Phase 2
N=6
The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot
Age Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00605423 ↗Enrolled (actual)
6
Serious AEs
83.3%
Results posted
Apr 2014
Primary outcome: Primary: Mean Change From Baseline in Visual Acuity — 1.8; 1.0 ETDRS letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluocinolone Acetonide/Medidur (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2011
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 | — |
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.
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.