A Phase 3 interventional study of Sham Injection and FAI Insert in Posterior Uveitis, Intermediate Uveitis and Panuveitis, sponsored by EyePoint Pharmaceuticals, Inc.. Completed at 15 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-21.
Sponsored by EyePoint Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
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.
61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.
This study's enrollment of 153 is above the median of 37 across 45 interventional studies indexed under Uveitis, Posterior.
Browse Uveitis, Posterior studies →EyePoint Pharmaceuticals, Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:
OR the study eye has experienced recurrence:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sham Injection
Drug: Sham Injection
FAI Insert (0.18 mg fluocinolone acetonide)
Drug: FAI Insert
Placebo
Also known as: Placebo
Fluocinolone Acetonide
Also known as: Fluocinolone Acetonide
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)
Time frame: 6 Months
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)
Time frame: 36 Months
| Milestone | Sham Injection | FAI Insert |
|---|---|---|
| Started | 52 | 101 |
| Completed | 24 | 67 |
| Not completed | 28 | 34 |
Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)
| Participants | Sham Injection | FAI Insert |
|---|---|---|
| Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months | 28 | 22 |
Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population)
| Participants | Sham Injection | FAI Insert |
|---|---|---|
| Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months | 39 | 47 |
Collected over 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham Injection | 0/52 (0%) | 7/52 (13.5%) | 49/52 (94.2%) |
| FAI Insert | 0/101 (0%) | 21/101 (20.8%) | 94/101 (93.1%) |
| Event | Sham Injection | FAI Insert |
|---|---|---|
| Hypotony of eyeEye disorders | 0/52 | 8/101 |
| CataractEye disorders | 0/52 | 2/101 |
| GlaucomaEye disorders | 0/52 | 2/101 |
| UveitisInvestigations | 1/52 | 1/101 |
| SepsisInfections and infestations | 1/52 | 0/101 |
| Septic ShockInfections and infestations | 1/52 | 0/101 |
| Tuberculosis GastrointestinalInfections and infestations | 1/52 | 0/101 |
| Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/52 | 0/101 |
| Rectal CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/52 | 0/101 |
| Acute Kidney InjuryRenal and urinary disorders | 1/52 | 0/101 |
| Event | Sham Injection | FAI Insert |
|---|---|---|
| UveitisEye disorders | 27/52 | 20/101 |
| Cataract subcapsularEye disorders | 9/52 | 36/101 |
| Intraocular pressure increasedInvestigations | 2/52 | 32/101 |
| Macular oedemaEye disorders | 11/52 | 9/101 |
| CataractEye disorders | 10/52 | 17/101 |
| VitritisEye disorders | 10/52 | 9/101 |
| Vitreous hazeEye disorders | 9/52 | 12/101 |
| Cystoid macular oedemaEye disorders | 8/52 | 4/101 |
| Eye painEye disorders | 8/52 | 6/101 |
| Visual acuity reducedEye disorders | 4/52 | 15/101 |
A total of 153 subjects were randomly assigned to 1 of 2 treatment groups: 101 subjects in the FAI insert treatment group and 52 subjects in the sham injection treatment group.
| Age, Continuous(years) | Sham Injection | FAI Insert | Total |
|---|---|---|---|
| Mean | 40.6 ± 13.74 | 39.9 ± 12.87 | 40.1 ± 13.13 |
| Age, Customized(Participants) | Sham Injection | FAI Insert | Total |
|---|---|---|---|
| <20 years | 2 | 0 | 2 |
| 20 to <40 years | 25 | 57 | 82 |
| 40 to <60 years | 21 | 34 | 55 |
| >=60 years | 4 | 10 | 14 |
| Sex: Female, Male(Participants) | Sham Injection | FAI Insert | Total |
|---|---|---|---|
| Female | 34 | 62 | 96 |
| Male | 18 | 39 | 57 |
| Ethnicity (NIH/OMB)(Participants) | Sham Injection | FAI Insert | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 52 | 101 | 153 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sham Injection | FAI Insert | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 49 | 96 | 145 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Intention To Treat (ITT) Population(Participants) | Sham Injection | FAI Insert | Total |
|---|---|---|---|
| Count of participants | 52 | 101 | 153 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2015 to primary completion in Oct 2019, 52 months.
Results were first posted in Jul 2020, 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluocinolone Acetonide
EyePoint Pharmaceuticals, Inc.