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

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluocinolone Acetonide/Medidur
Fluocinolone Acetonide/Medidur
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring AMD, Almera, Steroid, Macular, ARMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wilmer Eye Institute, Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Dose 0.2 ug/day Medidur implant

Dose 0.5 ug/day Medidur implant

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Visual Acuity
Visual acuity is measured using ETDRS charts at 4 meters.

Secondary Outcome Measures

Number of Patients Developing Cataracts
Change in IOP From Baseline
IOP stands for intra ocular pressure

Full Information

First Posted
January 17, 2008
Last Updated
March 10, 2014
Sponsor
Johns Hopkins University
Collaborators
Alimera Sciences, pSiVida Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00605423
Brief Title
The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot
Acronym
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™
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Alimera Sciences, pSiVida Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
AMD, Almera, Steroid, Macular, ARMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Dose 0.2 ug/day Medidur implant
Arm Title
2
Arm Type
Active Comparator
Arm Description
Dose 0.5 ug/day Medidur implant
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide/Medidur
Intervention Description
0.2 ug/day implant
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide/Medidur
Intervention Description
0.5 ug/day implant
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Visual Acuity
Description
Visual acuity is measured using ETDRS charts at 4 meters.
Time Frame
6 mos
Secondary Outcome Measure Information:
Title
Number of Patients Developing Cataracts
Time Frame
6 mos
Title
Change in IOP From Baseline
Description
IOP stands for intra ocular pressure
Time Frame
6 mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Campochiaro, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilmer Eye Institute, Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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