NEWS HIGHLIGHTS
Published Studies Related to Retisert (Fluocinolone Intravitreal)
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.
Photoreceptor neuroprotection in RCS rats via low-dose intravitreal sustained-delivery of fluocinolone acetonide. [2009.10]
PURPOSE: To study the neuroprotective effects of intravitreal fluocinolone acetonide (FA) in Royal College of Surgeons (RCS) rats... CONCLUSIONS: Chronic intravitreal infusion of FA is neuroprotective in RCS rats, preserves ONL morphology and ERG amplitudes and reduces retinal neuroinflammation. These findings may have a therapeutic role in human photoreceptor cell degenerations.
Management of sympathetic ophthalmia with the fluocinolone acetonide implant. [2009.03]
OBJECTIVE: We examined whether implantation of the fluocinolone acetonide (Retisert) implant achieved control of inflammation and a reduced need for oral corticosteroids or immunosuppressives in patients with sympathetic ophthalmia (SO). DESIGN: Retrospective, noncomparative case series. PARTICIPANTS: Eight patients with active SO... CONCLUSIONS: The fluocinolone acetonide implant provides inflammatory control and reduces the dependence on systemic immunosuppression in patients with SO.
Fluocinolone acetonide sustained drug delivery device for chronic central retinal vein occlusion: 12-month results. [2008.08]
PURPOSE: To determine treatment outcomes of a long-acting intravitreal fluocinolone acetonide sustained drug delivery implant in eyes with central retinal vein occlusion (CRVO) and chronic refractory macular edema. DESIGN: Prospective, noncomparative, interventional case series... CONCLUSIONS: VA improved and macular edema decreased in a significant proportion of implanted eyes with chronic, CRVO-associated macular edema. Cataract formation and elevated IOP, the main side effects, were managed, respectively, with cataract extraction and medical or surgical IOP control, or both. This system is a promising novel alternative to currently available treatments for this challenging patient population.
Clinical Trials Related to Retisert (Fluocinolone Intravitreal)
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.
Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema [Completed]
This was a multi-center, randomized, masked, parallel-group, controlled study in patients
with diabetic macular edema, comparing RetisertTM (0. 59 mg) with control therapy (standard of
care (SOC) – repeat macular grid laser or observation). The objective was to evaluate the
safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of
patients with 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.
A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion [Recruiting]
The purpose of this study is to determine whether a fluocinolone sustained drug delivery
implant is effective in the treatment of central retinal vein occlusion that has caused
persistent macular edema and decreased visual acuity.
Re-Implantation of a Fluocinolone Acetonide Implant for Non-Infectious Uveitis Affecting the Posterior Segment [Recruiting]
The purpose of this study is to collect data on patients with severe uveitis that have
required re-implantation of the sustained-release fluocinolone drug delivery device due to
depletion of study drug in their previous implanted device.
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