A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age related Macular Degeneratio
- Conditions
- Neovascular Age Related Macular Degenerationwet AMD10015919
- Registration Number
- NL-OMON48627
- Lead Sponsor
- Chengdu Kanghong Biotechnology Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
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 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).
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;
2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to determine if 0.5 mg or 1.0 mg conbercept is<br /><br>non-inferior to aflibercept 2.0 mg as measured by the change from baseline in<br /><br>best corrected visual acuity (BCVA) by Early Treatment of Diabetic Retinopathy<br /><br>Study (ETDRS) method at the Week 36 visit.<br /><br>The primary endpoint is the mean change from baseline in ETDRS BCVA letter<br /><br>score at Week 36 in the study eye.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives of this study are:<br /><br><br /><br>1. To evaluate the difference in efficacy between conbercept doses and<br /><br>aflibercept, with respect to the following:<br /><br>* Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA<br /><br>letters) from baseline to Week 36;<br /><br>* Proportion of subjects gaining *15 ETDRS BCVA letters from baseline to Week<br /><br>36;<br /><br>* Mean change from baseline in central retinal thickness (µm) by SD-OCT at Week<br /><br>36;<br /><br>* Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA<br /><br>letters) from baseline to Week 48;<br /><br>* Mean change from baseline in ETDRS BCVA letter score at Week 96<br /><br><br /><br>2. To compare the safety and tolerability of conbercept doses and aflibercept,<br /><br>and to evaluate the pharmacokinetics and immunogenicity of conbercept doses,<br /><br>when feasible</p><br>