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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02125266
Other study ID # V4041
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received April 24, 2014
Last updated December 7, 2016
Start date April 2014
Est. completion date March 2015

Study information

Verified date December 2016
Source Forsight Vision4
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date March 2015
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
V404
Sustained Release

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Forsight Vision4

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in macular thickness by ocular coherence tomography Baseline, 6 Months No
Primary Frequency of adverse events 6 months Yes
Secondary Change in vitreous haze score Baseline, 6 Months No
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