ClinicalTrials.gg
Not yet recruitingNCT07798375ASCENDUpdated Nov 5, 2026

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

A Phase 2 interventional study of VIS-101 6.0mg Low concentration and VIS-101 6.0mg High concentration in Neovascular Age Related Macular Degeneration(nAMD), sponsored by Everest Medicines (China) Co.,Ltd.. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Everest Medicines (China) Co.,Ltd. · Phase 2, Interventional, and Treatment

Updated Nov 5, 2026Start date movedPrimary completion moved+3 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
244
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Neovascular Age Related Macular Degeneration(nAMD)

Keywords

  • age related macular degeneration
  • choroidal neovascularization
  • wet age related macular degeneration
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's planned enrollment of 244 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Everest Medicines (China) Co.,Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 5, 2026. See what changed

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Willingness to sign the 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 (WOCBP) or male participants with partners who are WOCBP must agree to use highly effective 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

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 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 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 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, , 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 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.

22. Known hypersensitivity to any component of faricimab injection

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
244 participants (estimated)

Study arms

  • Experimental
    VIS-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.

    Biological: VIS-101 6.0mg Low concentration

  • Experimental
    VIS-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.

    Biological: VIS-101 6.0mg High concentration

  • Experimental
    VIS-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.

    Biological: VIS-101 9.0mg High concentration

  • Active comparator
    Aflibercept

    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

  • 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.

  • 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).

06

What researchers measure

Primary outcomes

  1. Change in BCVA from baseline to Week 36

    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

    Time frame: From Baseline through Week 36

Secondary outcomes

  1. Change in BCVA from baseline

    Time frame: Throughout week 36

  2. Dosing interval

    Time frame: Throughout week 32

  3. Number of injections

    Time frame: Throughout week 32

  4. Change in CST from baseline

    Time frame: Throughout week 36

  5. Proportion of participants with no intraretinal fluid

    Time frame: Throughout week36

  6. Proportion of participants with no subretinal fluid

    Time frame: Throughout week36

  7. Proportion of participants with no intraretinal and subretinal fluid

    Time frame: Throughout week36

  8. Proportion of participants with no intraretinal cysts

    Time frame: Throughout week36

  9. Proportion of participants with no retinal pigment epithelial (RPE) detachment

    Time frame: Throughout week36

  10. Change in total area of CNV lesion from baseline

    Time frame: Throughout week 36

  11. Change in total leakage area from baseline

    Time frame: Throughout week 36

  12. Incidence and severity of post-treatment adverse events, treatment-related adverse events and serious adverse events

    Time frame: Throughout week36

  13. Number of supplemental study treatment injections received

    Time frame: Throughout week32

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — To be determined

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jul 2028, 20 months later.

Of 66 industry-sponsored phase 2 interventional studies under Macular Degeneration, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's planned 20 months is below that.

Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 16 and three quarters within 35.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Sep 2026 → Nov 2026, primary completion May 2028 → Jul 2028 and completion Oct 2028 → Dec 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 1, 2026
StartEst.
Nov 2026was Sep 2026
Primary completionEst.
Jul 2028was May 2028
CompletionEst.
Dec 2028was Oct 2028
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 2026→Nov 2026
Nov 5, 2026
Primary completion
May 2028→Jul 2028
Nov 5, 2026
Study completion
Oct 2028→Dec 2028
Nov 5, 2026
Eligibility
1 exclusion criterion added
What changed in the criteria
Exclusion criteria
  • Added22. Known hypersensitivity to any component of faricimab injection
Nov 5, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedChange in BCVA from baseline to average of Weeks 20, 24, and 28Week 36Time frame: From Baseline through Week 28 → From Baseline through Week 36
Nov 5, 2026
Secondary outcomes
12 time frame changed, 1 added
What changed in the outcomes
  • AddedNumber of supplemental study treatment injections receivedTime frame: Throughout week32
  • Time frameChange in BCVA from baselineThroughout week 48 → Throughout week 36
  • Time frameDosing intervalThroughout week 48 → Throughout week 32
  • Time frameNumber of injectionsThroughout week 44 → Throughout week 32
  • Time frameChange in CST from baselineThroughout week 28 and week 48 → Throughout week 36
  • Time frameProportion of participants with no intraretinal fluidThroughout week48 → Throughout week36
  • Time frameProportion of participants with no subretinal fluidThroughout week48 → Throughout week36
  • Time frameProportion of participants with no intraretinal and subretinal fluidThroughout week48 → Throughout week36
  • Time frameProportion of participants with no intraretinal cystsThroughout week48 → Throughout week36
  • Time frameProportion of participants with no retinal pigment epithelial (RPE) detachmentThroughout week48 → Throughout week36
  • Time frameChange in total area of CNV lesion from baselineThroughout week 28 and 48 → Throughout week 36
  • Time frameChange in total leakage area from baselineThroughout week 28 and 48 → Throughout week 36
  • Time frameIncidence and severity of post-treatment adverse events, treatment-related adverse events and serious adverse eventsThroughout week48 → Throughout week36
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Start date Sep 2026→Nov 2026
    Primary completion May 2028→Jul 2028
    Study completion Oct 2028→Dec 2028
    Eligibility 1 exclusion criterion added
    What changed in the criteria
    Exclusion criteria
    • Added22. Known hypersensitivity to any component of faricimab injection
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedChange in BCVA from baseline to average of Weeks 20, 24, and 28Week 36Time frame: From Baseline through Week 28 → From Baseline through Week 36
    Secondary outcomes 12 time frame changed, 1 added
    What changed in the outcomes
    • AddedNumber of supplemental study treatment injections receivedTime frame: Throughout week32
    • Time frameChange in BCVA from baselineThroughout week 48 → Throughout week 36
    • Time frameDosing intervalThroughout week 48 → Throughout week 32
    • Time frameNumber of injectionsThroughout week 44 → Throughout week 32
    • Time frameChange in CST from baselineThroughout week 28 and week 48 → Throughout week 36
    • Time frameProportion of participants with no intraretinal fluidThroughout week48 → Throughout week36
    • Time frameProportion of participants with no subretinal fluidThroughout week48 → Throughout week36
    • Time frameProportion of participants with no intraretinal and subretinal fluidThroughout week48 → Throughout week36
    • Time frameProportion of participants with no intraretinal cystsThroughout week48 → Throughout week36
    • Time frameProportion of participants with no retinal pigment epithelial (RPE) detachmentThroughout week48 → Throughout week36
    • Time frameChange in total area of CNV lesion from baselineThroughout week 28 and 48 → Throughout week 36
    • Time frameChange in total leakage area from baselineThroughout week 28 and 48 → Throughout week 36
    • Time frameIncidence and severity of post-treatment adverse events, treatment-related adverse events and serious adverse eventsThroughout week48 → Throughout week36
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07798375
Lead sponsor
Everest Medicines (China) Co.,Ltd.
Collaborators
Visara, Inc.
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Clinical Trial Information Center, Everest Medicines
Contact
ctinfo.center@everestmedicines.com
+8621-80125712

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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