The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot

Age Related Macular Degeneration Clinical Trial

— MAP  

Official title:

A Single Masked, Randomized Comparison of the Safety and Efficacy of 0.2 and 0.5 µg/Day Fluocinolone Acetonide/Medidur™ in Patients With Exudative Age Related Macular Degeneration Who Have Received Lucentis™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605423
• Other study ID #: NA 00012714
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2008
• Last updated: March 10, 2014
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: March 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Fluocinolone Acetonide/Medidur
0.2 ug/day implant
• Fluocinolone Acetonide/Medidur
0.5 ug/day implant

Locations

Country	Name	City	State
United States	Wilmer Eye Institute, Johns Hopkins University	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Alimera Sciences, pSiVida Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Visual Acuity	Visual acuity is measured using ETDRS charts at 4 meters.	6 mos	No
Secondary	Number of Patients Developing Cataracts		6 mos	Yes
Secondary	Change in IOP From Baseline	IOP stands for intra ocular pressure	6 mos	Yes