A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration

NCT07798375 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: VIS-101-CL-202
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Neovascular Age Related Macular Degeneration(nAMD)

Keywords

age related macular degeneration; choroidal neovascularization; wet age related macular degeneration

Outcome Measures

Primary Outcomes (1)

• 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

  From Baseline through Week 28

Secondary Outcomes (12)

• 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

Study Arms (4)

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.

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.

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.

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).

Biological: Aflibercept (Eylea)

Interventions

VIS-101 6.0mg Low concentration BIOLOGICAL

VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.

VIS-101 6.0mg Low concentration

VIS-101 6.0mg High concentration BIOLOGICAL

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 concentration

VIS-101 9.0mg High concentration BIOLOGICAL

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 concentration

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).

Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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
• \. Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid
• \. 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
• \. Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG laser capsulotomy within 3 months before Day 0
• \. Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy)

Sponsors & Collaborators

• Everest Medicines (China) Co.,Ltd.: lead
• Visara, Inc.: collaborator

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trial Information Center, Everest Medicines

CONTACT

+8621-80125712; ctinfo.center@everestmedicines.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, quadruple masked, active controlled parallel group design.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-08