CLINICAL TRIALS PROFILE FOR FLUOCINOLONE ACETONIDE
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All Clinical Trials for FLUOCINOLONE ACETONIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00008515 ↗ | Fluocinolone Implant to Treat Macular Degeneration | Completed | National Eye Institute (NEI) | Phase 1 | 2001-01-01 | This study will test the safety and effectiveness of a fluocinolone implant to treat age-related macular degeneration. This eye disease can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. It is the leading cause of vision loss in people over age 60. The fluocinolone implant is a tiny plastic rod with a pellet of the steroid fluocinolone on the end. The pellet slowly dissolves and releases the medication into the fluid in the eye. Vision loss in macular degeneration is caused by the formation of new blood vessels in the choroid-a thin, pigmented vascular layer of the eye behind the retina. These abnormal vessels leak blood under the macula, the part of the retina that determines central vision. Tissue studies show evidence of inflammation in the retinas of patients. This study will test whether the slow release of the steroid fluocinolone directly into the affected part of the eye can prevent or slow further vision loss. Preliminary animal and human studies with fluocinolone implants have shown some benefit in reducing blood vessel growth and improving or stabilizing vision. Patients 50 years of age and older with age-related macular degeneration may be eligible for this study. Study patients will be randomly assigned to one of two treatment groups. One will receive a 0.5-mg dose implant; the other will receive a 2-mg dose implant. Theoretically, the implants can release the medicine for 2 to 3 years. Participants will have a medical history, physical examination and complete eye examination. The latter will include a vision test, eye pressure measurement, examination of the pupils, lens, retina, and eye movements. Photographs of the eye will be taken with a special camera. Patients will also undergo fluorescein angiography, a test that takes pictures of the retina using a yellow dye called sodium fluorescein. The dye is injected into the blood stream through a vein. After it reaches the blood vessels of the eye, photographs are taken of the retina. When the above tests are completed, patients will be scheduled for surgery to place the implant. The procedure will be done under either local or general anesthesia. Follow-up visits will be scheduled 1, 2, 4, and 6 weeks after surgery, then at 3 and 6 months after surgery, and then every 6 months until the implant is depleted of medicine or is removed. Several of the exams described above will be repeated during the follow-up period to evaluate the treatment and side effects, if any. |
| NCT00132691 ↗ | Multicenter Uveitis Steroid Treatment (MUST) Trial | Completed | National Eye Institute (NEI) | Phase 4 | 2005-09-01 | The purpose of this study is to compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis. |
| NCT00132691 ↗ | Multicenter Uveitis Steroid Treatment (MUST) Trial | Completed | JHSPH Center for Clinical Trials | Phase 4 | 2005-09-01 | The purpose of this study is to compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis. |
| NCT00344968 ↗ | Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema | Completed | Alimera Sciences | Phase 3 | 2007-09-01 | This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema. |
| NCT00407082 ↗ | Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants | Completed | Bausch & Lomb Incorporated | Phase 2/Phase 3 | 2000-12-01 | This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide. |
| NCT00456482 ↗ | Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant | Terminated | Bausch & Lomb Incorporated | Phase 2/Phase 3 | 2002-05-01 | This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide. |
| NCT00468871 ↗ | Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy | Completed | Bausch & Lomb Incorporated | Phase 2/Phase 3 | 2002-04-01 | This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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