Non-Infectious UveitisPhase 3FAINCT01694186
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
A Phase 3 study testing FAI insert in people with Non-Infectious Uveitis, run by EyePoint Pharmaceuticals, Inc. at 34 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Infectious Uveitis
- What is being tested?
- FAI insert
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 34 sitesin 6 countries
- Study dates
- 2 Aug 2013to 26 Mar 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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 < 10 anterior chamber cells/HPF and a vitreous haze ≤ grade 2.
- Visual acuity of study eye is at least 15 letters on the ETDRS chart
- Subject is not planning to undergo elective ocular surgery during the study
- Subject has ability to understand and sign the Informed Consent Form
- Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Allergy to fluocinolone acetonide or any component of the FAI insert
- History of posterior uveitis only that is not accompanied by vitritis or macular edema
- History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
- Uveitis with infectious etiology
- Vitreous hemorrhage
- Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)
Show all 31Show fewer
- Ocular malignancy in either eye, including choroidal melanoma
- Toxoplasmosis scar in study eye; or scar related to previous viral retinitis
- Previous viral retinitis
- Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structure
- Media opacity precluding evaluation of retina and vitreous
- Peripheral retinal detachment in area of insertion
- Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg)
- Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at screening with any IOP-lowering pharmacologic agent in the study eye
- Chronic hypotony (< 6 mmHg)
- Ocular surgery on the study eye within 3 months prior to study Day 1
- Capsulotomy in study eye within 30 days prior to study Day 1
- Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1
- Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1
- Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1
- Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1
- Subjects requiring chronic systemic or inhaled corticosteroid therapy (>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
Trial locations and contacts
34 sites in 6 countries.
34 sites in 6 countries
United States16 sites
Texas Retina Associates
Arlington, Texas, 76012
Retina Vitreaous Associates
Beverly Hills, California, 90211
Ocular Immunology and Uveitis Foundation
Cambridge, Massachusetts, 02142
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909
Duke University Eye Center
Durham, North Carolina, 27710
Retina Consultants of Houston
Houston, Texas, 77030
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
Ophthalmology & Visual Sciences
Lexington, Kentucky, 40508
University of Nebraska Medical Center
Omaha, Nebraska, 68198
OHSU Casey Eye Institute
Portland, Oregon, 97239
Retinal Consultants Medical Group, Inc
Sacramento, California, 95819
Foresight Studies, LLC
San Antonio, Texas, 78240
Retina Consultants
Slingerlands, New York, 12159
Retina Macula Institute
Torrance, California, 90503
India6 sites
C.H Nagri Municipal Eye Hospital
Ahmedabad, Gujarat
PBMA'S H.V. Desai Eye Hospital
Hadapsar, Pune
L. V. Prasad Eye Institute - Hospital
Hyderabad, Andhra Pradesh
King George's Medical University
Lucknow, Uttar Pradesh
Seth G.S. Medical College & KEM Hospital
Parel, Mumbai
L.V. Prasad Eye Institute
Pātia, Bhubaneshwar
United Kingdom6 sites
Royal Hospitals Trust
Belfast
Birmingham and Midland Eye Centre
Birmingham
Bradford Royal Infirmary
Bradford
Gloucestershire Royal Hospital
Gloucester
Moorfields Eye Hospital
London
St Thomas Hospital
London
Israel3 sites
Hadassah University Hospital Ein Kerem
Jerusalem
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Qiryat Ono
Germany2 sites
Augenarzte am St. Franziskus Hospital
Münster
Universitatsklinikum Tubingen
Tübingen
About this study
Official title: A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
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.
Read the detailed description
This is a phase 3, multi-national, 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 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.
- Conditions
- Non-Infectious Uveitis
- Being tested
- FAI insert, Sham injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAI insertDrug
Also called Active Drug
Sham injectionDrug
Also called Sham Comparator
| Study group | Role | What they receive |
|---|---|---|
| sham injection | Sham comparator | sham injection Receives: Drug: Sham injection |
| FAI insert | Experimental | FAI insert (0.18 mg fluocinolone acetonide) Receives: Drug: FAI insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study start2 Aug 2013
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Infectious UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Jaffe, MD, Principal investigator, Duke University Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694186
- Sponsor's protocol ID
- PSV-FAI-001
- Acronym
- FAI
- Status last verified
- Mar 2021
- First submitted
- 24 Sep 2012
- Last updated
- 2 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jaffe GJ, Pavesio CE; Study Investigators. Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis: Three-Year Results. Ophthalmology. 2020 Oct;127(10):1395-1404. doi: 10.1016/j.ophtha.2020.04.001. Epub 2020 Apr 17.
PubMed 32624244
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
- ClinicalTrials.gov ID
- NCT01694186
- Acronym / sponsor ID
- FAI / PSV-FAI-001
- Conditions
- Non-Infectious Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2013 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 3, multi-national, 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham injection | Sham comparator | Drug: Sham injectionsham injection |
| FAI insert | Experimental | Drug: FAI insertFAI insert (0.18 mg fluocinolone acetonide) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (31 listed)
- Allergy to fluocinolone acetonide or any component of the FAI insert
- History of posterior uveitis only that is not accompanied by vitritis or macular edema
- History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
- Uveitis with infectious etiology
- Vitreous hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAI insertAlso: Active Drug | Drug | FAI insert |
| Sham injectionAlso: Sham Comparator | Drug | sham injection |
Primary outcome
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
Time frame: 36 months
Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32624244Jaffe GJ, Pavesio CE; Study Investigators. Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis: Three-Year Results. Ophthalmology. 2020 Oct;127(10):1395-1404. doi: 10.1016/j.ophtha.2020.04.001. Epub 2020 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Jaffe, MD principal investigator
Duke University Eye Center
34 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FAI insert in people with Non-Infectious Uveitis, run by EyePoint Pharmaceuticals, Inc. at 34 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, India, United Kingdom, Israel, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01694186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.