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

This study has been completed.
Sponsor:
Collaborators:
Alimera Sciences
pSiVida Limited
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00605423
First received: January 17, 2008
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: Fluocinolone Acetonide/Medidur
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Mean Change From Baseline in Visual Acuity [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
    Visual acuity is measured using ETDRS charts at 4 meters.


Secondary Outcome Measures:
  • Number of Patients Developing Cataracts [ Time Frame: 6 mos ] [ Designated as safety issue: Yes ]
  • Change in IOP From Baseline [ Time Frame: 6 mos ] [ Designated as safety issue: Yes ]
    IOP stands for intra ocular pressure


Enrollment: 6
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Dose 0.2 ug/day Medidur implant
Drug: Fluocinolone Acetonide/Medidur
0.2 ug/day implant
Active Comparator: 2
Dose 0.5 ug/day Medidur implant
Drug: Fluocinolone Acetonide/Medidur
0.5 ug/day implant

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605423

Locations
United States, Maryland
Wilmer Eye Institute, Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Alimera Sciences
pSiVida Limited
Investigators
Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Peter A Campochiaro, MD, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00605423     History of Changes
Other Study ID Numbers: NA 00012714
Study First Received: January 17, 2008
Results First Received: September 20, 2013
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
AMD
Almera
Steroid
Macular
ARMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014