NL-OMON48627CompletedPhase 3
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 Degeneration - KHB-1801 Conbercept in Subjects with *wet* AMD
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 28
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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;, 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).
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
- •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
- •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;
Investigators
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