Pathological Myopic Choroidal Neovascularization
Conditions
Keywords
VEGF; pmCNV; antibody
Brief summary
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to pmCNV
Detailed description
Following a 14-day maximum screening period, patients will be randomized and followed for approximately 36 weeks. Treatment visits will be scheduled in 4-week intervals. After 1 initial injection of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 4 to week 32). During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.
Interventions
DRUG601
intravitreal recombinant humanized anti-VEGF monoclonal antibody
DRUGRanibizumab
intravitreal recombinant humanized anti-VEGF monoclonal antibody
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign informed consent form and willing to be visited at the time specified in the trial * Male or Female, at least 18 years of age * The study eye must meet the following criteria * Diagnosed with active choroidal neovascularization secondary to pathological myopia * BCVA score between 78 and 24 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) * No optometric media opacity and pupil abnormal * BCVA score ≥ 34 letters in the fellow eye, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/200)
Exclusion criteria
* CNV secondary to other causes (except pathological myopia), such as neovascularage-related macular degeneration (nAMD), polypoid choroidal vascular disease (PCV), and secondary injury * The fovea has fibrosis and organochemical foci or scar or atrophy that obviously involves the fovea and causes irreversible vision loss; * Previous use of intraocular or periocular steroids within 3 months prior to baseline, or previous use of dexamethasone intravitreal implant within 6 months prior to enrollment; * PDT, Macular laser photocoagulation (focal/grid), vitrectomy or keratoplasty in the study eye at any time prior to baseline. Panretinal laser photocoagulation，YAG laser treatment or any other ocular surgeries (e.g. cataract surgery ) in the study eye within 3 months prior to the baseline * Aphakia (except IOL) or posterior capsular defect (except YAG posterior capsulotomy after intraocular lens implantation surgery) For Any Eye: * Any eye has active ocular infections (e.g. blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) * History of intravitreal use of anti-VEGF drugs (e.g. ranibizumab，bevacizumab，aflibercept, conbercept, etc.) in any eye within 3 months prior to baseline General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in best-corrected visual acuity (BCVA) at Week 12 | Baseline to Week 12 | Assessed with ETDRS visual acuity testing charts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in central retina thickness (CRT) on each visit | Baseline to Week 36 | OCT (optical coherence tomography) was used to assess central retina thickness (CRT) representing the average retinal thickness of the central 1 mm diameter subfield around the foveal center. |
| Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA on each visit compared to baseline | Baseline to Week 36 | Assessed with ETDRS visual acuity testing charts. |
| Number of injections from Week 4 to Week 36 | Week 4 to Week 36 | Number of administered injections |
| Average Change of BCVA on each visit compared to baseline. | Baseline to Week 36 | Assessed with ETDRS visual acuity testing charts. |
| Blood concentrations of 601 | Baseline, Week 4, Week 12, Week 24 and Week 36. | Steady-state blood concentrations of 601 |
| Blood concentrations of VEGF | Baseline, Week 4, Week 12, Week 24 and Week 36. | Detection of VEGF blood concentration |
| Immunogenicity of 601 | Baseline, Week 4, Week 12, Week 24 and Week 36. | Detection of blood Anti-drug antibody (ADA) status. If ADA was positive, Neutralization antibody (Nab) will be tested |
| Incidence of ocular and non-ocular AEs up to Week 36 | Baseline to Week 36 | Incidence of ocular and non-ocular AEs |
Countries
China
Contacts
Primary ContactYouXin Chen, PhD
Outcome results
None listed