A multicenter, double-blinded, randomized, different doses study to evaluate the efficacy and safety of Conbercept injection in patients with Neovascular Age related Macular Degeneratio

Phase 1

• Conditions: eovascular Age Related Macular Degeneration; MedDRA version: 20.1Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-004826-14-LV
• Lead Sponsor: Chengdu Kanghong Biotechnology Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-28
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1140

Inclusion Criteria

1.Men and women = 50 years of age at the Screening visit;

2.Females must be at least 1 year postmenopausal, or surgically sterilized, or, if of childbearing potential, must have a negative pregnancy test at the Screening visit;

Women of childbearing potential must agree to use a highly effective method of contraception throughout the study (See complete list in the Study Procedures Manual);

3.Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and;

4.Have active subfoveal CNV lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal FA leakage, or definite subfoveal fluid by SD-OCT in the study eye at Screening;

5.Have CNV that is at least 50% of total lesion size in the study eye at Screening;

6.Have a ETDRS BCVA letter score of 78 to 25 (approximately 20/32 to 20/320 equivalent) in the study eye at Screening;

7.Have ocular media (lens, cornea, vitreous) of adequate clarity to permit high quality fundus imaging;

8.Are willing and able to sign the study written informed consent form (ICF).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

1.Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD in the study eye except dietary supplements or vitamins;
2.Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit;
3.Have a total lesion size greater than twelve disc areas (30.5 mm2), including blood, fibrosis and neovascularization, as assessed by FA in the study eye at Screening;
4.Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is under the fovea and is one or more disc areas in size (greater than 2.5 mm2) in the study eye at Screening;
5.Have scarring or fibrosis making up greater than 50% of total lesion in the study eye at Screening; and/or scarring, fibrosis or atrophy involving the center of the fovea in the study eye at Screening;
6.Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline;
7.Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening;
8.Have any other cause of CNV, including pathologic myopia (defined per protocol as spherical equivalent of -8 diopters or more), ocular histoplasmosis syndrome, angioid streaks, inherited macular dystrophies, choroidal rupture, uveitis, punctate inner choroidopathy, or multifocal choroiditis in the study eye at Screening;
9.Have a history of or clinical evidence of significant diabetic retinopathy that could impact assessment of vision or affect central vision, diabetic macular edema, or any other vascular disease other than AMD including history or clinical evidence of retinal vein occlusion affecting the study eye at Screening;
10.Have had prior pars plana vitrectomy in the study eye;
11.Have presence of a full thickness macular hole at Screening or upon examination at Baseline or a history of a full thickness macular hole in the study eye;
12.Have a history of intraocular or periocular surgery within three months of Baseline in the study eye, except in the case of lid surgery, which may not have taken place within one month of Baseline as long as it is unlikely to interfere with IVT injection;
13.Have prior trabeculectomy or other filtration surgery in the study eye;
14.Have uncontrolled glaucoma (defined as intraocular pressure (IOP) greater than or equal to 22 mmHg at Baseline despite treatment with more than two anti-glaucoma medications) in the study eye;
15.Have active intraocular inflammation in either eye at Screening or upon examination at Baseline or a history of uveitis in either eye;
16.Have active ocular or periocular infection in either eye, or a history of any ocular or periocular infection within the two weeks prior to Screening in either eye;
17.Have presence or history of scleromalacia in either eye;
18.Have aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye;
19.Have had previous therapeutic radiation in the region of the study eye;
20.Have history of corneal transplant or presence of a corneal dystrophy that interferes with IOP measurements or imaging in the study eye;
21.Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study period;
22.Have any concurre

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified