FAVOR: Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

• Sponsor: Alimera Sciences (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00770770
• Collaborator: (none)
• Enrollment: 20
• Locations: 3
• Arms: 2
• Patients Per Site: 6.7

Study Details

Study Description

Brief Summary

This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; Retinal Vein Occlusion	Drug: Fluocinolone Acetonide; Drug: Fluocinolone Acetonide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-masked, Pilot Study of the Safety and Efficacy of 0.5 µg/Day and 0.2 µg/Day Iluvien™ (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg in Subjects With Macular Edema Secondary to Retinal Vein Occlusion
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluocinolone Acetonide 0.2 µg/day 0.2 µg/day	Drug: Fluocinolone Acetonide; 0.2 µg/day
Experimental: Fluocinolone Acetonide 0.5 µg/day 0.5 µg/day	Drug: Fluocinolone Acetonide; 0.5 µg/day

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [3 months]

   To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

• Central subfield thickness > 300 μm

• BCVA of ≥ 24 and ≤ 68 letters

• Males and non-pregnant females 18 years and over

Exclusion Criteria:

• Macular edema secondary to any condition other than RVO

• Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye

• Cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss

• Glaucoma or ocular hypertension (IOP > 21 mmHg or concurrent therapy at screening with IOP-lowering agents)

• Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye

• Any change in systemic steroid therapy within 3 months of screening

• History of vitrectomy in the study eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky Department of Ophthalmology	Lexington	Kentucky	United States
2	Ophthalmic Consultants of Boston	Boston	Massachusetts	United States
3	Cole Eye Institute	Cleveland	Ohio	United States	44195

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: NCT00770770
• Other Study ID Numbers: C-01-08-006
• First Posted: Oct 10, 2008
• Last Update Posted: May 28, 2015
• Last Verified: May 1, 2015

• Keywords provided by Alimera Sciences: Macular edema secondary to RVO
• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema; Fluocinolone Acetonide

Study Results

Participant Flow

Arm/Group Title	Fluocinolone Acetonide: 0.2 µg/Day	Fluocinolone Acetonide: 0.5 µg/Day
Arm/Group Description	Fluocinolone Acetonide: 0.2 µg/day	Fluocinolone Acetonide: 0.5 µg/day
Period Title: Overall Study
STARTED	14	6
COMPLETED	4	5
NOT COMPLETED	10	1

Baseline Characteristics

Arm/Group Title	Fluocinolone Acetonide 0.2 µg/Day	Fluocinolone Acetonide 0.5 µg/Day	Total
Arm/Group Description	0.2 µg/day Fluocinolone Acetonide: 0.2 µg/day	0.5 µg/day Fluocinolone Acetonide: 0.5 µg/day	Total of all reporting groups
Overall Participants	14	6	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.50 (9.287)	73.52 (13.091)	69.30 (10.589)
Age, Customized (participants) [Number]
<35 years	0 0%	0 0%	0 0%
35-45 years	0 0%	0 0%	0 0%
45-55 years	2 14.3%	0 0%	2 10%
55-65 years	3 21.4%	2 33.3%	5 25%
65-75 years	6 42.9%	0 0%	6 30%
75-85 years	2 14.3%	3 50%	5 25%
≥85 years	1 7.1%	1 16.7%	2 10%
Sex: Female, Male (Count of Participants)
Female	7 50%	4 66.7%	11 55%
Male	7 50%	2 33.3%	9 45%
Region of Enrollment (participants) [Number]
United States	14 100%	6 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluocinolone Acetonide 0.2 µg/Day	Fluocinolone Acetonide 0.5 µg/Day
Arm/Group Description	0.2 µg/day Fluocinolone Acetonide: 0.2 µg/day	0.5 µg/day Fluocinolone Acetonide: 0.5 µg/day
Measure Participants	14	6
Baseline	47.0 (4.50)	53.5 (4.13)
Month 3 - Change from Baseline	7.0 (2.51)	9.2 (2.37)

Adverse Events

Arm/Group Title	Fluocinolone Acetonide: 0.2 µg/Day		Fluocinolone Acetonide: 0.5 µg/Day
Arm/Group Description	Fluocinolone Acetonide: 0.2 µg/day		Fluocinolone Acetonide: 0.5 µg/day
All Cause Mortality
	Fluocinolone Acetonide: 0.2 µg/Day		Fluocinolone Acetonide: 0.5 µg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fluocinolone Acetonide: 0.2 µg/Day		Fluocinolone Acetonide: 0.5 µg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/14 (57.1%)		4/6 (66.7%)
Cardiac disorders
Angina pectoris	2/14 (14.3%)	2	0/6 (0%)	0
Arrhythmia	0/14 (0%)	0	1/6 (16.7%)	1
Eye disorders
Retinal detachment	1/14 (7.1%)	1	0/6 (0%)	0
Infections and infestations
Pneumonia	1/14 (7.1%)	1	0/6 (0%)	0
Pseudomonas infection	1/14 (7.1%)	1	0/6 (0%)	0
Injury, poisoning and procedural complications
Contusion	1/14 (7.1%)	1	0/6 (0%)	0
Metabolism and nutrition disorders
Hyponatraemia	1/14 (7.1%)	1	0/6 (0%)	0
Nervous system disorders
Cerebrovascular accident	1/14 (7.1%)	1	0/6 (0%)	0
Psychiatric disorders
Major depression	1/14 (7.1%)	1	0/6 (0%)	0
Mental disorder	1/14 (7.1%)	1	0/6 (0%)	0
Renal and urinary disorders
Bladder obstruction	1/14 (7.1%)	2	0/6 (0%)	0
Respiratory, thoracic and mediastinal disorders
Orthopnoea	1/14 (7.1%)	1	0/6 (0%)	0
Surgical and medical procedures
Cardiac pacemaker replacement	1/14 (7.1%)	1	0/6 (0%)	0
Cataract operation	3/14 (21.4%)	3	3/6 (50%)	3
Cataract operation	2/14 (14.3%)	2	0/6 (0%)	0
Other (Not Including Serious) Adverse Events
	Fluocinolone Acetonide: 0.2 µg/Day		Fluocinolone Acetonide: 0.5 µg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/14 (92.9%)		6/6 (100%)
Blood and lymphatic system disorders
Anaemia	1/14 (7.1%)	1	1/6 (16.7%)	1
Cardiac disorders
Angina pectoris	2/14 (14.3%)	2	0/6 (0%)	0
Cardiac failure congestive	1/14 (7.1%)	1	0/6 (0%)	0
Tachycardia	0/14 (0%)	0	1/6 (16.7%)	1
Ear and labyrinth disorders
Cerumen impaction	0/14 (0%)	0	1/6 (16.7%)	1
Vertigo	1/14 (7.1%)	1	0/6 (0%)	0
Endocrine disorders
Hypothyroidism	1/14 (7.1%)	1	0/6 (0%)	0
Eye disorders
Cataract	2/14 (14.3%)	2	4/6 (66.7%)	4
Cataract	3/14 (21.4%)	3	1/6 (16.7%)	1
Cataract subcapsular	1/14 (7.1%)	1	0/6 (0%)	0
Conjunctival haemorrhage	1/14 (7.1%)	1	1/6 (16.7%)	1
Diabetic retinopathy	1/14 (7.1%)	1	0/6 (0%)	0
Diplopia	1/14 (7.1%)	1	0/6 (0%)	0
Diplopia	1/14 (7.1%)	1	0/6 (0%)	0
Dry eye	1/14 (7.1%)	1	1/6 (16.7%)	1
Dry eye	1/14 (7.1%)	1	0/6 (0%)	0
Eye irritation	1/14 (7.1%)	1	0/6 (0%)	0
Eye pain	3/14 (21.4%)	3	1/6 (16.7%)	1
Eye pain	1/14 (7.1%)	1	0/6 (0%)	0
Iris neovascularisation	1/14 (7.1%)	1	0/6 (0%)	0
Myodesopsia	2/14 (14.3%)	2	1/6 (16.7%)	1
Ocular hyperaemia	2/14 (14.3%)	2	0/6 (0%)	0
Optic atrophy	1/14 (7.1%)	1	0/6 (0%)	0
Optic disc haemorrhage	0/14 (0%)	0	1/6 (16.7%)	1
Optic disc vascular disorder	1/14 (7.1%)	1	1/6 (16.7%)	1
Papilloedema	0/14 (0%)	0	1/6 (16.7%)	2
Photophobia	2/14 (14.3%)	2	0/6 (0%)	0
Photopsia	1/14 (7.1%)	1	0/6 (0%)	0
Retinal aneurysm	1/14 (7.1%)	1	0/6 (0%)	0
Retinal haemorrhage	1/14 (7.1%)	1	1/6 (16.7%)	1
Retinal neovascularisation	1/14 (7.1%)	1	0/6 (0%)	0
Retinal oedema	0/14 (0%)	0	1/6 (16.7%)	1
Visual acuity reduced	1/14 (7.1%)	2	0/6 (0%)	0
Vitreous detachment	1/14 (7.1%)	1	0/6 (0%)	0
Vitreous detachment	1/14 (7.1%)	1	0/6 (0%)	0
Gastrointestinal disorders
Abdominal distension	0/14 (0%)	0	1/6 (16.7%)	1
Constipation	3/14 (21.4%)	4	0/6 (0%)	0
Diarrhoea	1/14 (7.1%)	1	0/6 (0%)	0
Dyspepsia	1/14 (7.1%)	1	0/6 (0%)	0
Gastrooesophageal reflux disease	2/14 (14.3%)	3	0/6 (0%)	0
General disorders
Pyrexia	2/14 (14.3%)	2	0/6 (0%)	0
Sensation of foreign body	2/14 (14.3%)	2	0/6 (0%)	0
Infections and infestations
Bronchitis	1/14 (7.1%)	1	0/6 (0%)	0
Ear infection	0/14 (0%)	0	1/6 (16.7%)	1
Gastroenteritis	1/14 (7.1%)	1	0/6 (0%)	0
Nasopharyngitis	1/14 (7.1%)	1	1/6 (16.7%)	1
Pneumonia	0/14 (0%)	0	1/6 (16.7%)	1
Pseudomonas infection	1/14 (7.1%)	1	0/6 (0%)	0
Sinusitis	2/14 (14.3%)	3	0/6 (0%)	0
Upper respiratory tract infection	1/14 (7.1%)	1	0/6 (0%)	0
Urinary tract infection	3/14 (21.4%)	6	0/6 (0%)	0
Injury, poisoning and procedural complications
Contrast media reaction	1/14 (7.1%)	1	1/6 (16.7%)	1
Contusion	1/14 (7.1%)	1	0/6 (0%)	0
Humerus fracture	0/14 (0%)	0	1/6 (16.7%)	1
Thermal burn	1/14 (7.1%)	1	0/6 (0%)	0
Investigations
Intraocular pressure increased	3/14 (21.4%)	3	0/6 (0%)	0
Intraocular pressure increased	1/14 (7.1%)	1	0/6 (0%)	0
Metabolism and nutrition disorders
Gout	0/14 (0%)	0	1/6 (16.7%)	1
Hyperlipidaemia	1/14 (7.1%)	1	0/6 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	1/14 (7.1%)	2	0/6 (0%)	0
Neck pain	1/14 (7.1%)	1	0/6 (0%)	0
Nervous system disorders
Dizziness	1/14 (7.1%)	1	0/6 (0%)	0
Hemianopia	1/14 (7.1%)	1	0/6 (0%)	0
Hemianopia	1/14 (7.1%)	1	0/6 (0%)	0
Psychiatric disorders
Anxiety	1/14 (7.1%)	1	0/6 (0%)	0
Insomnia	1/14 (7.1%)	1	0/6 (0%)	0
Renal and urinary disorders
Bladder obstruction	1/14 (7.1%)	3	0/6 (0%)	0
Urinary incontinence	1/14 (7.1%)	1	0/6 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/14 (7.1%)	1	0/6 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/14 (0%)	0	1/6 (16.7%)	1
Oropharyngeal pain	1/14 (7.1%)	1	0/6 (0%)	0
Orthopnoea	1/14 (7.1%)	1	0/6 (0%)	0
Rhinitis allergic	0/14 (0%)	0	1/6 (16.7%)	1
Vascular disorders
Hypertension	1/14 (7.1%)	2	0/6 (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.