Non-Infectious UveitisPhase 3MkIINCT02748512
Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis
A Phase 3 study testing FAI Insert administered using the Mk II inserter and FAI Insert administered using the Mk I inserter in people with Non-Infectious Uveitis, run by EyePoint Pharmaceuticals, Inc. at 6 sites in United States.
Trial summary
This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the Mk II inserter and the safety of the FAI insert, in 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 administered using the Mk II inserter and FAI Insert administered using the Mk I inserter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Feb 2016to 17 Aug 2017
- 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
- At least one eye has a history of non-infectious uveitis affecting the posterior segment
- Subject has ability to understand and sign the Informed Consent Form
- Subject is willing and able to comply with study requirements
Who cannot join
- Allergy to fluocinolone acetonide or any component of the FAI insert
- Ocular malignancy in either eye, including choroidal melanoma
- Uveitis with infectious etiology
- Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
- Current mycobacterial infections of the eye or fungal diseases of ocular structures
- Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV) or syphilis
Show all 18Show fewer
- Systemic infection within 30 days prior to study Day 1
- Peripheral retinal detachment in area of insertion
- Elevated intraocular pressure (IOP) > 21 mmHg, or chronic hypotony < 6 mmHg
- Concurrent therapy at screening with IOP-lowering pharmacologic agent in the study eye
- Current 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)
- Known history of clinically significant IOP elevation in response to steroid treatment in either eye, 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)
- Ocular surgery or capsulotomy performed on the study eye within 30 days prior to study Day 1
- Intravitreal treatment of study eye: with FAI insert within 36 months prior to study Day 1;with Retisert within 30 months prior to study Day 1; with Ozurdex within 90 days prior to study Day 1; or with Triesence or Trivaris within 30 days prior to study Day 1
- Peri-ocular or subtenon steroid treatment of study eye within 30 days prior to study Day 1
- Treatment with an investigational drug or device within 30 days prior to study Day 1, except the FAI insert within this protocol
- 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
- Any condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texas Retina Associates
Arlington, Texas, 76012
Cleveland Clinic Foundation Cole Eye Institute
Cleveland, Ohio, 44195
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, 80909
Duke Eye Center
Durham, North Carolina, 27710
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
Massachusetts Eye Research and Surgery Institution / Ocular Immunology & Uveitis Foundation
Waltham, Massachusetts, 02451
About this study
Official title: A Controlled, Multi-Center Study of the Utilization and Safety of the MkII Inserter and the Safety of the FAI Insert in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye.
This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the Mk II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.
Read the detailed description
This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the MK II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.
- Conditions
- Non-Infectious Uveitis
- Being tested
- FAI Insert administered using the Mk II inserter, FAI Insert administered using the Mk I inserter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAI Insert administered using the Mk II inserterDrug
Also called Fluocinolone Acetonide Intravitreal (FAI)
FAI Insert administered using the Mk I inserterDrug
Also called Fluocinolone Acetonide Intravitreal (FAI)
| Study group | Role | What they receive |
|---|---|---|
| FAI Insert administered using the Mk II inserter | Experimental | The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. Receives: Drug: FAI Insert administered using the Mk II inserter |
| FAI Insert administered using the Mk I inserter | Active comparator | The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. Receives: Drug: FAI Insert administered using the Mk I inserter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment.
The primary utilization endpoint was defined as the proportion of intravitreal insertion procedures that were assessed by the investigator as satisfactory. A satisfactory procedure was defined as one receiving a score from the Investigator as either Very Easy, Easy, or Routine.
Measured: Day 7
Secondary outcomes (1)
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages.
To assess the safety of the FAI insert during 12 months following treatment reported as percentages.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start23 Feb 2016
- Primary completion17 Aug 2017
- Study completion17 Aug 2017
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Flavio Leonin Jr., MD, Principal investigator, pSivida Corp, Senior Manager, Clinical AffairsGerard E Riedel, PhD, Study chair, pSivida Corp, Vice President, Regulatory AffairsPaul Ashton, PhD, Study director, pSivida Corp, Chief Executive Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748512
- Sponsor's protocol ID
- PSV-FAI-006
- Acronym
- MkII
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2016
- Last updated
- 1 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Multi-Center Study of the Utilization and Safety of the MkII Inserter and the Safety of the FAI Insert in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye.
- ClinicalTrials.gov ID
- NCT02748512
- Acronym / sponsor ID
- MkII / PSV-FAI-006
- Conditions
- Non-Infectious Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Posted 1 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the Mk II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.
Detailed description
This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the MK II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAI Insert administered using the Mk II inserter | Experimental | Drug: FAI Insert administered using the Mk II inserterThe test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. |
| FAI Insert administered using the Mk I inserter | Active comparator | Drug: FAI Insert administered using the Mk I inserterThe test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant female at least 18 years of age at time of consent
- At least one eye has a history of non-infectious uveitis affecting the posterior segment
- Subject has ability to understand and sign the Informed Consent Form
- Subject is willing and able to comply with study requirements
Key exclusion criteria (18 listed)
- Allergy to fluocinolone acetonide or any component of the FAI insert
- Ocular malignancy in either eye, including choroidal melanoma
- Uveitis with infectious etiology
- Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
- Current mycobacterial infections of the eye or fungal diseases of ocular structures
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 Insert administered using the Mk II inserterAlso: Fluocinolone Acetonide Intravitreal (FAI) | Drug | FAI Insert administered using the Mk II inserter |
| FAI Insert administered using the Mk I inserterAlso: Fluocinolone Acetonide Intravitreal (FAI) | Drug | FAI Insert administered using the Mk I inserter |
Primary outcome
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment.
Time frame: Day 7
The primary utilization endpoint was defined as the proportion of intravitreal insertion procedures that were assessed by the investigator as satisfactory. A satisfactory procedure was defined as one receiving a score from the Investigator as either Very Easy, Easy, or Routine.
1 secondary outcome
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages.
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 principal investigator
pSivida Corp, Senior Manager, Clinical Affairs
Gerard E Riedel, PhD study chair
pSivida Corp, Vice President, Regulatory Affairs
Paul Ashton, PhD study director
pSivida Corp, Chief Executive Officer
6 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 administered using the Mk II inserter and FAI Insert administered using the Mk I inserter in people with Non-Infectious Uveitis, run by EyePoint Pharmaceuticals, Inc. at 6 sites in United States.
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 4 inclusion and 18 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. 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 1 May 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?
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2020.