Phase 3
N=129
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
Non-Infectious Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT01694186 ↗Enrolled (actual)
129
Serious AEs
35.7%
Results posted
Mar 2020
Primary outcome: Primary: Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit — 12; 5; 39; 77 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FAI insert (Drug); Sham injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EyePoint Pharmaceuticals, Inc.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit |
12; 5; 39; 77; 12; 16 | — |
Summary
A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant female at least 18 years of age at time of consent
- One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis > 1 year duration.
- During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:
- systemic corticosteroid or other systemic therapies given for at least 3 months, and/or
- at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis
OR the study eye has experienced recurrence:
- at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid
- At the time of enrollment (Day 1), study eye has 21 mmHg or concurrent therapy at screening with any IOP-lowering pharmacologic agent in the study eye
- Chronic hypotony ( 15mg prednisone daily) or chronic systemic immunosuppressive therapy
- Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1
- Subjects who test positive for human immune deficiency virus (HIV) or syphilis during screening
- Mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis
- Systemic infection within 30 days prior to study Day 1
- Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study
- Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study
- Treatment with an investigational drug or device within 30 days prior to study Day 1
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit
- Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years
Data sourced from ClinicalTrials.gov (NCT01694186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.