Neovascular Age Related Macular Degeneration(nAMD)Phase 2ASCENDNCT07798375
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
A Phase 2 study testing VIS-101 6.0mg Low concentration, VIS-101 6.0mg High concentration and VIS-101 9.0mg High concentration in people with Neovascular Age Related Macular Degeneration(nAMD), run by Everest Medicines (China) Co.,Ltd..
Trial 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) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age Related Macular Degeneration(nAMD)
- What is being tested?
- VIS-101 6.0mg Low concentration, VIS-101 6.0mg High concentration and VIS-101 9.0mg High concentration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to sign the informed consent form, aged ≥50 years (on Day 0 of dosing), with no gender restrictions
- Able to adhere to the study protocol per the Investigator judgment
- 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
- Treatment-naïve CNV secondary to AMD (nAMD)
- 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
- Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good-quality retinal images to confirm diagnosis and follow up
Who cannot join
- Any major illness or major surgical procedure within 1 month before screening in the opinion of the investigator
- 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
- Requirement for continuous use of any medications and treatments indicated as prohibited therapy
- 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
- 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
- Stroke (cerebral vascular accident) or myocardial infarction within 6 months before Day 0
Show all 21Show fewer
- 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
- 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.
- 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
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Clinical Trial Information Center, Everest Medicines contact
About this study
Official title: A Multicenter, Randomized, Quadruple-Masked, Active-Controlled Phase 2b Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of VIS-101 Intravitreal Injection in Treatment- Naïve Participants With Neovascular Age-Related Macular Degeneration
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)
- Being tested
- VIS-101 6.0mg Low concentration, VIS-101 6.0mg High concentration, VIS-101 9.0mg High concentration, Aflibercept (Eylea)
- Keywords
- age related macular degeneration, choroidal neovascularization, wet age related macular degeneration
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIS-101 6.0mg Low concentrationBiological
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
VIS-101 6.0mg High concentrationBiological
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
VIS-101 9.0mg High concentrationBiological
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
Aflibercept (Eylea)Biological
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).
| Study group | Role | What they receive |
|---|---|---|
| VIS-101 6.0mg Low concentration | Experimental | VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol. Receives: Biological: VIS-101 6.0mg Low concentration |
| VIS-101 6.0mg High concentration | Experimental | VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol. Receives: Biological: VIS-101 6.0mg High concentration |
| VIS-101 9.0mg High concentration | Experimental | VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol. Receives: Biological: VIS-101 9.0mg High concentration |
| Aflibercept | Active comparator | 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). Receives: Biological: Aflibercept (Eylea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BCVA from baseline to average of Weeks 20, 24, and 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
Measured: From Baseline through Week 28
Secondary outcomes (12)
Change in BCVA from baseline
Measured: Throughout week 48
Dosing interval
Measured: Throughout week 48
Number of injections
Measured: Throughout week 44
Change in CST from baseline
Measured: Throughout week 28 and week 48
Proportion of participants with no intraretinal fluid
Measured: Throughout week48
Proportion of participants with no subretinal fluid
Measured: Throughout week48
Proportion of participants with no intraretinal and subretinal fluid
Measured: Throughout week48
Proportion of participants with no intraretinal cysts
Measured: Throughout week48
Proportion of participants with no retinal pigment epithelial (RPE) detachment
Measured: Throughout week48
Change in total area of CNV lesion from baseline
Measured: Throughout week 28 and 48
Change in total leakage area from baseline
Measured: Throughout week 28 and 48
Incidence and severity of post-treatment adverse events, treatment-related adverse events and serious adverse events
Measured: Throughout week48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age Related Macular Degeneration(nAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, quadruple masked, active controlled parallel group design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Everest Medicines (China) Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Visara, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798375
- Sponsor's protocol ID
- VIS-101-CL-202
- Acronym
- ASCEND
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined