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

ConditionNeovascular Age Related Macular Degeneration(nAMD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorEverest Medicines (China) Co.,Ltd.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • VIS-101 6.0mg Low concentration

    Biological/Vaccine

    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

    Biological/Vaccine

    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

    Biological/Vaccine

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

  • Aflibercept (Eylea)

    Biological/Vaccine

    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).

Treatment groups

244 Participants
are divided into 4 treatment groups
Group A: VIS-101 6.0mg Low concentrationExperimental treatment 1 intervention
Group B: VIS-101 6.0mg High concentrationExperimental treatment 1 intervention
Group C: VIS-101 9.0mg High concentrationExperimental treatment 1 intervention
Group D: AfliberceptActive comparator 1 intervention

Trial outcomes

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

Time frame
From Baseline through Week 28

Secondary outcomes

1

Change in BCVA from baseline

Time frame
Throughout week 48
2

Dosing interval

Time frame
Throughout week 48
3

Number of injections

Time frame
Throughout week 44
4

Change in CST from baseline

Time frame
Throughout week 28 and week 48

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Everest Medicines (China) Co.,Ltd.

Lead sponsor

Visara, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: