Research
Research is an important activity for the physicians of Retina Associates of New Jersey. By participating in clinical research, we are able to bring encouraging new treatments to patients who, otherwise, would have no available treatments. We are also able to apply the knowledge gained in these clinical studies to all of our patients in a timely manner. Three full time research coordinators administer the following clinical studies in which Retina Associates of New Jersey is presently participating:
BRANCH RETINAL VEIN OCCLUSION
STUDY
Branch retinal vein occlusion is the second most common vascular disorder of
the retina after diabetic retinopathy. Branch retinal vein occlusion occurs
where retinal arteries and veins cross. At these crossing points, the retinal
arteries and veins are bound together by common adventitial sheath tissue.
Because of this intimate association of retinal artery and vein walls, mechanical
narrowing of the vein due to arteriosclerosis is thought to be an important
cause of branch retinal vein occlusion. The vein is occluded by the thickened
artery, but the artery keeps pumping blood into the retina. When the capillary
system is overwhelmed by arterial blood continuing to be pumped, serum and
blood leak into the retina. Preliminary studies have demonstrated that microsurgical
separation of the retinal artery and vein at the point of branch retinal vein
occlusion is safe and improves retinal circulation visual acuity in some patients.
The purpose of this study is to determine the efficacy of this procedure in
patients with branch retinal vein occlusion.
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INTRAVITREAL IMPLANT FOR NON-INFECTIOUS UVEITIS
Uveitis is an inflammatory condition which can damage the retina. In severe
cases, treatment may be ineffective in preventing visual loss. A national
prospective, controlled, clinical trial has been established to evaluate
the safety and efficacy of a tiny (2 mm x 2 mm x 6 mm) steroid implant (Retisert)
surgically placed into the vitreous cavity. This implant contains an anti-inflammatory
drug (fluocinolone acetonide) which is slowly released inside the eye over
a period of three years For more information on this study you may visit
http://www.bausch.com/us/vision/concerns/uveitis/
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INTRAVITREAL IMPLANT FOR DIABETIC MACULAR EDEMA
Diabetic retinopathy causes leakage of blood components into the retina. When
fluid accumulates in the central portion (the macula) of the retina, the
condition is known as diabetic macular edema. Left untreated, approximately
one third of persons with clinically significant diabetic macular edema
will develop central visual loss within three years. Vascular endothelial
growth factor (VEGF) causes increased vascular leakage and promotes the
growth of abnormal blood vessels in the retina in diabetic retinopathy.
Preliminary studies have shown that the steroid, fluocinolone acetonide,
inhibits the production of VEGF and reduces diabetic macular edema. In
this study a tiny (2 mm x 2 mm x 6 mm) implant (Retisert) containing fluocinolone
acetonide is surgically placed into the vitreous cavity. This implant slowly
releases the medication inside the eye over a period of three years. The
purpose of this study is to determine the safety and efficiency of this
intravitreal implant in the long term treatment of diabetic macular edema.
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VIO STUDY (VISUDYNE IN OCCULT NEOVASCULARIZATION)
Visudyne is a photosensitizing dye which is administered intravenously and
activated with a low dose laser. This treatment is called photodynamic
therapy (PDT). Earlier studies have shown a beneficial effect of PDT for
the treatment of classic choroidal neovascularization (CNV) secondary to
age related macular degeneration. The purpose of this study is to determine
whether PDT in patients who have purely occult CNV lesions will safely
and significantly reduce the risk of vision loss. Patients who are more
than 50 years old and have age related macular degeneration with occult
CNV are candidates to participate in this study.
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RETANE (ANACORTAVE ACETATE) FOR THE TREATMENT OF CHOROIDAL NEOVASCULARIZATION IN AGE RELATED MACULAR DEGENERATION
Research has demonstrated that vascular endothelial growth factor (VEGF) is an important cause of abnormal, new blood vessels (choroidal neovascularization) and visual loss in age related macular degeneration. These abnormal vessels are a major cause of visual loss in this disease. Retane is one of a new class of compounds known as angiostatic cortizines which work by slowing or stopping the growth of new blood vessels. This clinical trial evaluates the safety and efficacy of Retane in patients with classic choroidal neovascularization. Patients in this study are randomized to either treatment with photodynamic therapy or to treatment with periocular Retane injections at six month intervals. Completion of the study is anticipated in 2005.
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RETANE (ANACORTAVE ACETATE) FOR PREVENTION OF CHOROIDAL NEOVASCULARIZATION IN AGE RELATED MACULAR DEGENERATION
Research has demonstrated that vascular endothelial growth factor (VEGF) is important in the development of abnormal, new blood vessels (choroidal neovascularization) in age related macular degeneration. These abnormal vessels are a major cause of visual loss in this disease. Retane is one of a new class of compounds known as angiostatic cortizines which work by slowing or stopping the growth of new blood vessels. Retane is being evaluated in patients with severe macular degeneration in one eye and high risk characteristics for the development of choroidal neovascularization in the fellow eye. The goal of the study is to determine whether Retane can reduce the risk of neovascularization in these high risk eyes. The better eye is treated with peribulbar injections (injections adjacent to the eye)of Retane every six months in an effort to prevent visual loss due to complications of macular degeneration. Retina Associates is one of one hundred sites throughout the world participating in this clinical trial.
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ORAL PROTEIN KINASE C INHIBITOR TO REDUCE DIABETIC MACULAR EDEMA
Diabetic retinopathy causes leakage of blood components into the retina. When fluid accumulates in the central portion (the macula) of the retina, the condition is known as diabetic macular edema. Left untreated, approximately one third of persons with clinically significant diabetic macular edema will develop central visual loss within three years. Vascular endothelial growth factor (VEGF) causes increased vascular leakage and promotes the growth of abnormal blood vessels in the retina in diabetic retinopathy. Another molecule, protein kinase C (PKC), must be present for VEGF to work. Preliminary studies have demonstrated that, in certain diabetic patients, the oral administration of a PKC inhibitor (ruboxistaurin) substantially reduced the incidence of clinically significant diabetic macular edema. The purpose of this prospective, controlled study is to determine whether or not oral ruboxistaurin taken daily for 36 months can reduce the risk of visually significant diabetic macular edema.
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INTRAVITREAL MEDICATION FOR NON-SURGICAL TREATMENT OF RETINAL DETACHMENT
Retinal detachments are most commonly caused by a hole or rip in the retina. Fluid from the vitreous cavity flows through the hole in the retina and accumulates beneath the retina causing the retina to separate or detach from the wall of the eye. These detachments can be repaired surgically in approximately 96% of cases. There is presently no non-surgical treatment of retinal detachments. This study is designed to determine the effectiveness of an intravitreal injection of medication to repair a retinal detachment without surgery. The medication injected stimulates the retinal pigment epithelium (the layer of cells behind the retina) to reabsorb fluid beneath the retina.
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STANDARD CARE VERSUS CORTICOSTEROID FOR RETINAL VEIN OCCLUSION ("SCORE")
Branch retinal vein occlusion (BRVO) is the second most common vascular disorder of the retina after diabetic retinopathy. BRVO occurs where retinal arteries and veins cross near the center of the retina. Central retinal vein occlusion (CRVO) is a less common, but potentially more serious, occlusion of the main vein that drains the retinal circulation. CRVO occurs within the optic nerve. In both BRVO and CRVO, serum and blood leak into the retina causing a swollen central retina (macular edema) and consequent poor vision. Laser treatment improves vision only in some cases of BRVO and is not useful in retinal swelling from CRVO . Preliminary studies have shown that injecting a steroid (triamcinalone) into the vitreous cavity in patients with BRVO and CRVO can produced resolution of retinal swelling and improvement of vision. This study, sponsored by the National Institutes of Health (NIH) will evaluate the roles of laser and intravitreal triamcinalone injections in patients with CRVO and BRVO.
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