Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

ForSight VISION4

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Uveitis, Intermediate; Uveitis, Posterior

Treatments: Drug: V404

Study type: Interventional

Funder types: Industry

Identifiers

NCT02125266

V4041

Details and patient eligibility

About

This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Confirmed diagnosis of active uveitis
• Sufficient lens/media clarity
• Meet best-corrected visual acuity criteria
• Willing and able to use contraception

Exclusion criteria

• Pregnant, breast feeding
• Uncontrolled glaucoma
• Intraocular surgery or periocular/intraocular injections within 6 weeks
• Periocular or intraocular steroid within 3 months
• Prior vitrectomy
• Prior corneal transplant
• Prior fluocinolone implant
• Allergy or sensitivity to study drug
• Participation in other trial within 30 days
• Abnormal liver function
• History of positive serum tuberculosis test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 2 patient groups

Low Dose V404 PDS

Experimental group

Description:

Sustained intravitreal delivery of methotrexate (0.6 mg)

Treatment:

Drug: V404

High Dose V404 PDS

Experimental group

Description:

Sustained intravitreal delivery of methotrexate (2.3 mg)

Treatment:

Drug: V404