NEWS HIGHLIGHTS
Published Studies Related to Synalar (Fluocinolone Topical)
Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. [2008.09]
OBJECTIVES: To evaluate the safety and efficacy of 0.59-mg and 2.1-mg fluocinolone acetonide (FA) intravitreous implants in noninfectious posterior uveitis... CONCLUSIONS: The FA implant significantly reduced uveitis recurrence and improved or stabilized visual acuity in subjects with noninfectious posterior uveitis. Most subjects required cataract extraction, and a significant proportion required intraocular pressure-lowering surgery. APPLICATION TO CLINICAL PRACTICE: The FA implant provides an alternative therapy for prolonged control of inflammation in noninfectious posterior uveitis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00407082.
A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma. [2008.09]
BACKGROUND: Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge. OBJECTIVES: To compare the efficacy and safety of a triple combination [TC: fluocinolone acetonide 0.01%, hydroquinone (HQ) 4%, tretinoin 0.05%] vs. HQ 4% after 8 weeks of treatment of moderate to severe facial melasma in Asian patients... CONCLUSIONS: Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.
A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma. [2008.06.28]
Background Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge... Conclusions Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.
Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. [2006.06]
PURPOSE: To report the interim 34-week safety and efficacy results of a 3-year study to evaluate an investigational intravitreal fluocinolone acetonide (FA) implant in patients with noninfectious posterior uveitis. DESIGN: Prospective, dose-masked, dose-randomized, historically controlled, multicenter trial in patients with unilateral or bilateral disease. PARTICIPANTS: A total of 278 patients with recurrent noninfectious posterior uveitis were randomized to receive a 0.59-mg (n = 110) or 2.1-mg (n = 168) implant. In patients with bilateral disease, the more severely affected eye received the implant... CONCLUSIONS: The FA implant significantly reduced uveitis recurrences, improved VA, and decreased the need for adjunctive therapy in the studied patient population. The most common side effects included increased intraocular pressure and cataract progression.
Long-term follow-up results of a pilot trial of a fluocinolone acetonide implant to treat posterior uveitis. [2005.07]
PURPOSE: To investigate the safety and efficacy of a fluocinolone acetonide intravitreal implant in the treatment of noninfectious posterior uveitis. DESIGN: Noncomparative interventional case series, dose randomized, dose masked, prospective. PARTICIPANTS: Thirty-six eyes of 32 patients with a history of recurrent noninfectious posterior uveitis... CONCLUSION: The fluocinolone acetonide intravitreal implant effectively controlled intraocular inflammation in the studied population. Elevated IOP and cataracts that occurred in fluocinolone device-implanted eyes were managed by standard means. The fluocinolone acetonide sustained drug delivery implant seems to be promising in patients with posterior uveitis who do not respond to or are intolerant to conventional treatment.
Clinical Trials Related to Synalar (Fluocinolone Topical)
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema [Active, not recruiting]
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert
of fluocinolone acetonide for the treatment of diabetic macular edema
Retisert and Cataract Surgery in Patients With Severe Uveitis [Completed]
To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone
acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation
when combined with phacoemulsification and posterior chamber intraocular lens implantation
(phaco/PCIOL) in eyes with severe uveitis.
Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO) [Recruiting]
Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is
effective in the treatment of retinal vein occlusion that has caused persistent macular
edema and decreased visual acuity.
Hypothesis: A fluocinolone acetonide sustained drug delivery implant will be a safe and
effective method to treat patients with macular edema and decreased vision from retinal vein
occlusion.
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema [Active, not recruiting]
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone
acetonide for the treatment of diabetic macular edema.
Fluocinolone Implant to Treat Macular Degeneration [Completed]
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.
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