Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina (FAVOR)
This study is currently recruiting participants.
Verified August 2012 by Alimera Sciences
Sponsor:
Alimera Sciences
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT00770770
First received: October 9, 2008
Last updated: August 7, 2012
Last verified: August 2012
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Purpose
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Edema Retinal Vein Occlusion |
Drug: Fluocinolone Acetonide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
Drug Information available for:
Fluocinolone acetonide
U.S. FDA Resources
Further study details as provided by Alimera Sciences:
Primary Outcome Measures:
- Visual Acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
0.2 µg/day
|
Drug: Fluocinolone Acetonide
0.2 µg/day
|
|
Experimental: 2
0.5 µg/day
|
Drug: Fluocinolone Acetonide
0.5 µg/day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770770
Contacts
| Contact: Kathleen Billman | Kathleen.billman@alimerasciences.com |
Locations
| United States, Kentucky | |
| University of Kentucky Department of Ophthalmology | Recruiting |
| Lexington, Kentucky, United States | |
| Contact: Michele Reg 859-323-5868 mreg4@email.uky.edu | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States | |
| United States, Ohio | |
| Cole Eye Institute | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Rachel Rusnak 216-445-1256 rusnakr@ccf.org | |
Sponsors and Collaborators
Alimera Sciences
More Information
No publications provided
| Responsible Party: | Alimera Sciences |
| ClinicalTrials.gov Identifier: | NCT00770770 History of Changes |
| Other Study ID Numbers: | C-01-08-006 |
| Study First Received: | October 9, 2008 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alimera Sciences:
|
Macular edema secondary to RVO |
Additional relevant MeSH terms:
|
Edema Macular Edema Retinal Vein Occlusion Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Fluocinolone Acetonide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013