAL
Drug: Drug 601

601 dose level 4 treatment

EXPERIMENTAL
Drug: Drug 601

601 dose level 5 treatment

EXPERIMENTAL
Drug: Drug 601

601 dose level 6 treatment

EXPERIMENTAL
Drug: Drug 601

Interventions

Drug 601DRUG

Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg), Vitreous injection, injection once;

601 dose level 1 treatment

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sign informed consent form and willing to be visited at the time specified in the trial;
  • Age ≥45 years and age ≤ 80 years;
  • The study eye must meet the following criteria:
  • Diagnosis of wAMD;
  • The presence of an primary or recurrent active choroidal neovascular (CNV) lesions in subfovea and para-fovea secondary to AMD;
  • Total area of all types of lesions ≤30mm2 (12 optic disc areas)
  • Best EDTRS letter score between 19 and 78(Snellen equivalent of 20/400 to 20/32);
  • No optometric media opacity and pupil shrinkage.
  • Best EDTRS letter score ≥19 (Snellen equivalent of 20/400 or better) in the fellow eyes.

You may not qualify if:

  • Any of the following eye conditions:
  • Any eye has active ocular infections (e.g.,blepharitis, keratitis, scleritis, conjunctivitis);
  • History of vitreous hemorrhage in the study eye within 2 months before screening;
  • scarring, fibrosis, or atrophy below with fovea in the study eye;
  • Received any drug treatment for CNV within 120 days prior to screening;
  • History of any following surgery in the study eye (e.g. PDT, macular transposition, Glaucoma filtration, subfoveal photocoagulation, vitrectomy and transpupular hyperthermia, and other surgery at the submacular or others for AMD) within 3 months before screening;
  • CNV in the study eye associated with other ocular diseases such as pathologic myopia, eye trauma, etc
  • History or present of uncontrolled glaucoma, history of glaucoma filtering surgery in the study eye;
  • Subretinal hemorrhage in the study eye, and the bleeding area ≥ 50% area of the total lesion;
  • History of rhegmatogenous retinal detachment or macular hole retinal detachment (stage 3 or 4) , retinal detachment, retinal pigment epithelium tear or macular area traction and macular area preretinal membrane and PCV in the study eye;
  • The study eye has no lens( except intraocular lens) or posterior capsular rupture of the lens;
  • Any of the following general condition are present:
  • Medicines with toxicity to the lens are being used or may be used during the study period;
  • History of allergy to fluorescein sodium and allergies to protein products for treatment or diagnosis, history of allergy to more than two drugs and/or non-drug factors, or suffering from allergic diseases now.
  • History of surgery within 1 months before screening; and/or unhealed wounds, ulcers or fractures currently;
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BeiJing Hospital

Beijing, China

RECRUITING

Central Study Contacts

Zhang Ming, Ph.D

CONTACT

+86-028-85422452zhangmingscu@126.com

Lu Fang

CONTACT

+86-028-85422452lufang@medicail.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 13, 2020

Study Start

November 12, 2018

Primary Completion

March 15, 2021

Study Completion

September 15, 2021

Last Updated

July 13, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)