Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

• Sponsor: Alimera Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01304706
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Fluocinolone Acetonide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluocinolone Acetonide	Drug: Fluocinolone Acetonide; 0.2 μg/day

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [12 months]

   This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies.

2. In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN.

3. Ability and willingness to comply with the treatment and follow up procedures.

4. Ability to understand and sign the Informed Consent Form. No expectation that subject will be moving out of the area of the clinical center to an area not covered by another clinical center during the next 12 months.

Exclusion Criteria:

1. Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)

2. Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye

3. Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g., presumed ocular histoplasmosis, high myopia (spherical equivalent > 8 diopters), macular degeneration)

4. 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)

5. Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids

6. History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure

7. History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up

8. Any lens opacity which significantly impairs vision, in the opinion of the investigator.

9. Peripheral retinal detachment in prospective area of insertion

10. Participation in another clinical trial within 12 weeks before the screening visit or during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Alpharetta	Georgia	United States

Sponsors and Collaborators

• Alimera Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alimera Sciences
• ClinicalTrials.gov Identifier: NCT01304706
• Other Study ID Numbers: C-01-11-008
• First Posted: Feb 25, 2011
• Last Update Posted: May 4, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Macular Edema; Edema; Fluocinolone Acetonide

Study Results

Participant Flow

Arm/Group Title	Fluocinolone Acetonide
Arm/Group Description	Fluocinolone Acetonide: 0.2 μg/day
Period Title: Overall Study
STARTED	121
COMPLETED	104
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Fluocinolone Acetonide
Arm/Group Description	Fluocinolone Acetonide: 0.2 μg/day
Overall Participants	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.2 (9.29)
Age, Customized (participants) [Number]
<35	0 0%
35-44	3 2.5%
45-54	14 11.7%
55-64	42 35%
65-74	43 35.8%
75-84	17 14.2%
>=85	1 0.8%
Sex: Female, Male (Count of Participants)
Female	48 40%
Male	72 60%
Region of Enrollment (participants) [Number]
United States	120 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluocinolone Acetonide
Arm/Group Description	Fluocinolone Acetonide: 0.2 μg/day
Measure Participants	120
Adverse Event	100 83.3%
Serious Adverse Event	42 35%

Adverse Events

Arm/Group Title	Fluocinolone Acetonide
Arm/Group Description	Fluocinolone Acetonide: 0.2 μg/day
All Cause Mortality
	Fluocinolone Acetonide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fluocinolone Acetonide
	Affected / at Risk (%)	# Events
Total	42/120 (35%)
Cardiac disorders
Angina pectoris	2/120 (1.7%)	2
Bradycardia	1/120 (0.8%)	1
Cardiac failure congestive	2/120 (1.7%)	2
Cardio-respiratory arrest	1/120 (0.8%)	1
Coronary artery disease	4/120 (3.3%)	4
Myocardial infarction	5/120 (4.2%)	5
Eye disorders
Ocular hypertension	1/120 (0.8%)	1
Retinal detachment	1/120 (0.8%)	1
Vitreous haemorrhage	1/120 (0.8%)	1
Gastrointestinal disorders
Oesophagitis	1/120 (0.8%)	1
Pancreatitis	1/120 (0.8%)	1
General disorders
Chest pain	2/120 (1.7%)	2
Generalised oedema	1/120 (0.8%)	1
Infections and infestations
Osteomyelitis	1/120 (0.8%)	1
Pneumonia	1/120 (0.8%)	1
Sepsis	1/120 (0.8%)	1
Urinary tract infection	1/120 (0.8%)	1
Investigations
Intraocular pressure increased	3/120 (2.5%)	4
Metabolism and nutrition disorders
Gout	1/120 (0.8%)	1
Hypoglycaemia	1/120 (0.8%)	1
Musculoskeletal and connective tissue disorders
Osteonecrosis	1/120 (0.8%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia	1/120 (0.8%)	1
Rectal cancer	1/120 (0.8%)	1
Nervous system disorders
Cerebrovascular accident	1/120 (0.8%)	1
Syncope	1/120 (0.8%)	1
Renal and urinary disorders
Renal failure	1/120 (0.8%)	1
Renal failure chronic	1/120 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/120 (0.8%)	1
Nasal septum deviation	1/120 (0.8%)	1
Pulmonary embolism	1/120 (0.8%)	1
Pulmonary oedema	1/120 (0.8%)	1
Respiratory failure	1/120 (0.8%)	1
Surgical and medical procedures
Cataract operation	5/120 (4.2%)	5
Cataract operation	5/120 (4.2%)	5
Colostomy	1/120 (0.8%)	1
Glaucoma surgery	2/120 (1.7%)	2
Glaucoma surgery	1/120 (0.8%)	1
Surgery	1/120 (0.8%)	1
Trabeculectomy	1/120 (0.8%)	1
Trabeculoplasty	1/120 (0.8%)	1
Vitrectomy	5/120 (4.2%)	5
Vascular disorders
Hypertension	2/120 (1.7%)	2
Other (Not Including Serious) Adverse Events
	Fluocinolone Acetonide
	Affected / at Risk (%)	# Events
Total	100/120 (83.3%)
Blood and lymphatic system disorders
Anaemia	6/120 (5%)	6
Anaemia of chronic disease	1/120 (0.8%)	1
Cardiac disorders
Angina unstable	1/120 (0.8%)	1
Aortic valve sclerosis	1/120 (0.8%)	1
Arrhythmia	1/120 (0.8%)	1
Arteriosclerosis coronary artery	1/120 (0.8%)	1
Cardiac failure congestive	1/120 (0.8%)	1
Cardiomegaly	2/120 (1.7%)	2
Coronary artery disease	1/120 (0.8%)	1
Pericardial effusion	1/120 (0.8%)	1
Tachycardia	1/120 (0.8%)	1
Congenital, familial and genetic disorders
Arteriovenous malformation	1/120 (0.8%)	1
Ear and labyrinth disorders
Vertigo	2/120 (1.7%)	2
Endocrine disorders
Hyperparathyroidism secondary	1/120 (0.8%)	1
Hypothyroidism	4/120 (3.3%)	5
Eye disorders
Altered visual depth perception	1/120 (0.8%)	1
Blepharitis	3/120 (2.5%)	3
Blepharitis	3/120 (2.5%)	3
Borderline glaucoma	1/120 (0.8%)	1
Cataract	12/120 (10%)	15
Cataract	9/120 (7.5%)	10
Cataract cortical	1/120 (0.8%)	1
Cataract nuclear	1/120 (0.8%)	1
Cataract nuclear	1/120 (0.8%)	1
Cataract subcapsular	3/120 (2.5%)	3
Cataract subcapsular	2/120 (1.7%)	2
Conjunctival haemorrhage	28/120 (23.3%)	28
Conjunctival haemorrhage	2/120 (1.7%)	2
Conjunctival hyperaemia	2/120 (1.7%)	2
Conjunctivitis	1/120 (0.8%)	1
Conjunctivitis	1/120 (0.8%)	1
Corneal striae	1/120 (0.8%)	1
Corneal striae	1/120 (0.8%)	1
Deposit eye	1/120 (0.8%)	1
Diabetic retinal oedema	1/120 (0.8%)	1
Diabetic retinopathy	1/120 (0.8%)	1
Diabetic retinopathy	2/120 (1.7%)	2
Diplopia	1/120 (0.8%)	1
Diplopia	1/120 (0.8%)	1
Dry eye	5/120 (4.2%)	5
Dry eye	3/120 (2.5%)	3
Erythema of eyelid	1/120 (0.8%)	1
Erythema of eyelid	1/120 (0.8%)	1
Eye discharge	2/120 (1.7%)	2
Eye discharge	1/120 (0.8%)	1
Eye haemorrhage	2/120 (1.7%)	2
Eye irritation	2/120 (1.7%)	2
Eye irritation	1/120 (0.8%)	1
Eye pain	11/120 (9.2%)	13
Eye pruritus	2/120 (1.7%)	2
Eye pruritus	2/120 (1.7%)	2
Eyelid cyst	1/120 (0.8%)	1
Eyelid oedema	2/120 (1.7%)	2
Eyelid ptosis	1/120 (0.8%)	1
Eyelid ptosis	1/120 (0.8%)	1
Eyelids pruritus	1/120 (0.8%)	1
Foreign body sensation in eyes	1/120 (0.8%)	2
Glaucoma	3/120 (2.5%)	3
Glaucoma	1/120 (0.8%)	1
Halo vision	1/120 (0.8%)	1
Iris neovascularisation	1/120 (0.8%)	1
Keratitis	1/120 (0.8%)	1
Keratitis	1/120 (0.8%)	1
Lacrimation increased	1/120 (0.8%)	1
Macular degeneration	1/120 (0.8%)	1
Macular hole	1/120 (0.8%)	1
Macular oedema	1/120 (0.8%)	1
Maculopathy	5/120 (4.2%)	5
Maculopathy	2/120 (1.7%)	2
Metamorphopsia	1/120 (0.8%)	1
Myodesopsia	6/120 (5%)	7
Myodesopsia	2/120 (1.7%)	2
Ocular discomfort	1/120 (0.8%)	1
Ocular hyperaemia	5/120 (4.2%)	5
Ocular hypertension	7/120 (5.8%)	9
Ocular hypertension	1/120 (0.8%)	1
Open angle glaucoma	1/120 (0.8%)	1
Papilloedema	1/120 (0.8%)	1
Photophobia	4/120 (3.3%)	4
Photophobia	1/120 (0.8%)	1
Photopsia	2/120 (1.7%)	2
Posterior capsule opacification	1/120 (0.8%)	1
Retinal depigmentation	1/120 (0.8%)	1
Retinal detachment	1/120 (0.8%)	1
Retinal exudates	2/120 (1.7%)	2
Retinal exudates	3/120 (2.5%)	3
Retinal haemorrhage	1/120 (0.8%)	1
Retinal haemorrhage	3/120 (2.5%)	3
Retinal pigment epitheliopathy	1/120 (0.8%)	1
Vision blurred	3/120 (2.5%)	4
Visual acuity reduced	6/120 (5%)	6
Visual acuity reduced	2/120 (1.7%)	2
Visual impairment	2/120 (1.7%)	2
Visual impairment	2/120 (1.7%)	2
Vitreous detachment	3/120 (2.5%)	3
Vitreous detachment	1/120 (0.8%)	1
Vitreous haemorrhage	8/120 (6.7%)	8
Vitreous haemorrhage	5/120 (4.2%)	7
Vitritis	1/120 (0.8%)	1
Gastrointestinal disorders
Abdominal discomfort	2/120 (1.7%)	2
Abdominal pain	1/120 (0.8%)	1
Abdominal pain upper	1/120 (0.8%)	1
Constipation	4/120 (3.3%)	4
Diarrhoea	1/120 (0.8%)	1
Diverticulum intestinal	1/120 (0.8%)	1
Gastritis	1/120 (0.8%)	1
Gastrointestinal pain	1/120 (0.8%)	1
Gastrooesophageal reflux disease	3/120 (2.5%)	3
Gingival disorder	1/120 (0.8%)	1
Inguinal hernia	1/120 (0.8%)	1
Nausea	3/120 (2.5%)	3
Pneumoperitoneum	1/120 (0.8%)	1
Proctalgia	1/120 (0.8%)	1
General disorders
Fatigue	2/120 (1.7%)	2
Generalised oedema	1/120 (0.8%)	1
Malaise	1/120 (0.8%)	1
Pain	2/120 (1.7%)	2
Hepatobiliary disorders
Cholelithiasis	1/120 (0.8%)	1
Immune system disorders
Hypersensitivity	2/120 (1.7%)	2
Seasonal allergy	1/120 (0.8%)	1
Infections and infestations
Abdominal abscess	1/120 (0.8%)	1
Abscess limb	1/120 (0.8%)	1
Bronchitis	2/120 (1.7%)	2
Cellulitis	1/120 (0.8%)	1
Ear infection	1/120 (0.8%)	1
Gastritis viral	1/120 (0.8%)	1
Gastroenteritis viral	3/120 (2.5%)	3
Genital infection fungal	1/120 (0.8%)	1
Herpes zoster	1/120 (0.8%)	1
Histoplasmosis	1/120 (0.8%)	1
Infected cyst	1/120 (0.8%)	1
Influenza	2/120 (1.7%)	2
Localised infection	2/120 (1.7%)	2
Osteomyelitis	1/120 (0.8%)	1
Pneumonia	1/120 (0.8%)	1
Sinusitis	4/120 (3.3%)	5
Tooth abscess	1/120 (0.8%)	1
Upper respiratory tract infection	6/120 (5%)	6
Urinary tract infection	7/120 (5.8%)	8
Vaginal infection	1/120 (0.8%)	1
Injury, poisoning and procedural complications
Avulsion fracture	1/120 (0.8%)	1
Corneal abrasion	1/120 (0.8%)	1
Excoriation	1/120 (0.8%)	1
Fall	1/120 (0.8%)	1
Foot fracture	1/120 (0.8%)	1
Head injury	1/120 (0.8%)	1
Joint sprain	1/120 (0.8%)	1
Ligament rupture	1/120 (0.8%)	1
Muscle strain	1/120 (0.8%)	1
Procedural pain	5/120 (4.2%)	5
Therapeutic agent toxicity	1/120 (0.8%)	1
Tooth fracture	1/120 (0.8%)	1
Upper limb fracture	1/120 (0.8%)	1
Wound dehiscence	1/120 (0.8%)	1
Wrist fracture	1/120 (0.8%)	1
Investigations
Blood cholesterol increased	1/120 (0.8%)	1
Blood magnesium decreased	1/120 (0.8%)	1
Blood pressure increased	1/120 (0.8%)	1
Blood triglycerides increased	1/120 (0.8%)	1
Intraocular pressure increased	13/120 (10.8%)	15
Intraocular pressure increased	3/120 (2.5%)	3
Intraocular pressure test abnormal	1/120 (0.8%)	1
Platelet count increased	1/120 (0.8%)	1
Red blood cell count decreased	1/120 (0.8%)	1
Very low density lipoprotein increased	1/120 (0.8%)	1
White blood cell count increased	1/120 (0.8%)	1
Metabolism and nutrition disorders
Diabetes mellitus	1/120 (0.8%)	1
Diabetes mellitus inadequate control	1/120 (0.8%)	1
Gout	2/120 (1.7%)	3
Hyperkalaemia	2/120 (1.7%)	2
Hypocalcaemia	1/120 (0.8%)	1
Hyponatraemia	1/120 (0.8%)	1
Malnutrition	1/120 (0.8%)	1
Obesity	1/120 (0.8%)	1
Vitamin B12 deficiency	1/120 (0.8%)	1
Vitamin D deficiency	1/120 (0.8%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/120 (0.8%)	1
Arthritis	3/120 (2.5%)	3
Back pain	5/120 (4.2%)	6
Bone pain	1/120 (0.8%)	1
Exostosis	1/120 (0.8%)	1
Groin pain	1/120 (0.8%)	1
Head deformity	1/120 (0.8%)	1
Intervertebral disc protrusion	3/120 (2.5%)	3
Myalgia	1/120 (0.8%)	1
Osteoarthritis	1/120 (0.8%)	1
Pain in extremity	3/120 (2.5%)	4
Rhabdomyolysis	1/120 (0.8%)	1
Spinal column stenosis	2/120 (1.7%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma	1/120 (0.8%)	3
Nervous system disorders
Carpal tunnel syndrome	1/120 (0.8%)	2
Complex regional pain syndrome	1/120 (0.8%)	1
Demyelination	1/120 (0.8%)	1
Diabetic neuropathy	1/120 (0.8%)	1
Dizziness	2/120 (1.7%)	2
Encephalopathy	1/120 (0.8%)	1
Grand mal convulsion	1/120 (0.8%)	1
Headache	4/120 (3.3%)	4
Hypoaesthesia	2/120 (1.7%)	2
Neuritis	1/120 (0.8%)	1
Neuropathy peripheral	3/120 (2.5%)	3
Presyncope	1/120 (0.8%)	1
Sciatica	1/120 (0.8%)	2
Syncope	1/120 (0.8%)	1
Transient ischaemic attack	2/120 (1.7%)	2
VIth nerve paralysis	1/120 (0.8%)	1
Visual field defect	1/120 (0.8%)	1
Visual field defect	1/120 (0.8%)	1
Psychiatric disorders
Depression	2/120 (1.7%)	2
Insomnia	1/120 (0.8%)	1
Panic attack	1/120 (0.8%)	1
Renal and urinary disorders
Proteinuria	1/120 (0.8%)	1
Renal failure acute	3/120 (2.5%)	3
Renal failure chronic	4/120 (3.3%)	4
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/120 (0.8%)	1
Choking	1/120 (0.8%)	1
Cough	4/120 (3.3%)	4
Dyspnoea	5/120 (4.2%)	5
Hypoxia	1/120 (0.8%)	1
Lung infiltration	1/120 (0.8%)	1
Nasal septum deviation	1/120 (0.8%)	1
Orthopnoea	1/120 (0.8%)	1
Pleural effusion	1/120 (0.8%)	1
Pulmonary hypertension	1/120 (0.8%)	1
Sinus congestion	2/120 (1.7%)	2
Skin and subcutaneous tissue disorders
Cutis laxa	1/120 (0.8%)	1
Cutis laxa	1/120 (0.8%)	1
Dermal cyst	1/120 (0.8%)	1
Erythema	1/120 (0.8%)	3
Hyperhidrosis	1/120 (0.8%)	1
Hypoaesthesia facial	1/120 (0.8%)	1
Psoriasis	1/120 (0.8%)	1
Skin ulcer	1/120 (0.8%)	1
Vascular disorders
Aortic stenosis	1/120 (0.8%)	1
Arterial stenosis limb	1/120 (0.8%)	1
Arteriosclerosis	1/120 (0.8%)	1
Hypertension	4/120 (3.3%)	5
Hypotension	1/120 (0.8%)	1
Leriche syndrome	1/120 (0.8%)	1

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.