Age-Related Macular Degeneration (AMD)

The primary objective is to determine if 0.5 mg or 1.0 mg conbercept is non-inferior to aflibercept 2.0 mg in subjects with neovascular AMD as measured by the change from baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) letter score at Week 36.

Conbercept

Conbercept

injection

0.5 or 1.0 mg

Primary Outcome Measures :
Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye [ Time Frame: Baseline to Week 36 ]
BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method

Inclusion Criteria
Each subject must meet the following 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;
o 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 BCVA ETDRS 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)

Exclusion Criteria
Each subject may NOT:
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 antiglaucoma 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 concurrent ocular condition in the study eye that, in the opinion of the
Investigator, could either increase the risk to the subject beyond what is to be
expected from standard procedures of intraocular injection, or that otherwise may
interfere with the injection procedure or with evaluation of efficacy or safety
during the study;
23. Have any evidence by medical history, physical examination or clinical laboratory
testing at Screening or Baseline that shows reasonable suspicion of a disease or
condition that contraindicates the use of study medication (conbercept or
aflibercept) or that might affect interpretation of the results of the study or render
the subject at high risk for treatment complications;
24. Have any use of long acting intraocular steroids, including implants, within six
months prior to Day 1, Baseline;
25. Have any known allergy to povidone iodine or known serious allergy to the
fluorescein sodium for injection in angiography;
26. Any history of known contraindications indicated in the Food and Drug
Administration (FDA)-approved label for the active control;
27. If female, be pregnant (positive urine pregnancy test at Screening) or
breastfeeding