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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00605423
• Collaborator: Alimera Sciences (Industry), pSiVida Limited (Industry)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: Fluocinolone Acetonide/Medidur; Drug: Fluocinolone Acetonide/Medidur	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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™
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Visual Acuity [6 mos]

   Visual acuity is measured using ETDRS charts at 4 meters.

Secondary Outcome Measures

1. Number of Patients Developing Cataracts [6 mos]

2. Change in IOP From Baseline [6 mos]

   IOP stands for intra ocular pressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter A Campochiaro, MD, Principal Investigator, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00605423
• Other Study ID Numbers: NA 00012714
• First Posted: Jan 31, 2008
• Last Update Posted: Apr 7, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Peter A Campochiaro, MD, Principal Investigator, Johns Hopkins University: AMD; Almera; Steroid; Macular; ARMD
• Additional relevant MeSH terms: Macular Degeneration; Fluocinolone Acetonide

Study Results

Participant Flow

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Arm/Group Description	Dose 0.2 ug/day Medidur implant	Dose 0.5 ug/day Medidur implant
Period Title: Overall Study
STARTED	4	2
COMPLETED	4	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant	Total
Arm/Group Description	Dose 0.2 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.2 ug/day implant	Dose 0.5 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.5 ug/day implant	Total of all reporting groups
Overall Participants	4	2	6
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 25%	1 50%	2 33.3%
>=65 years	3 75%	1 50%	4 66.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.4 (5.3)	75.9 (3.9)	75.5 (4.5)
Sex: Female, Male (Count of Participants)
Female	1 25%	1 50%	2 33.3%
Male	3 75%	1 50%	4 66.7%
Region of Enrollment (participants) [Number]
United States	4 100%	2 100%	6 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Visual Acuity
Description	Visual acuity is measured using ETDRS charts at 4 meters.
Time Frame	6 mos

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Arm/Group Description	Dose 0.2 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.2 ug/day implant	Dose 0.5 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
Measure Participants	4	2
Mean (Standard Deviation) [ETDRS letters]	1.8 (5.19)	1.0 (8.49)

2. Secondary Outcome

Title	Number of Patients Developing Cataracts
Time Frame	6 mos

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Arm/Group Description	Dose 0.2 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.2 ug/day implant	Dose 0.5 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
Measure Participants	4	2
Number [participants]	4 100%	2 100%

3. Secondary Outcome

Title	Change in IOP From Baseline
Description	IOP stands for intra ocular pressure
Time Frame	6 mos

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Arm/Group Description	Dose 0.2 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.2 ug/day implant	Dose 0.5 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
Measure Participants	4	2
Mean (Standard Deviation) [mmHg]	1.30 (5.81)	2.65 (1.91)

Adverse Events

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant		Fluocinolone Acetonide: 0.5 ug/Day Implant
Arm/Group Description	Dose 0.2 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.2 ug/day implant		Dose 0.5 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
All Cause Mortality
	Fluocinolone Acetonide: 0.2 ug/Day Implant		Fluocinolone Acetonide: 0.5 ug/Day Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fluocinolone Acetonide: 0.2 ug/Day Implant		Fluocinolone Acetonide: 0.5 ug/Day Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		1/2 (50%)
Surgical and medical procedures
Cataract Operation	4/4 (100%)	4	1/2 (50%)	1
Cataract Operation Complication	1/4 (25%)	1	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	Fluocinolone Acetonide: 0.2 ug/Day Implant		Fluocinolone Acetonide: 0.5 ug/Day Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		2/2 (100%)
Eye disorders
Cataract	3/4 (75%)	3	2/2 (100%)	2
Cataract Subcapsular	1/4 (25%)	3	0/2 (0%)	0
Injury, poisoning and procedural complications
Contrast Media Reaction	1/4 (25%)	1	0/2 (0%)	0
Investigations
Intraocular Pressure Increased	1/4 (25%)	1	1/2 (50%)	1
Metabolism and nutrition disorders
Gout	1/4 (25%)	1	0/2 (0%)	0
Surgical and medical procedures
Cataract Operation Complication	1/4 (25%)	1	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.