Age Related Macular Degeneration
Conditions
Keywords
AMD, Almera, Steroid, Macular, ARMD
Brief summary
Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be required to maintain this effect. It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections.
Detailed description
Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be required to maintain this effect. The use of the glucocorticoids such as triamcinolone acetonide as adjunct treatment for exudative age-related macular degeneration has been reported to enhance the efficacy of photodynamic therapy with Visudyne® (verteporphin for injection). It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections. This study is a pilot phase 2b study to test this hypothesis. The safety assessments will continue through 36 months.This study will compare the safety 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau.
Interventions
DRUGFluocinolone Acetonide/Medidur
0.2 ug/day implant
Sponsors
Alimera Sciences
pSiVida Limited
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 50 or greater * Treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4-6 weeks apart) with no improvement in VA (worse or within one line better) or center subfield thickening (worse or within 30 um better). * Best Corrected Visual Acuity 20/320 or better in the study eye
Exclusion criteria
* Pregnant, lactating females or females of child bearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant , intrauterine device (IUD). * Glaucoma or ocular hypertension (defined as IOP \> 21 mmHg or concurrent therapy at screening with IOP-lowering agents) in the study eye * Laser or photodynamic therapy within 12 weeks of screening * Any ocular surgery in the study eye within 12 weeks of screening * Yag capsulotomy in the study eye within 15 days of screening * Treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy other than Lucentis within 6 months prior to enrollment (e.g., triamcinolone injection, Avastin, Macugen.) Systemic treatment with Avastin is also not allowed within 6 months prior to screening or at any time during the study. * Any change in systemic steroid therapy within 3 months of screening * Retinal or choroidal neovascularization due to ocular conditions other than AMD. * Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (e.g., ocular herpes simplex virus). * Known or suspected hypersensitivity to any of the ingredients of Lucentis, the investigational product or to other corticosteroids. * History of vitrectomy in the study eye * History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy * History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up * Any lens opacity which impairs visualization of the posterior pole * Participation in another clinical trial within 12 weeks before the screening visit or during the study * Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Visual Acuity | 6 mos | Visual acuity is measured using ETDRS charts at 4 meters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Developing Cataracts | 6 mos | — |
| Change in IOP From Baseline | 6 mos | IOP stands for intra ocular pressure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluocinolone Acetonide: 0.2 ug/Day Implant Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant | 4 |
| Fluocinolone Acetonide: 0.5 ug/Day Implant Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | Fluocinolone Acetonide: 0.5 ug/Day Implant | Fluocinolone Acetonide: 0.2 ug/Day Implant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 75.9 years STANDARD_DEVIATION 3.9 | 75.4 years STANDARD_DEVIATION 5.3 | 75.5 years STANDARD_DEVIATION 4.5 |
| Region of Enrollment United States | 2 participants | 4 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 4 | 2 / 2 |
| serious Total, serious adverse events | 4 / 4 | 1 / 2 |
Outcome results
Primary
Mean Change From Baseline in Visual Acuity
Visual acuity is measured using ETDRS charts at 4 meters.
Time frame: 6 mos
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluocinolone Acetonide: 0.2 ug/Day Implant | Mean Change From Baseline in Visual Acuity | 1.8 ETDRS letters | Standard Deviation 5.19 |
| Fluocinolone Acetonide: 0.5 ug/Day Implant | Mean Change From Baseline in Visual Acuity | 1.0 ETDRS letters | Standard Deviation 8.49 |
Secondary
Change in IOP From Baseline
IOP stands for intra ocular pressure
Time frame: 6 mos
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluocinolone Acetonide: 0.2 ug/Day Implant | Change in IOP From Baseline | 1.30 mmHg | Standard Deviation 5.81 |
| Fluocinolone Acetonide: 0.5 ug/Day Implant | Change in IOP From Baseline | 2.65 mmHg | Standard Deviation 1.91 |
Secondary
Number of Patients Developing Cataracts
Time frame: 6 mos
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluocinolone Acetonide: 0.2 ug/Day Implant | Number of Patients Developing Cataracts | 4 participants |
| Fluocinolone Acetonide: 0.5 ug/Day Implant | Number of Patients Developing Cataracts | 2 participants |