Status:
TERMINATED
Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
Lead Sponsor:
Alimera Sciences
Conditions:
Macular Edema
Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00770770
Start Date
May 1 2009
Last Update
May 28 2015
Active Locations (3)
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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