Phase 3
N=153
Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis
Posterior Uveitis · Intermediate Uveitis · Panuveitis
Bottom Line
View on ClinicalTrials.gov: NCT02746991 ↗Enrolled (actual)
153
Serious AEs
18.3%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months — 28; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sham Injection (Drug); FAI Insert (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EyePoint Pharmaceuticals, Inc.
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months |
28; 22 | — |
| SECONDARY Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months |
39; 47 | — |
Summary
Phase 3, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.
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
- 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 have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis
- 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 (NCT02746991). 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.