Trial Outcomes & Findings for The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot (NCT NCT00605423)
NCT ID: NCT00605423
Last Updated: 2014-04-07
Results Overview
Visual acuity is measured using ETDRS charts at 4 meters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
6 mos
Results posted on
2014-04-07
Participant Flow
Participant milestones
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
Dose 0.2 ug/day Medidur implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
Dose 0.5 ug/day Medidur implant
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot
Baseline characteristics by cohort
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=4 Participants
Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=2 Participants
Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Age, Continuous
|
75.4 years
STANDARD_DEVIATION 5.3 • n=93 Participants
|
75.9 years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
75.5 years
STANDARD_DEVIATION 4.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
2 participants
n=4 Participants
|
6 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 mosVisual acuity is measured using ETDRS charts at 4 meters.
Outcome measures
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=4 Participants
Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=2 Participants
Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
|
|---|---|---|
|
Mean Change From Baseline in Visual Acuity
|
1.8 ETDRS letters
Standard Deviation 5.19
|
1.0 ETDRS letters
Standard Deviation 8.49
|
SECONDARY outcome
Timeframe: 6 mosOutcome measures
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=4 Participants
Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=2 Participants
Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
|
|---|---|---|
|
Number of Patients Developing Cataracts
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 6 mosIOP stands for intra ocular pressure
Outcome measures
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=4 Participants
Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=2 Participants
Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
|
|---|---|---|
|
Change in IOP From Baseline
|
1.30 mmHg
Standard Deviation 5.81
|
2.65 mmHg
Standard Deviation 1.91
|
Adverse Events
Fluocinolone Acetonide: 0.2 ug/Day Implant
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Fluocinolone Acetonide: 0.5 ug/Day Implant
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=4 participants at risk
Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=2 participants at risk
Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
|
|---|---|---|
|
Surgical and medical procedures
Cataract Operation
|
100.0%
4/4 • Number of events 4
|
50.0%
1/2 • Number of events 1
|
|
Surgical and medical procedures
Cataract Operation Complication
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
Other adverse events
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=4 participants at risk
Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=2 participants at risk
Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
|
|---|---|---|
|
Eye disorders
Cataract
|
75.0%
3/4 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
|
Eye disorders
Cataract Subcapsular
|
25.0%
1/4 • Number of events 3
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
Contrast Media Reaction
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Intraocular Pressure Increased
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Surgical and medical procedures
Cataract Operation Complication
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60