Trial Outcomes & Findings for Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis (NCT NCT02748512)

Last Updated: 2020-05-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

26 participants

Primary outcome timeframe

Day 7

Results posted on

2020-05-01

Participant Flow

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

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.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Mk II Inserter Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter	Mk I Inserter Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter
Overall Study STARTED	14 27	12 11
Overall Study COMPLETED	13 26	11 10
Overall Study NOT COMPLETED	1 1	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Mk II Inserter Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter	Mk I Inserter Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FAI Insert Administered Using the Mk II Inserter n=27 Eyes 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	FAI Insert Administered Using the Mk I Inserter n=11 Eyes 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	Total n=38 Eyes Total of all reporting groups
Age, Continuous	51.3 Years STANDARD_DEVIATION 11.82 • n=14 Eyes	48.9 Years STANDARD_DEVIATION 11.19 • n=23 Eyes	50.4 Years STANDARD_DEVIATION 12.12 • n=50 Eyes
Sex: Female, Male Female	18 Eyes n=14 Eyes	7 Eyes n=23 Eyes	25 Eyes n=50 Eyes
Sex: Female, Male Male	9 Eyes n=14 Eyes	4 Eyes n=23 Eyes	13 Eyes n=50 Eyes
Race/Ethnicity, Customized White	21 Eyes n=14 Eyes	8 Eyes n=23 Eyes	29 Eyes n=50 Eyes
Race/Ethnicity, Customized Black or African American	5 Eyes n=14 Eyes	3 Eyes n=23 Eyes	8 Eyes n=50 Eyes
Race/Ethnicity, Customized Asian	1 Eyes n=14 Eyes	0 Eyes n=23 Eyes	1 Eyes n=50 Eyes
Region of Enrollment United States	27 Eyes n=14 Eyes	11 Eyes n=23 Eyes	38 Eyes n=50 Eyes
Overall Eyes Evaluated	27 Eyes n=14 Eyes	11 Eyes n=23 Eyes	38 Eyes n=50 Eyes

PRIMARY outcome

Timeframe: Day 7

Population: Intent-to-treat population - Assessment Categories

Outcome measures

Outcome measures
Measure	Mk II Inserter n=27 Eyes Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter	Mk I Inserter n=11 Eyes Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. Very Easy	10 Eyes	3 Eyes
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. Easy	3 Eyes	2 Eyes
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. Routine	5 Eyes	0 Eyes
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. Difficult	7 Eyes	4 Eyes
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. Very Difficult	2 Eyes	2 Eyes

SECONDARY outcome

Timeframe: Month 12

Population: Overall Summary of Treatment-Emergent Ocular Adverse Events at Month 12 (Safety Population). Note 27/11 (ITT Population) and 26/12 (Safety Population).

To assess the safety of the FAI insert during 12 months following treatment reported as percentages.

Outcome measures

Outcome measures
Measure	Mk II Inserter n=26 Eyes Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter	Mk I Inserter n=12 Eyes Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. TEAE	12 Eyes	7 Eyes
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. Serious TEAE	1 Eyes	1 Eyes
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. Treatment-related TEAE	10 Eyes	4 Eyes
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. Treatment-related serious TEAE	0 Eyes	0 Eyes
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. TEAE leading to FAI insert removal	0 Eyes	1 Eyes
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. TEAE leading to study discontinuation	0 Eyes	0 Eyes
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. AE leading to death	0 Eyes	0 Eyes

Adverse Events

Mk II Inserter

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Mk I Inserter

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mk II Inserter n=14 participants at risk Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter	Mk I Inserter n=12 participants at risk Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter
Cardiac disorders Tachycardia	7.1% 1/14 • 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)	8.3% 1/12 • 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)
Gastrointestinal disorders Pancreatitis	7.1% 1/14 • 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)	8.3% 1/12 • 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)
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	7.1% 1/14 • 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)	8.3% 1/12 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Neoplasm	7.1% 1/14 • 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)	0.00% 0/12 • 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)
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • 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)	8.3% 1/12 • 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)
Eye disorders Retinal Detachment	0.00% 0/14 • 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)	8.3% 1/12 • 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)
Psychiatric disorders Factitious Disorder	7.1% 1/14 • 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)	0.00% 0/12 • 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)

Other adverse events

Additional Information

Kelley Collins-Winters, RTR, BS, MBA

Axiom

Phone: 469-667-6655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI is restricted from publicly releasing results.
Publication restrictions are in place

Restriction type: OTHER