The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot
Completed · Phase 2
Conditions studied: Age Related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT00605423
- Run by
- Johns Hopkins University
- People needed
- 6
- Starts
- 2008-01-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2014-04-07
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Wilmer Eye Institute, Johns Hopkins University — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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