Neovascular Age Related Macular Degeneration(nAMD)
Conditions
Keywords
age related macular degeneration, choroidal neovascularization, wet age related macular degeneration
Brief summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of VIS-101 administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD)
Interventions
BIOLOGICALVIS-101 6.0mg Low concentration
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
BIOLOGICALVIS-101 6.0mg High concentration
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
BIOLOGICALVIS-101 9.0mg High concentration
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
BIOLOGICALAflibercept (Eylea)
Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
Sponsors
Everest Medicines (China) Co.,Ltd.
Visara, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, quadruple masked, active controlled parallel group design.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willingness to sign the informed consent form, aged ≥50 years (on Day 0 of dosing), with no gender restrictions 2. Able to adhere to the study protocol per the Investigator judgment 3. Female participants of childbearing potential (WOCBP) or male participants with partners who are WOCBP must agree to use highly effective contraception from screening until 3 months after treatment completion 4. Treatment-naïve CNV secondary to AMD (nAMD) 5. Subfoveal CNV or juxtafoveal/extrafoveal CNV with a subfoveal component related to the CNV activity identified by FFA or OCT (where CNV activity is defined as showing evidence of subretinal fluid, subretinal hyperreflective material, or leakage) confirmed by the Central Reading Center 6. Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good-quality retinal images to confirm diagnosis and follow up
Exclusion criteria
1. Any major illness or major surgical procedure within 1 month before screening in the opinion of the investigator 2. Active cancer within the past 12 months before screening except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score ≤6 and a stable prostate-specific antigen for \>12 months 3. Requirement for continuous use of any medications and treatments indicated as prohibited therapy 4. Systemic treatment for suspected or active systemic infection on Day 0 Ongoing use of prophylactic antibiotic therapy may be acceptable if approved after discussion with the medical monitor 5. Uncontrolled blood pressure, defined as systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg whilst a participant is at rest on Day 0 6. Stroke (cerebral vascular accident) or myocardial infarction within 6 months before Day 0 7. History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator 8. Pregnancy or breastfeeding, or intention to become pregnant during the study WOCBP must have a negative serum pregnancy test result within 28 days before initiation of study treatment. 9. History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of VIS-101, aflibercept, study-related procedure preparations (including fluorescein and indocyanine green), dilating drops, or any of the anesthetic and anti-microbial drops used by the participant during the study 10. Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals) within 3 months before Day 0 11 Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment (e.g., anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or ocular surgical intervention 12\. Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid 13\. Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study 14\. Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG laser capsulotomy within 3 months before Day 0 15\. Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy) 16\. Previous periocular pharmacological or IVT treatment (including anti VEGF and/or anti VEGF/ANG2 medications) for other retinal diseases 17\. BCVA of hand motion or worse in the fellow eye 18\. Monocular (no fellow eye) 19\. Any history of idiopathic or autoimmune associated uveitis in either eye 20\. Active ocular inflammation or suspected or active ocular or periocular infection in either eye on Day 0 21 Aphakic lens status or anterior chamber intraocular lens or an absence of the posterior lens capsule. Previous violation of the posterior capsule is also an exclusion criterion unless it occurred due to prior laser capsulotomy in association with a prior in the bag lens implantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BCVA from baseline to average of Weeks 20, 24, and 28 | From Baseline through Week 28 | BCVA as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity |
Secondary
| Measure | Time frame |
|---|---|
| Change in BCVA from baseline | Throughout week 48 |
| Dosing interval | Throughout week 48 |
| Number of injections | Throughout week 44 |
| Change in CST from baseline | Throughout week 28 and week 48 |
| Proportion of participants with no intraretinal fluid | Throughout week48 |
| Proportion of participants with no subretinal fluid | Throughout week48 |
| Proportion of participants with no intraretinal and subretinal fluid | Throughout week48 |
| Proportion of participants with no intraretinal cysts | Throughout week48 |
| Proportion of participants with no retinal pigment epithelial (RPE) detachment | Throughout week48 |
| Change in total area of CNV lesion from baseline | Throughout week 28 and 48 |
| Change in total leakage area from baseline | Throughout week 28 and 48 |
| Incidence and severity of post-treatment adverse events, treatment-related adverse events and serious adverse events | Throughout week48 |
Contacts
CONTACTClinical Trial Information Center, Everest Medicines
Outcome results
None listed