Phase 2
Completed N=6
The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot
Source: ClinicalTrials.gov NCT00605423 ↗Enrolled (actual)
6
Serious AEs
83.3%
Results posted
Apr 2014
Primary outcomePrimary: Mean Change From Baseline in Visual Acuity — 1.8; 1.0 ETDRS letters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Visual Acuity |
1.8; 1.0 | — |
| SECONDARY Number of Patients Developing Cataracts |
4; 2 | — |
| SECONDARY Change in IOP From Baseline |
1.30; 2.65 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00605423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.