Age-Related Macular Degeneration
Conditions
Keywords
AMD, Age-Related Macular Degeneration, Geographic Atrophy, GA
Brief summary
This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.
Detailed description
Each patient received a sham injection in one eye and active treatment in the other eye. The eye receiving active treatment was selected based on a randomization schedule.
Interventions
0.2 µg/Day in study eye + Sham in fellow eye
Sponsors
Alimera Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis bilateral GA secondary to AMD of ≥ 0.5 and ≤ 7 MPS disc areas * Males and non-pregnant females 55 years old or older
Exclusion criteria
* GA secondary to any condition other than AMD in either eye * History of or current CNV in either eye or the need for anti-angiogenic therapy * Glaucoma or ocular hypertension (IOP \> 21 mmHg OR concurrent therapy at screening with IOP-lowering agents) in either eye * Treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye * Any change in systemic steroid therapy within 3 months of screening * History of vitrectomy in either eye * Any ocular surgery within 12 weeks of screening in either eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Size of Geographic Atrophy | 24 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A, 2, I 0.2 µg/Day + Sham 0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day + Sham treatment in fellow eye | 10 |
| A, 2, II 0.5 µg/Day + Sham 0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day + Sham treatment in fellow eye | 7 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Study Terminated | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | A, 2, II 0.5 µg/Day + Sham | A, 2, I 0.2 µg/Day + Sham | Total |
|---|---|---|---|
| Age, Continuous | 82.55 years STANDARD_DEVIATION 6.056 | 79.95 years STANDARD_DEVIATION 8.976 | 81.02 years STANDARD_DEVIATION 7.799 |
| Age, Customized 35-44 years | 0 participants | 0 participants | 0 participants |
| Age, Customized <35 years | 0 participants | 0 participants | 0 participants |
| Age, Customized 45-54 years | 0 participants | 0 participants | 0 participants |
| Age, Customized 55-64 years | 0 participants | 1 participants | 1 participants |
| Age, Customized 65-74 years | 1 participants | 1 participants | 2 participants |
| Age, Customized 75-84 years | 2 participants | 5 participants | 7 participants |
| Age, Customized ≥85 years | 4 participants | 3 participants | 7 participants |
| Region of Enrollment United States | 7 participants | 10 participants | 17 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 17 | 8 / 10 | 7 / 7 | 5 / 10 | 6 / 7 |
| serious Total, serious adverse events | 3 / 17 | 3 / 10 | 2 / 7 | 3 / 10 | 5 / 7 |
Outcome results
Primary
Change From Baseline in Size of Geographic Atrophy
Time frame: 24 months
Population: Patients received either a 0.2µg/Day or 0.5 µg/Day treatment in the study eye and a sham treatment in the fellow eye.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A, 2, I Sham | Change From Baseline in Size of Geographic Atrophy | 2.513 mm3/year | Standard Deviation 1.5318 |
| A, 2, I 0.2 µg/Day | Change From Baseline in Size of Geographic Atrophy | 2.758 mm3/year | Standard Deviation 1.783 |
| A, 2, II Sham | Change From Baseline in Size of Geographic Atrophy | 2.599 mm3/year | Standard Deviation 2.4005 |
| A, 2, II 0.5 µg/Day | Change From Baseline in Size of Geographic Atrophy | 2.562 mm3/year | Standard Deviation 1.9685 |