Trial Outcomes & Findings for Sirolimus as Therapeutic Approach to Uveitis (NCT NCT00908466)

NCT ID: NCT00908466

Last Updated: 2018-08-20

Results Overview

Vitreous Haze is calculated using a 9 step photographic haze in uveitis patients using fundus photograph

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-08-20

Participant Flow

Participant milestones

Measure	Intravitreal Injection Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120.	Subconjunctival Injection Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.
Overall Study STARTED	15	15
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sirolimus as Therapeutic Approach to Uveitis

Baseline characteristics by cohort

Measure	Intravitreal Injection n=15 Participants Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120.	Subconjunctival Injection n=15 Participants Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.	Total n=30 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 19.8 • n=5 Participants	48 years STANDARD_DEVIATION 18.2 • n=7 Participants	47 years STANDARD_DEVIATION 18.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized White	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Vitreous Haze is calculated using a 9 step photographic haze in uveitis patients using fundus photograph

Outcome measures

Measure	Intravitreal Injection n=15 Participants Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120.	Subconjunctival Injection n=15 Participants Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.
Number of Participants With at Least 2-step Decrease in Vitreous Haze (VH)	4 participants	4 participants

SECONDARY outcome

Timeframe: 6 and 12 months

Outcome measures

Outcome data not reported

Adverse Events

Intravitreal Injection

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Subconjunctival Injection

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intravitreal Injection n=15 participants at risk Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120.	Subconjunctival Injection n=15 participants at risk Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.
Eye disorders Serious Ocular Adverse Event	6.7% 1/15 • Number of events 1 • 6 Months	0.00% 0/15 • 6 Months

Other adverse events

Measure	Intravitreal Injection n=15 participants at risk Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120.	Subconjunctival Injection n=15 participants at risk Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.
Eye disorders Inflammation at the injection site	0.00% 0/15 • 6 Months	40.0% 6/15 • Number of events 7 • 6 Months

Additional Information

Quan Dong Nguyen, MD, MSc

University of Nebraska

Phone: 4025591855

Email: quan.nguyen@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place