A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis

NCT06679153 | Completed Phase 2 DMC

• 1 other identifier: VVN461-CCS-201
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis

Conditions

Anterior Uveitis

Outcome Measures

Primary Outcomes (1)

• ACC score of ≥2 grade from baseline at Day 14

  Proportion of subjects with improvement in ACC score of ≥2 grade from baseline at Day 14

  Day 14

Secondary Outcomes (1)

• ACC score of 0

  Baseline to Day 28

Study Arms (3)

VVN461, 1.0%

EXPERIMENTAL

VVN461 Ophthalmic Solution, 1.0%

Drug: VVN461 Ophthalmic Solution 1.0%

VVN461, 0.5%

EXPERIMENTAL

VVN461 Ophthalmic Solution, 0.5%

Drug: VVN461 Ophthalmic Solution 0.5%

Prednisolone acetate, 1%

PLACEBO COMPARATOR

Prednisolone acetate Ophthalmic Solution, 1%

Drug: Prednisolone acetate

Interventions

VVN461 Ophthalmic Solution 1.0% DRUG

VVN461 Ophthalmic Solution, 1.0%, for up to 28 days

VVN461, 1.0%

VVN461 Ophthalmic Solution 0.5% DRUG

VVN461 Ophthalmic Solution, 0.5%, for up to 28 days

VVN461, 0.5%

Prednisolone acetate DRUG

Prednisolone acetate, 1%, for up to 28 days

Also known as: Pred Forte

Prednisolone acetate, 1%

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years at the time providing signed informed consent
• At least 1 eye diagnosed with noninfectious anterior uveitis at the time of screening
• Willing and able to comply with study requirements and visit schedule

You may not qualify if:

• Diagnosis of intermediate uveitis, posterior uveitis or panuveitis in either eye at the time of screening

Sponsors & Collaborators

• VivaVision Biotech, Inc: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Uveitis, Anterior

Interventions

prednisolone acetate

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

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

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: November 27, 2023
• Primary Completion: December 29, 2024
• Study Completion: December 29, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

CN (1)