Macular Edema, Retinal Vein Occlusion
Conditions
Keywords
Macular edema secondary to RVO
Brief summary
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
Interventions
0.2 µg/day
Sponsors
Alimera Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) * Central subfield thickness \> 300 μm * BCVA of ≥ 24 and ≤ 68 letters * Males and non-pregnant females 18 years and over
Exclusion criteria
* Macular edema secondary to any condition other than RVO * Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye * Cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss * Glaucoma or ocular hypertension (IOP \> 21 mmHg or concurrent therapy at screening with IOP-lowering agents) * Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye * Any change in systemic steroid therapy within 3 months of screening * History of vitrectomy in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 3 months | To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluocinolone Acetonide 0.2 µg/Day 0.2 µg/day
Fluocinolone Acetonide: 0.2 µg/day | 14 |
| Fluocinolone Acetonide 0.5 µg/Day 0.5 µg/day
Fluocinolone Acetonide: 0.5 µg/day | 6 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Study Terminated | 8 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Fluocinolone Acetonide 0.5 µg/Day | Fluocinolone Acetonide 0.2 µg/Day | Total |
|---|---|---|---|
| Age, Continuous | 73.52 years STANDARD_DEVIATION 13.091 | 67.50 years STANDARD_DEVIATION 9.287 | 69.30 years STANDARD_DEVIATION 10.589 |
| Age, Customized 35-45 years | 0 participants | 0 participants | 0 participants |
| Age, Customized <35 years | 0 participants | 0 participants | 0 participants |
| Age, Customized 45-55 years | 0 participants | 2 participants | 2 participants |
| Age, Customized 55-65 years | 2 participants | 3 participants | 5 participants |
| Age, Customized 65-75 years | 0 participants | 6 participants | 6 participants |
| Age, Customized 75-85 years | 3 participants | 2 participants | 5 participants |
| Age, Customized ≥85 years | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 6 participants | 14 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 14 | 6 / 6 |
| serious Total, serious adverse events | 8 / 14 | 4 / 6 |
Outcome results
Primary
Visual Acuity
To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluocinolone Acetonide 0.2 µg/Day | Visual Acuity | Baseline | 47.0 Letters | Standard Error 4.5 |
| Fluocinolone Acetonide 0.2 µg/Day | Visual Acuity | Month 3 - Change from Baseline | 7.0 Letters | Standard Error 2.51 |
| Fluocinolone Acetonide 0.5 µg/Day | Visual Acuity | Baseline | 53.5 Letters | Standard Error 4.13 |
| Fluocinolone Acetonide 0.5 µg/Day | Visual Acuity | Month 3 - Change from Baseline | 9.2 Letters | Standard Error 2.37 |