Posterior UveitisPhase 3NCT02746991
Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis
A Phase 3 study testing FAI Insert in people with Posterior Uveitis and Intermediate Uveitis, run by EyePoint Pharmaceuticals, Inc. at 15 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Uveitis, Intermediate Uveitis, Panuveitis
- 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
- 153 participants
- Where
- 15 sitesIndia
- Study dates
- 2 Jun 2015to 4 Oct 2019
- 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
- At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.
- Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (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
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- Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- 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 administrations 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
Who cannot join
- Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (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)
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- 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 structures
- 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 Intraocular pressure (IOP) in the normal range (10-21 mmHg)
- 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 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
India15 sites
C.H. Nagri Municipal Eye Hospital
Ahmedabad, Gujarat, 380006
Sankara Nethralaya hospital
Chennai, Tamil Nadu, 600006
Vasan Eye Care Hospital
Chennai, Tamil Nadu, 600015
Sri Ramachandra Hospital
Chennai, Tamil Nadu, 600116
Dr. Shroff's Charity Eye Hospital
Daryāganj, New Delhi, 110002
Sri Sankaradeva Nethralaya, Guwahati
Guwahati, Assam, 781028
LV. Prasad Eye Institute
Hyderabad, Andhra Pradesh, 500034
J L Rohatgi Memorial Eye Hospital
Kanpur, Uttar Pradesh, 208005
Regional Institute of Ophthalmology
Kolkata, West Bengal, 700073
King George's Medical University
Lucknow, Uttar Pradesh, 226003
Seth G.S. Medical College & K.E.M Hospital
Mumbai, Maharashtra, 400012
ICARE Eye Hospital and Research centre
Noida, Uttar Pradesh, 201301
Regional Institute of Opthalmology
Patna, Bihar, 800014
Deenanath Mangeshkar Hospital, Pune
Pune, Maharashtra, 411004
PBMA'S, H. V. Desai Eye Hospital
Pune, Maharashtra, 411060
About this study
Official title: A Multi-center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye
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.
Read the detailed description
This is a 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.
- Conditions
- Posterior Uveitis, Intermediate Uveitis, Panuveitis
- Being tested
- Sham Injection, FAI Insert
- Medical subject headings
- Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham InjectionDrug
Also called Placebo
Placebo
FAI InsertDrug
Also called Fluocinolone Acetonide
Fluocinolone Acetonide
| 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.
Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months
Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)
Measured: 6 Months
Secondary outcomes (1)
Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months
Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population)
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 posted21 Apr 2016 (estimated)
- Study start2 Jun 2015
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
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 Posterior 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Flavio Leonin Jr., MD, Study director, EyePoint Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746991
- Sponsor's protocol ID
- PSV-FAI-005
- Status last verified
- Jul 2020
- First submitted
- 19 Apr 2016
- Last updated
- 21 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Biswas J, Tyagi M, Agarwal M; PSV-FAI-005 Investigation Group. The 0.2-mug/day Fluocinolone Acetonide Intravitreal Implant in Chronic Noninfectious Posterior Uveitis: A 3-year Randomized Trial in India. Ophthalmol Sci. 2023 Sep 16;4(1):100403. doi: 10.1016/j.xops.2023.100403. eCollection 2024 Jan-Feb.
PubMed 38027419
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye
- ClinicalTrials.gov ID
- NCT02746991
- Acronym / sponsor ID
- PSV-FAI-005
- Conditions
- Posterior Uveitis, Intermediate Uveitis, Panuveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 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.
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
- At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.
- Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
- Subject is not planning to undergo elective ocular surgery during the study
Key exclusion criteria (30 listed)
- Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (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 |
|---|---|---|
| Sham InjectionAlso: PlaceboPlacebo | Drug | Sham Injection |
| FAI InsertAlso: Fluocinolone AcetonideFluocinolone Acetonide | Drug | FAI Insert |
Primary outcome
Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months
Time frame: 6 Months
Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)
1 secondary outcome
Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months
Time frame: 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38027419Biswas J, Tyagi M, Agarwal M; PSV-FAI-005 Investigation Group. The 0.2-mug/day Fluocinolone Acetonide Intravitreal Implant in Chronic Noninfectious Posterior Uveitis: A 3-year Randomized Trial in India. Ophthalmol Sci. 2023 Sep 16;4(1):100403. doi: 10.1016/j.xops.2023.100403. eCollection 2024 Jan-Feb.
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A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
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Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant
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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.
Flavio Leonin Jr., MD study director
EyePoint Pharmaceuticals, Inc.
15 sites in 1 country: 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 Posterior Uveitis and Intermediate Uveitis, run by EyePoint Pharmaceuticals, Inc. at 15 sites in India.
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 30 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in India. 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 7 Jul 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?
Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months (time frame: 6 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 NCT02746991, 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 21 Jul 2020.