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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAI Insert administered using the Mk II inserter | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavio Leonin Jr., MD | pSivida Corp, Senior Manager, Clinical Affairs | Principal Investigator |
| Gerard E Riedel, PhD | pSivida Corp, Vice President, Regulatory Affairs | Study Chair |
| Paul Ashton, PhD | pSivida Corp, Chief Executive Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Southern Colorado, PC | Colorado Springs | Colorado | 80909 | United States | ||
| Massachusetts Eye Research and Surgery Institution / Ocular Immunology & Uveitis Foundation |
Prior to analysis no Subjects were Excluded From the Utilization Analysis (i.e., completed Day 7). 1 MKI and 1 MKII eyes were lost to follow-up at Month 12.
One subject was assigned to the Mk II; however, received treatment with the Mk I after attempted to use 2 different Mk II inserters without success and switched to the Mk I inserter. The data for this subject were included in the Mk II inserter treatment group for ITT population and in the Mk I inserter treatment group for the safety population
| ID | Title | Description |
|---|---|---|
| FG000 | Mk II Inserter | Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter |
| FG001 | Mk I Inserter | Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2016 | Jan 29, 2020 |
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| FAI Insert administered using the Mk I inserter | Drug |
|
|
| Waltham |
| Massachusetts |
| 02451 |
| United States |
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Foundation Cole Eye Institute | Cleveland | Ohio | 44195 | United States |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| COMPLETED | 14 subjects had 1 study eye treated and 12 subjects had 2 study eyes treated |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FAI Insert Administered Using the Mk II Inserter | 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. FAI Insert administered using the Mk II inserter |
| BG001 | FAI Insert Administered Using the Mk I Inserter | 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. FAI Insert administered using the Mk I inserter |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years | Eyes |
| ||||||||||||||
| Sex: Female, Male | Count of Units | Eyes | Eyes |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Units | Eyes | Eyes |
| |||||||||||||||
| Region of Enrollment | Number | Eyes | Eyes |
| |||||||||||||||
| Overall Eyes Evaluated | Count of Units | Eyes | Eyes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat population - Assessment Categories | Posted | Count of Units | Eyes | Day 7 | Eyes | Eyes |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Overall Summary of Treatment-Emergent Ocular Adverse Events at Month 12 (Safety Population). Note 27/11 (ITT Population) and 26/12 (Safety Population). | Posted | Count of Units | Eyes | Month 12 | Eyes | Eyes |
|
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Overall Summary of Treatment-Emergent Non-ocular and Ocular Adverse Events at Month 12 (Safety Population - MKII 26 eyes; MKI 12 eyes)
Overall Summary of Treatment-Emergent Non-ocular and Ocular Adverse Events at Month 12 (Safety Population - MKII 26 eyes; MKI 12 eyes)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mk II Inserter | Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter | 0 | 14 | 4 | 14 | 14 | 14 |
| EG001 | Mk I Inserter | Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter | 0 | 12 | 3 | 12 | 11 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Renal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Retinal Detachment | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Factitious Disorder | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Candida Infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Cellulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Oral Herpes | Infections and infestations | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Tooth Infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Pancreatic cyst | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Toothache | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Gout | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Pituitary-dependent Cushing's syndrome | Endocrine disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Laboratory test abnormal | Investigations | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Hypertension | Vascular disorders | MedDRA (19.1) | Systematic Assessment | By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated. |
|
| Anterior chamber cell | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Computer vision syndrome | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Meibomianitis | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Posterior capsule opacification | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Retinal pigment epitheliopathy | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Retinal vascular disorder | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Subretinal fluid | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vitreous haze | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intraocular pressure decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (19.1) | Systematic Assessment |
| |
| Device failure | Product Issues | MedDRA (19.1) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Factitious disorder | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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The PI is restricted from publicly releasing results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelley Collins-Winters, RTR, BS, MBA | Axiom | 469-667-6655 | kelleyc@axiom.cc |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2016 | Jan 29, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Male |
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| Black or African American |
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| Asian |
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| Routine |
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| Difficult |
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| Very Difficult |
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| Eyes |
|
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