NCT04151407

Brief Summary

Observe the safety and tolerability of the single and multiple doses of 601 in DME patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections with different doses in the treatment of patients with DME.

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
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

4 active sites

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

March 8, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 5, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

October 31, 2019

Last Update Submit

October 31, 2019

Conditions

Diabetic Macular Edema

Keywords

VEGF; DME; bevacizumab; safety

Outcome Measures

Primary Outcomes (2)

  • DLT

    Incidence of dose-limiting toxicities up to the Day 28

    From Day 0 up to Day 28

  • MTD

    Maximum tolerated dose

    From Day 0 up to Day 56/112.

Secondary Outcomes (9)

  • 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

  • CL

    From Day 0 up to 56/112 days

  • +4 more secondary outcomes

Study Arms (7)

601 dose level 1 treatment

EXPERIMENTAL

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

Drug: Drug 601

601 dose level 2 treatment

EXPERIMENTAL

Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg), Vitreous injection, injection once

Drug: Drug 601

601 dose level 3 treatment

EXPERIMENTAL

Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once

Drug: Drug 601

601 dose level 4 treatment

EXPERIMENTAL

Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once;

Drug: Drug 601

601 dose level 5 treatment

EXPERIMENTAL

Recombinant humanized anti-VEGF monoclonal antibody, drug 601(3.75mg), Vitreous injection, injection once;

Drug: Drug 601

601 dose level 6 treatment

EXPERIMENTAL

Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once every 4 weeks, three times continuously.

Drug: Drug 601

601 dose level 7 treatment

EXPERIMENTAL

Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once every 4 weeks, three times continuously.

Drug: Drug 601

Interventions

Drug 601DRUG

Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.

601 dose level 1 treatment601 dose level 2 treatment601 dose level 3 treatment601 dose level 4 treatment601 dose level 5 treatment601 dose level 6 treatment601 dose level 7 treatment

Eligibility Criteria

Age18 Years - 75 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 \>= 18 years and age =\< 75 years
  • Diagnosis of type 1 or type 2 diabetes
  • Hemoglobin (HbA1c) value =\< 11%
  • The study eye must meet the following criteria
  • Diabetic macular edema with central fovea involvement and visual impairment in subjects;
  • Best corrected visual acuity letter score (ETDRS)\>= 19 (i.e., 20/400 or better) and \<= 73 (i.e., 20/40 or worse)in the study eye;
  • CRT ≥ 275 μm;
  • No optometric media opacity and pupil shrinkage.
  • Best corrected visual acuity letter score (ETDRS) \> =24 (i.e., 20/320 or better)in the fellow eyes

You may not qualify if:

  • Any eye has active ocular infections (e.g.,blepharitis, keratitis, scleritis, conjunctivitis);
  • The study eye has proliferative diabetic retinopathy (PDR), except for the PDR with regression after panretinal photocoagulation, and Inactive, fibrotic PDR
  • History of vitreous hemorrhage in the study eye within 2 months before screening
  • Structural retinal damage with fovea in the study eye (e.g. retinal pigment epithelium(RPE) atrophy, retinal fibrosis, laser scarring, dense hard exudation), or researchers believe that the study eye has other retinal damage that may hinder visual improvement after macular edema subsides
  • In addition to diabetic retinopathy, there are other causes of macular edema or visual changes in the study eye.
  • Ophthalmic conditions (e.g.,retinal vein occlusion (RVO) Choroidal neovascularization, retinal detachment, macular hole, retinal traction in macular region, epiretinal membrane, etc.)
  • Iris neovascularization in the study eye;
  • Uncontrollable glaucoma in the study eye (defined as intraocular pressure after antiglaucoma medication\>= 25 mm Hg), or glaucoma filtering surgery history;
  • Researchers believe that cataract in the study eye may affect the judgement of examination or test results, or surgical treatment is required in 6 months following screening
  • The study eye has no lens( except intraocular lens)
  • History of Intraocular injection for corticosteroids (e.g. triamcinolone) at any time in the past 3 months, or corticosteroids injection around the eyes within one month before screening
  • History of vitrectomy in the studyeye
  • History of panretinal photocoagulation in the study eye in the past 6 months before screening; or panretinal photocoagulation may be required following screening
  • Study eye have received more than two local/grid retinal photocoagulation treatments, or history of local/grid retinal photocoagulation treatments in the study eye in the past 3 months before screening
  • History of anti-VEGF drugs treatments(e.g. Abercept, Pigatani Sodium, Razumab, Bevacizumab, etc.) in any eye or system within 3 months before screening;
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chinese PLA General Hospital of Central Theater.

Wuhan, Hubei, 430000, China

RECRUITING

JiangSu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Central Study Contacts

Xiaodong Sun, PhD

CONTACT

+86-021-36216424xdsun@sjtu.edu.cn

Fenghua Wang, Doctor

CONTACT

+86-021-36216424smilefh@126.com

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

October 31, 2019

First Posted

November 5, 2019

Study Start

March 8, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)