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Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina (FAVOR)

Primary Purpose

Macular Edema, Retinal Vein Occlusion

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluocinolone Acetonide
Fluocinolone Acetonide
Sponsored by
Alimera Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Macular edema secondary to RVO

Eligibility Criteria

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

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

Sites / Locations

  • University of Kentucky Department of Ophthalmology
  • Ophthalmic Consultants of Boston
  • Cole Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fluocinolone Acetonide 0.2 µg/day

Fluocinolone Acetonide 0.5 µg/day

Arm Description

0.2 µg/day

0.5 µg/day

Outcomes

Primary Outcome Measures

Visual Acuity
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.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2008
Last Updated
May 8, 2015
Sponsor
Alimera Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00770770
Brief Title
Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
Acronym
FAVOR
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alimera Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion
Keywords
Macular edema secondary to RVO

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Fluocinolone Acetonide 0.2 µg/day
Arm Type
Experimental
Arm Description
0.2 µg/day
Arm Title
Fluocinolone Acetonide 0.5 µg/day
Arm Type
Experimental
Arm Description
0.5 µg/day
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide
Intervention Description
0.2 µg/day
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide
Intervention Description
0.5 µg/day
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Kentucky Department of Ophthalmology
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

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