Trial Outcomes & Findings for Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK) (NCT NCT01448213)

NCT ID: NCT01448213

Last Updated: 2014-09-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 264 participants
• Primary outcome timeframe: Within 1 year
• Results posted on: 2014-09-03

Participant Flow

Participant milestones

Measure	Fluorometholone 0.1% Solution Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study. Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.	Prednisolone Acetate 1% Solution Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study. Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Overall Study STARTED	130	134
Overall Study COMPLETED	113	112
Overall Study NOT COMPLETED	17	22

Reasons for withdrawal

Measure	Fluorometholone 0.1% Solution Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study. Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.	Prednisolone Acetate 1% Solution Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study. Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Overall Study Lost to Follow-up	12	10
Overall Study Adverse Event	4	10
Overall Study Protocol Violation	1	2

Baseline Characteristics

Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)

Baseline characteristics by cohort

Measure	Fluorometholone 0.1% Solution n=161 Participants Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study. Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.	Prednisolone Acetate 1% Solution n=164 Participants Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study. Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.	Total n=325 Participants Total of all reporting groups
Age, Continuous	69 years n=93 Participants	67 years n=4 Participants	68 years n=27 Participants
Sex: Female, Male Female	107 Participants n=93 Participants	105 Participants n=4 Participants	212 Participants n=27 Participants
Sex: Female, Male Male	54 Participants n=93 Participants	59 Participants n=4 Participants	113 Participants n=27 Participants

PRIMARY outcome

Timeframe: Within 1 year

Outcome measures

Measure	Fluorometholone 0.1% Solution n=161 Number of Eyes Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study. Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.	Prednisolone Acetate 1% Solution n=164 Number of Eyes Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study. Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Number of Eyes With Immunologic Graft Rejection Episodes	2 eyes	0 eyes

SECONDARY outcome

Timeframe: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK

Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.

Outcome measures

Measure	Fluorometholone 0.1% Solution n=161 eyes Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study. Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.	Prednisolone Acetate 1% Solution n=164 eyes Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study. Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Number of Eyes With Intraocular Pressure (IOP) Elevation	9 eyes	32 eyes

Adverse Events

Fluorometholone 0.1% Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prednisolone Acetate 1% Solution

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fluorometholone 0.1% Solution n=130 participants at risk Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study. Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.	Prednisolone Acetate 1% Solution n=134 participants at risk Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study. Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Eye disorders Intraocular pressure control problem requiring discontinuation of study drug	0.00% 0/130	9.7% 13/134 • Number of events 13

Additional Information

Marianne O. Price, PhD

Cornea Research Foundation of America

Phone: 317-814-2990

Email: mprice@cornea.org

Results disclosure agreements

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